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An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
12 October 2016 EMA/270645/2015 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: carboplatin
Procedure no.: PSUSA/00000559/201601
List of nationally authorised medicinal products EMA/753864/2016 Page 2/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bopacatin 10 mg/ml Concentrate for solution for infusion
DE/H/1222/001 44/0594/10-S ACTAVIS GROUP PTC EHF. SK
Bopacatin 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/1222/001 H/10/00300/001 H/10/00300/002 H/10/00300/003 H/10/00300/004
ACTAVIS GROUP PTC EHF. SI
Bopacatin 10 mg/ml, koncentrátum oldatos infúzióhoz
DE/H/1222/001 OGYI-T-21360/01-04 ACTAVIS GROUP PTC EHF. HU
CARBATACIN not available 13492/24-07-2015 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
CARBO-cell® 10 mg/ml Infusionslösung
not available 46297.00.00 CELL PHARM GMBH DE
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
not available 46298.00.00 CELL PHARM GMBH DE
Carbomedac 10 mg/ml infúzny koncentrát
DE/H/0803/001 44/0166/09-S MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SK
Carbomedac 10 mg/ml koncentrát pro infuzní roztok
DE/H/0803/001 44/271/09-C MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
CZ
Carbomedac, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji
DE/H/0803/001 17440 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
PL
Carbomedac, koncentrat til infusionsvæske, opløsning
DE/H/0803/001 43706 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
DK
List of nationally authorised medicinal products EMA/753864/2016 Page 3/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DE/H/0803/001 39079.02.00 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
DE
CARBOPLAN® not available 27/01/2095 VIANEX S.A. GR CARBOPLAN® not available 82820 VIANEX S.A. GR CARBOPLAN® not available 82806 VIANEX S.A. GR Carboplat onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 86165.00.00 ONKOVIS GMBH DE
Carboplatin 450 mg/45ml Concentrate for Solution for Infusion
not available PL 36390/0193 CIPLA (EU) LIMITED UK
Carboplatin 50 mg/5ml Concentrate for Solution for Infusion
not available PL 36390/0191 CIPLA (EU) LIMITED UK
Carboplatin "Ebewe" NOT APPLICABLE 36002 EBEWE PHARMA DK Carboplatin "Ebewe" NOT APPLICABLE 244999 EBEWE PHARMA EE Carboplatin "Ebewe" 10 mg/ml - Konzentrat zur Infusionsbereitung
936.660 1-22395 EBEWE PHARMA AT
Carboplatin "Ebewe" 10 mg/ml - Konzentrat zur Infusionsbereitung
936.660 1-22395 EBEWE PHARMA AT
CARBOPLATIN "EBEWE" 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
NL/H/3556/001 05-0604 EBEWE PHARMA LV
Carboplatin "Ebewe" 10 mg/ml koncentrátum oldatos infúzióhoz
OGYI-T-6677/01 OGYI-T-6677/02 OGYI-T-6677/03
EBEWE PHARMA HU
Carboplatin "Hospira" not available 14080 HOSPIRA NORDIC AB DK Carboplatin "Pfizer", koncentrat til infusionsvæske, opløsning
not available 15534 PFIZER APS DK
List of nationally authorised medicinal products EMA/753864/2016 Page 4/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
UK/H/1126/001 41344 ACCORD HEALTHCARE LIMITED
DK
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
UK/H/1126/001 41344 ACCORD HEALTHCARE LIMITED
DK
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
UK/H/1126/001 41344 ACCORD HEALTHCARE LIMITED
DK
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
UK/H/1126/001 41344 ACCORD HEALTHCARE LIMITED
DK
Carboplatin ”Actavis”, koncentrat til infusionsvæske, opløsning
DE/H/1222/001 43174 ACTAVIS GROUP PTC EHF. DK
Carboplatin ”Fresenius Kabi”, koncentrat til infusionsvæske, opløsning
UK/H/4181/001 48062 FRESENIUS KABI ONCOLOGY PLC.
DK
Carboplatin ”Fresenius Kabi”, koncentrat til infusionsvæske, opløsning
UK/H/4181/001 48062 FRESENIUS KABI ONCOLOGY PLC.
DK
Carboplatin ”Mylan”, koncentrat til infusionsvæske
NO/H/0179/001 46233 MYLAN HOSPITAL AS DK
Carboplatin „Pfizer“ 10 mg/ml innrennslisþykkni, lausn
not available 930044 (IS) PFIZER APS IS
Carboplatin 10 mg/ml Concentrate for Infusion
UK/H/0273/001 PL 00289/0847 TEVA UK LIMITED UK
Carboplatin 10 mg/ml concentrate for solution for infusion
not available S00781 ACCORD HEALTHCARE LIMITED
CY
Carboplatin 10 mg/ml concentrate for solution for infusion
not available S00781 ACCORD HEALTHCARE LIMITED
CY
List of nationally authorised medicinal products EMA/753864/2016 Page 5/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin 10 mg/ml concentrate for solution for infusion
not available S00781 ACCORD HEALTHCARE LIMITED
CY
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
UK/H/1126/001 PA1390/6/1 ACCORD HEALTHCARE LIMITED
IE
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
UK/H/1126/001 PA1390/6/1 ACCORD HEALTHCARE LIMITED
IE
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
UK/H/1126/001 PA1390/6/1 ACCORD HEALTHCARE LIMITED
IE
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
UK/H/1126/001 PA1390/6/1 ACCORD HEALTHCARE LIMITED
IE
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 PA 1422/008/001 FRESENIUS KABI ONCOLOGY PLC.
IE
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 PA 1422/008/001 FRESENIUS KABI ONCOLOGY PLC.
IE
Carboplatin 10 mg/ml concentrate for solution for infusion
not available AA054/06401 ACCORD HEALTHCARE LIMITED
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
not available AA054/06401 ACCORD HEALTHCARE LIMITED
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
not available AA054/06401 ACCORD HEALTHCARE LIMITED
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00301 FRESENIUS KABI ONCOLOGY PLC.
MT
List of nationally authorised medicinal products EMA/753864/2016 Page 6/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00303 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00304 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00302 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00301 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00303 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00304 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 MA 911/00302 FRESENIUS KABI ONCOLOGY PLC.
MT
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/1370/001 PL 31750/0001 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
UK
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/1126/001 PL 20075/0028 ACCORD HEALTHCARE LIMITED
UK
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/1126/001 PL 20075/0028 ACCORD HEALTHCARE LIMITED
UK
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/1126/001 PL 20075/0028 ACCORD HEALTHCARE LIMITED
UK
List of nationally authorised medicinal products EMA/753864/2016 Page 7/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/1126/001 PL 20075/0028 ACCORD HEALTHCARE LIMITED
UK
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 PL 18727/0025 FRESENIUS KABI ONCOLOGY PLC.
UK
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
not available PL 20417/0011 FANNIN LTD UK
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
not available PL 20417/0012 FANNIN LTD UK
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
not available PL 20417/0013 FANNIN LTD UK
Carboplatin 10 mg/ml concentrate for solution for infusion
UK/H/4181/001 PL 18727/0025 FRESENIUS KABI ONCOLOGY PLC.
UK
Carboplatin 10 mg/ml Intravenous Infusion
not available 27/01/1933 PHARMACEUTICAL TRADING CO LTD
CY
Carboplatin 10 mg/ml Intravenous Infusion
not available AA 157/00202 HOSPIRA UK LTD MT
Carboplatin 10 mg/ml Intravenous Infusion
not available PL 04515/0050 HOSPIRA UK LTD UK
CARBOPLATIN 10 mg/ml Concentrate For Solution For Infusion Carboplatino Pharmacia 10 mg/ml concentrado para solucion para perfusion EFG
62123 Pharmacia Nostrum, S.A.
ES
List of nationally authorised medicinal products EMA/753864/2016 Page 8/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATIN 10 mg/ml Concentrate For Solution For Infusion Carboplatin
04-0138 Pfizer Europe MA EEIG, United Kingdom
LV
Carboplatin 10mg/ml Concentrate for Solution for Infusion
not available PA 0437/017/002A HOSPIRA UK LTD IE
Carboplatin 10mg/ml Concentrate for Solution for Injection
PL 14510/0014 PL 14510/0014 EBEWE PHARMA UK
Carboplatin 10mg/ml Concentrate for Solution for Injection
PL 14510/0015 PL 14510/0015 EBEWE PHARMA UK
Carboplatin 10mg/ml Concentrate for Solution for Injection
PL 14510/0016 PL 14510/0016 EBEWE PHARMA UK
Carboplatin 150 mg/15ml Concentrate for Solution for Infusion
not available PL 36390/0192 CIPLA (EU) LIMITED UK
Carboplatin 600 mg HEXAL® 2153601 53601.00.00 HEXAL AG DE Carboplatin Accord 10 mg/ml infuusiokonsentraatti, liuosta varten
UK/H/1126/001 23562 ACCORD HEALTHCARE LIMITED
FI
Carboplatin Accord 10 mg/ml infuusiokonsentraatti, liuosta varten
UK/H/1126/001 23562 ACCORD HEALTHCARE LIMITED
FI
Carboplatin Accord 10 mg/ml infuusiokonsentraatti, liuosta varten
UK/H/1126/001 23562 ACCORD HEALTHCARE LIMITED
FI
Carboplatin Accord 10 mg/ml infuusiokonsentraatti, liuosta varten
UK/H/1126/001 23562 ACCORD HEALTHCARE LIMITED
FI
Carboplatin Accord 10 mg/ml infúzny koncentrát
UK/H/1126/001 44/0595/10-S ACCORD HEALTHCARE LIMITED
SK
List of nationally authorised medicinal products EMA/753864/2016 Page 9/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Accord 10 mg/ml infúzny koncentrát
UK/H/1126/001 44/0595/10-S ACCORD HEALTHCARE LIMITED
SK
Carboplatin Accord 10 mg/ml infúzny koncentrát
UK/H/1126/001 44/0595/10-S ACCORD HEALTHCARE LIMITED
SK
Carboplatin Accord 10 mg/ml infúzny koncentrát
UK/H/1126/001 44/0595/10-S ACCORD HEALTHCARE LIMITED
SK
Carboplatin Accord 10 mg/ml koncentrát pro prípravu infuzního roztoku
UK/H/1126/001 44/292/09-C ACCORD HEALTHCARE LIMITED
CZ
Carboplatin Accord 10 mg/ml koncentrát pro přípravu infuzního roztoku
UK/H/1126/001 44/292/09-C ACCORD HEALTHCARE LIMITED
CZ
Carboplatin Accord 10 mg/ml koncentrát pro přípravu infuzního roztoku
UK/H/1126/001 44/292/09-C ACCORD HEALTHCARE LIMITED
CZ
Carboplatin Accord 10 mg/ml koncentrát pro přípravu infuzního roztoku
UK/H/1126/001 44/292/09-C ACCORD HEALTHCARE LIMITED
CZ
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
UK/H/1126/001 25512 ACCORD HEALTHCARE LIMITED
SE
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
UK/H/1126/001 25512 ACCORD HEALTHCARE LIMITED
SE
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
UK/H/1126/001 25512 ACCORD HEALTHCARE LIMITED
SE
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
UK/H/1126/001 25512 ACCORD HEALTHCARE LIMITED
SE
Carboplatin Accord 10 mg/ml koncentratas infuziniam tirpalui
UK/H/1126/001 LT/1/09/1811/001 ACCORD HEALTHCARE LIMITED
LT
Carboplatin Accord 10 mg/ml koncentratas infuziniam tirpalui
UK/H/1126/001 LT/1/09/1811/002 ACCORD HEALTHCARE LIMITED
LT
List of nationally authorised medicinal products EMA/753864/2016 Page 10/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Accord 10 mg/ml koncentratas infuziniam tirpalui
UK/H/1126/001 LT/1/09/1811/003 ACCORD HEALTHCARE LIMITED
LT
Carboplatin Accord 10 mg/ml koncentratas infuziniam tirpalui
UK/H/1126/001 LT/1/09/1811/004 ACCORD HEALTHCARE LIMITED
LT
Carboplatin Accord 10 mg/ml koncentrats infuziju škiduma pagatavošanai
UK/H/1126/01/DC 09-0483-5 ACCORD HEALTHCARE LIMITED
LV
Carboplatin Accord 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
UK/H/1126/001 09-0483-5 ACCORD HEALTHCARE LIMITED
LV
Carboplatin Accord 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
UK/H/1126/01/DC 09-0483-5 ACCORD HEALTHCARE LIMITED
LV
Carboplatin Accord 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
UK/H/1126/01/DC 09-0483-5 ACCORD HEALTHCARE LIMITED
LV
Carboplatin Accord 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/1126/001 OGYI-T-21544/01 ACCORD HEALTHCARE LIMITED
HU
Carboplatin Accord 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/1126/001 OGYI-T-21544/02 ACCORD HEALTHCARE LIMITED
HU
Carboplatin Accord 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/1126/001 OGYI-T-21544/03 ACCORD HEALTHCARE LIMITED
HU
Carboplatin Accord 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/1126/001 OGYI-T-21544/04 ACCORD HEALTHCARE LIMITED
HU
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/1126/01/DC 07-4965 ACCORD HEALTHCARE LIMITED
NO
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/1126/01/DC 07-4965 ACCORD HEALTHCARE LIMITED
NO
List of nationally authorised medicinal products EMA/753864/2016 Page 11/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/1126/01/DC 07-4965 ACCORD HEALTHCARE LIMITED
NO
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/1126/01/DC 07-4965 ACCORD HEALTHCARE LIMITED
NO
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 1-29688 ACCORD HEALTHCARE LIMITED
AT
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 1-29688 ACCORD HEALTHCARE LIMITED
AT
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 1-29688 ACCORD HEALTHCARE LIMITED
AT
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 1-29688 ACCORD HEALTHCARE LIMITED
AT
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 69496.00.00 ACCORD HEALTHCARE LIMITED
DE
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 69496.00.00 ACCORD HEALTHCARE LIMITED
DE
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 69496.00.00 ACCORD HEALTHCARE LIMITED
DE
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1126/001 69496.00.00 ACCORD HEALTHCARE LIMITED
DE
Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 RVG 100101 ACCORD HEALTHCARE LIMITED
NL
List of nationally authorised medicinal products EMA/753864/2016 Page 12/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 RVG 100101 ACCORD HEALTHCARE LIMITED
NL
Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 RVG 100101 ACCORD HEALTHCARE LIMITED
NL
Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 RVG 100101 ACCORD HEALTHCARE LIMITED
NL
Carboplatin Accord Healthcare 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 BE 421811 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 BE 340401 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 BE 340417 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, concentraat voor oplossing voor infusie
UK/H/1126/001 BE 340392 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, solution à diluer pour perfusion
UK/H/1126/001 BE 421811 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, solution à diluer pour perfusion
UK/H/1126/001 BE 340401 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, solution à diluer pour perfusion
UK/H/1126/001 BE 340417 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord Healthcare 10 mg/ml, solution à diluer pour perfusion
UK/H/1126/001 BE 340392 ACCORD HEALTHCARE LIMITED
BE
Carboplatin Accord, 10 mg/ml infusioonilahuse kontsentraat
UK/H/1126/001 627909 ACCORD HEALTHCARE LIMITED
EE
List of nationally authorised medicinal products EMA/753864/2016 Page 13/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Accord, 10 mg/ml infusioonilahuse kontsentraat
UK/H/1126/001 627909 ACCORD HEALTHCARE LIMITED
EE
Carboplatin Accord, 10 mg/ml infusioonilahuse kontsentraat
UK/H/1126/001 627909 ACCORD HEALTHCARE LIMITED
EE
Carboplatin Accord, 10 mg/ml infusioonilahuse kontsentraat
UK/H/1126/001 627909 ACCORD HEALTHCARE LIMITED
EE
Carboplatin Accord, 10 mg/ml, koncentrat do sporzadzania roztworu do infuzji
UK/H/1126/001 16711 ACCORD HEALTHCARE LIMITED
PL
Carboplatin Accord, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji
UK/H/1126/001 16711 ACCORD HEALTHCARE LIMITED
PL
Carboplatin Accord, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji
UK/H/1126/001 16711 ACCORD HEALTHCARE LIMITED
PL
Carboplatin Accord, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji
UK/H/1126/001 16711 ACCORD HEALTHCARE LIMITED
PL
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 20100308 ACTAVIS GROUP PTC EHF. BG
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 668410 ACTAVIS GROUP PTC EHF. EE
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 IS/1/08/075/01 ACTAVIS GROUP PTC EHF. IS
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 10-0062 ACTAVIS GROUP PTC EHF. LV
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 08-5853 ACTAVIS GROUP PTC EHF. NO
List of nationally authorised medicinal products EMA/753864/2016 Page 14/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001 16902 ACTAVIS GROUP PTC EHF. PL
Carboplatin Actavis 10 mg/ml concentrate for solution for infusion
DE/H/1222/001/DC 26883 ACTAVIS GROUP PTC EHF. SE
Carboplatin Actavis 10 mg/ml infuusiokonsentraatti, liuosta varten
DE/H/1222/001 24983 ACTAVIS GROUP PTC EHF. FI
Carboplatin Actavis 10 mg/ml koncentratas infuziniam tirpalui
DE/H/1222/001 LT/1/10/1950/001-005 ACTAVIS GROUP PTC EHF. LT
Carboplatin Actavis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 1-27399 ACTAVIS GROUP PTC EHF. AT
Carboplatin Actavis 10mg/ml concentrat pentru solutie perfuzabilaa
111/2007/01-02-03-04
111/2007/01-02-03-04 ACTAVIS SRL RO
Carboplatin Cipla 50 mg/5ml concentraat voor oplossing voor infusie
SE/H/1425/001 BE482302 CIPLA EUROPE NV BE
Carboplatin Cipla 10 mg/ml concentrate for solution for infusion
SE/H/1425/001 PA1963/008/001 CIPLA EUROPE NV IE
Carboplatin Cipla 10 mg/ml concentrate for solution for infusion
SE/H/1425/001/DC MA 1059/00501 MA 1059/00503 MA 1059/00504
CIPLA EUROPE NV MT
Carboplatin Cipla 10 mg/ml koncentrat till infusionsvätska, lösning
SE/H/1425/001 51008 CIPLA EUROPE NV SE
Carboplatin Cipla 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
SE/H/1425/001 136637 CIPLA EUROPE NV AT
Carboplatin Cipla 150 mg/15ml concentraat voor oplossing voor infusie
SE/H/1425/001 BE482311 CIPLA EUROPE NV BE
List of nationally authorised medicinal products EMA/753864/2016 Page 15/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Cipla 450 mg/45ml concentraat voor oplossing voor infusie
SE/H/1425/001 BE482320 CIPLA EUROPE NV BE
Carboplatin Cipla 600mg/60ml concentraat voor oplossing voor infusie
SE/H/1425/001 BE482337 CIPLA EUROPE NV BE
Carboplatin Cipla I0 mg/ml concerat pentru solutie perfuzabila
SE/H/1425/001 8402/2015/01 CIPLA EUROPE NV RO
Carboplatin Cipla I0 mg/ml concerat pentru solutie perfuzabila
SE/H/1425/001 8402/2015/02 CIPLA EUROPE NV RO
Carboplatin Cipla I0 mg/ml concerat pentru solutie perfuzabila
SE/H/1425/001 8402/2015/03 CIPLA EUROPE NV RO
Carboplatin Cipla I0 mg/ml concerat pentru solutie perfuzabila
SE/H/1425/001 8402/2015/04 CIPLA EUROPE NV RO
Carboplatin Ebewe 10 mg/ml concentrat pentru soluţie perfuzabilă
NOT APPLICABLE 7000/2006/03 EBEWE PHARMA RO
Carboplatin Ebewe 10 mg/ml concentrat pentru soluţie perfuzabilă
NOT APPLICABLE 7000/2006/01 EBEWE PHARMA RO
Carboplatin Ebewe 10 mg/ml concentrat pentru soluţie perfuzabilă
NOT APPLICABLE 7000/2006/02 EBEWE PHARMA RO
Carboplatin Ebewe 10 mg/ml infuusiokonsentraatti, liuosta varten
NOT APPLICABLE 13365 EBEWE PHARMA FI
Carboplatin Ebewe 10 mg/ml koncentrat till infusionsvätska, lösning
1997-0598 14126 EBEWE PHARMA SE
List of nationally authorised medicinal products EMA/753864/2016 Page 16/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/006 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/007 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/001 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/002 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/003 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/004 EBEWE PHARMA SI
Carboplatin Ebewe 10 mg/ml koncentrat za raztopino za infundiranje
NL/H/3556/001 H/05/00339/005 EBEWE PHARMA SI
Carboplatin EBEWE 10 mg/ml koncentratas infuziniam tirpalui
NOT APPLICABLE LT/1/96/3139/002 EBEWE PHARMA LT
Carboplatin EBEWE 10 mg/ml koncentratas infuziniam tirpalui
NOT APPLICABLE LT/1/96/3139/001 EBEWE PHARMA LT
Carboplatin Ebewe 10 mg/ml konsentrat til infusjonsvæske
NL/H/3556/001 05-3427 EBEWE PHARMA NO
Carboplatin Fresenius Kabi 10 mg/ml innrennslisþykkni, lausn
UK/H/4181/001 IS/1/12/025/01 FRESENIUS KABI ONCOLOGY PLC.
IS
Carboplatin Fresenius Kabi 10 mg/ml innrennslisþykkni, lausn
UK/H/4181/001 IS/1/12/025/01 FRESENIUS KABI ONCOLOGY PLC.
IS
Carboplatin Fresenius Kabi 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/4181/001 10-8046 FRESENIUS KABI ONCOLOGY PLC.
NO
List of nationally authorised medicinal products EMA/753864/2016 Page 17/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Fresenius Kabi 10 mg/ml konsentrat til infusjonsvæske, oppløsning
UK/H/4181/001 10-8046 FRESENIUS KABI ONCOLOGY PLC.
NO
Carboplatin HAEMATO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 51003.00.00 HAEMATO PHARM GMBH DE
Carboplatin Hexal 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DE/H/1223/001 70328.00.00 HEXAL AG DE
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 49694.00.00 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
DE
Carboplatin Hospira 10 mg/ml infuusiokonsentraatti, liuosta varten
DE/H/0365/001 17614 HOSPIRA UK LTD FI
Carboplatin Hospira 10 mg/ml innrennslisþykkni, lausn
not available 910046 HOSPIRA NORDIC AB IS
Carboplatin Hospira 10 mg/ml koncentrát pro infuzní roztok
not available 44/260/99-C HOSPIRA UK LTD CZ
Carboplatin Hospira 10 mg/ml konsentrat til infusjonsvæske
not available 7681 HOSPIRA NORDIC AB NO
Carboplatin Hospira 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DE/H/0365/001 39195.00.00 HOSPIRA DEUTSCHLAND GMBH
DE
Carboplatin Hospira 10 mg/ml, koncentrat till infusionsvätska, lösning
DE/H/0365/001 17614 HOSPIRA UK LTD FI
Carboplatin Hospira 10 mg/ml, koncentrat till infusionsvätska, lösning
DE/H/0365/001 18742 HOSPIRA UK LTD SE
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/02 FRESENIUS KABI ONCOLOGY PLC.
RO
List of nationally authorised medicinal products EMA/753864/2016 Page 18/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/03 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/04 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/01 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/02 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/03 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/04 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml concentrat pentru soluţie perfuzabilă
UK/H/4181/001 4711/2012/01 FRESENIUS KABI ONCOLOGY PLC.
RO
Carboplatin Kabi 10 mg/ml infúzny koncentrát
UK/H/4181/001 44/0165/12-S FRESENIUS KABI ONCOLOGY PLC.
SK
Carboplatin Kabi 10 mg/ml infúzny koncentrát
UK/H/4181/001 44/0165/12-S FRESENIUS KABI ONCOLOGY PLC.
SK
Carboplatin Kabi 10 mg/ml koncentrát pro infuzní roztok
UK/H/4181/001 44/296/12-C FRESENIUS KABI ONCOLOGY PLC.
CZ
Carboplatin Kabi 10 mg/ml koncentrát pro infuzní roztok
UK/H/4181/001 44/296/12-C FRESENIUS KABI ONCOLOGY PLC.
CZ
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/002 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/003 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/004 FRESENIUS KABI ONCOLOGY PLC.
LT
List of nationally authorised medicinal products EMA/753864/2016 Page 19/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/001 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/002 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/003 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/004 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentratas infuziniam tirpalui
UK/H/4181/001 LT/1/12/2880/001 FRESENIUS KABI ONCOLOGY PLC.
LT
Carboplatin Kabi 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
UK/H/4181/001 12-0048 FRESENIUS KABI ONCOLOGY PLC.
LV
Carboplatin Kabi 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
UK/H/4181/001 12-0048 FRESENIUS KABI ONCOLOGY PLC.
LV
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/01-02-03-04-05-06-07-08-09-10-11-12-13-14-15-16
FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/02 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/03 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/04 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/01 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/02 FRESENIUS KABI ONCOLOGY PLC.
HU
List of nationally authorised medicinal products EMA/753864/2016 Page 20/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/03 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/04 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml koncentrátum oldatos infúzióhoz
UK/H/4181/001 OGYI-T-22216/01 FRESENIUS KABI ONCOLOGY PLC.
HU
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 84223.00.00 FRESENIUS KABI ONCOLOGY PLC.
DE
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 84223.00.00 FRESENIUS KABI ONCOLOGY PLC.
DE
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 2013010008 FRESENIUS KABI ONCOLOGY PLC.
LU
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 2013010008 FRESENIUS KABI ONCOLOGY PLC.
LU
Carboplatin Kabi 10 mg/ml, infusioonilahuse kontsentraat
UK/H/4181/001 777812 FRESENIUS KABI ONCOLOGY PLC.
EE
Carboplatin Kabi 10 mg/ml, infusioonilahuse kontsentraat
UK/H/4181/001 777812 FRESENIUS KABI ONCOLOGY PLC.
EE
Carboplatin Kabi, lO mg/ml, koncentrat do sporządzania roztworu do infuzji
UK/H/4181/001 20392 FRESENIUS KABI ONCOLOGY PLC.
PL
Carboplatin Kabi, lO mg/ml, koncentrat do sporządzania roztworu do infuzji
UK/H/4181/001 20392 FRESENIUS KABI ONCOLOGY PLC.
PL
Carboplatin Mylan 10 mg/ml infuusiokonsentraatti, liuosta varten
NO/H/0179/001 28384 MYLAN HOSPITAL AS FI
List of nationally authorised medicinal products EMA/753864/2016 Page 21/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Mylan 10 mg/ml innrennslisþykkni, lausn
NO/H/0179/001 IS/1/10/059/01 MYLAN HOSPITAL AS IS
Carboplatin Mylan 10 mg/ml koncentrat till infusionsvätska, lösning
NO/H/0179/001 43555 MYLAN HOSPITAL AS SE
Carboplatin Mylan 10 mg/ml konsentrat til infusjonsvæske, oppløsning
NO/H/0179/001 09-7275 MYLAN HOSPITAL AS NO
Carboplatin OMNICARE 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 85112.00.00 OMNICARE PHARMA GMBH DE
Carboplatin onkovis 10 mg/ml Infusionslösung
not available 39079.00.00 ONKOVIS GMBH DE
Carboplatin Pfizer N/A 411903 Pfizer Enterprises ET Carboplatin Pfizer CS 150 mg Konzentrat zur Infusionsbereitung
not available 1-21070 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Carboplatin Pfizer CS 450 mg Konzentrat zur Infusionsbereitung
not available 1-21069 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
CARBOPLATIN Pfizer koncentrat za otopinu za infuziju 150 mg/ 15 ml
not available UP/I-530-09/05-02/968 PFIZER CROATIA D.O.O. HR
Carboplatin Pfizer, 10 mg/ml, roztwór do wstrzykiwań
not available 4774 PFIZER EUROPE MA EEIG PL
CARBOPLATIN PLIVA 10mg/ml koncentrat za raztopino za infundiranje
not available 5363-I-1660/12 PLIVA LJUBLJANA D.O.O.; SI
CARBOPLATIN PLIVA 10mg/ml koncentrat za raztopino za infundiranje
not available 5363-I-1661/12 PLIVA LJUBLJANA D.O.O.; SI
CARBOPLATIN PLIVA 10mg/ml koncentrat za raztopino za infundiranje
not available 5363-I-1662/12 PLIVA LJUBLJANA D.O.O.; SI
List of nationally authorised medicinal products EMA/753864/2016 Page 22/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin Pliva 150 mg/15 ml koncentrat za otopinu za infuziju
not available UP/I-530-09/12-02/236 PLIVA HRVATSKA D.O.O. HR
Carboplatin Pliva 50 mg/5 ml koncentrat za otopinu za infuziju
not available UP/I-530-09/12-02/235 PLIVA HRVATSKA D.O.O. HR
Carboplatin Profusio 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
not available 70331.00.00 PGD PROFUSIO LEIPZIG GESUNDHEITS GMBH DEUTSCHLAND
DE
Carboplatin Sandoz 10 mg/ml concentraat voor oplossing voor infusie
NL/H/3556/001 BE384702 SANDOZ N.V. BE
Carboplatin Sandoz 10 mg/ml concentraat voor oplossing voor infusie
NL/H/3556/001 BE363876 SANDOZ N.V. BE
Carboplatin Sandoz 10 mg/ml concentraat voor oplossing voor infusie
NL/H/3556/001 BE384711 SANDOZ N.V. BE
Carboplatin Sandoz 10 mg/ml concentraat voor oplossing voor infusie
NL/H/3556/001 BE363867 SANDOZ N.V. BE
Carboplatin Sandoz 10 mg/ml concentraat voor oplossing voor infusie
NL/H/3556/001 BE363885 SANDOZ N.V. BE
Carboplatin SUN 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/1370/001 72723.00.00 SUN PHARMACEUTICALS GERMANY GMBH
DE
Carboplatin Teva 10 mg/ml koncentrat till infusionsvätska, lösning
not available 12452 TEVA SWEDEN AB SE
CARBOPLATIN/ MEDICUS® not available 26230/14/18-09-2015 MEDICUS A.E GR CARBOPLATIN/HOSPIRA 450 mg/45ml Onco-Tain
not available 46576/29-07-2015 HOSPIRA UK LTD GR
List of nationally authorised medicinal products EMA/753864/2016 Page 23/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATIN/HOSPIRA Διάλυμα για ενδοφλέβια έγχυση: - 150MG/15ML
not available 79163/26-09-2014 HOSPIRA UK LTD GR
CARBOPLATIN/HOSPIRA Διάλυμα για ενδοφλέβια έγχυση: - 450MG/45ML
not available 84876/26-09-2014 HOSPIRA UK LTD GR
CARBOPLATIN/HOSPIRA Διάλυμα για ενδοφλέβια έγχυση:- 150MG/15ML
not available 11922/29-07-2015 HOSPIRA UK LTD GR
CARBOPLATIN/MEDICUS 10MG/1ML
not available 44355/18-6-2009 MEDICUS A.E GR
CARBOPLATIN/NEXUS not available 74030/13/04-12-2014 NEXUS MEDICALS S.A. GR Carboplatina Accord 10 mg/ml concentrado para solução para perfusão
UK/H/1126/001 5210158 ACCORD HEALTHCARE LIMITED
PT
Carboplatina Accord 10 mg/ml concentrado para solução para perfusão
UK/H/1126/001 5210166 ACCORD HEALTHCARE LIMITED
PT
Carboplatina Accord 10 mg/ml concentrado para solução para perfusão
UK/H/1126/001 5210174 ACCORD HEALTHCARE LIMITED
PT
Carboplatina Accord 10 mg/ml concentrado para solução para perfusão
UK/H/1126/001 5422449 ACCORD HEALTHCARE LIMITED
PT
Carboplatina APS 10 mg/ml solução para perfusão
not available 2913788 GENERIS FARMACÊUTICA, S.A.
PT
Carboplatina APS 10 mg/ml solução para perfusão
not available 2913887 GENERIS FARMACÊUTICA, S.A.
PT
Carboplatina APS 10 mg/ml solução para perfusão
not available 3420080 GENERIS FARMACÊUTICA, S.A.
PT
Carboplatina APS 10 mg/ml solução para perfusão
not available 2913986 GENERIS FARMACÊUTICA, S.A.
PT
Carboplatina Hikma, 10 mg/ml, Solução para perfusão
not available 5458534 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
PT
List of nationally authorised medicinal products EMA/753864/2016 Page 24/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatina Hikma, 10 mg/ml, Solução para perfusão
not available 5458542 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
PT
Carboplatina Hikma, 10 mg/ml, Solução para perfusão
not available 5458559 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443874 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443908 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443916 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443866 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443874 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443908 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443916 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Kabi 10 mg/ml concentrado para solução para perfusão
UK/H/4181/001 5443866 FRESENIUS KABI ONCOLOGY PLC.
PT
Carboplatina Sandoz NOT APPLICABLE 5181540 SANDOZ FARMACÊUTICA LDA.
PT
Carboplatina Sandoz NOT APPLICABLE 5181532 SANDOZ FARMACÊUTICA LDA.
PT
Carboplatina Sandoz NOT APPLICABLE 5181565 SANDOZ FARMACÊUTICA LDA.
PT
List of nationally authorised medicinal products EMA/753864/2016 Page 25/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatina Sandoz NOT APPLICABLE 5181557 SANDOZ FARMACÊUTICA LDA.
PT
Carboplatina Teva 10 mg/ml Solução Injectável
not available 5883582 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Carboplatina Teva 10 mg/ml Solução Injectável
not available 2663185 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Carboplatina Teva 10 mg/ml Solução Injectável
not available 2663086 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Carboplatina Teva 10 mg/ml Solução Injectável
not available 2662989 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA
PT
Carboplatin-Actavis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DE/H/1222/001 70327.00.00 ACTAVIS GROUP PTC EHF. DE
CARBOPLATINE ARROW 10 mg/ml, solution pour perfusion
not available NL 34163 ARROW GENERIQUES FR
Carboplatine Aurobindo 10 mg/ml, concentraat voor oplossing voor infusie
DE/H/1222/001 RVG 102451 AUROBINDO PHARMA B.V. NL
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
List of nationally authorised medicinal products EMA/753864/2016 Page 26/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 RVG 108902 FRESENIUS KABI ONCOLOGY PLC.
NL
Carboplatine Fresenius Kabi 10 mg/ml concentraat voor oplossing voor infusie
UK/H/4181/001 RVG 108902 FRESENIUS KABI ONCOLOGY PLC.
NL
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
List of nationally authorised medicinal products EMA/753864/2016 Page 27/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419501 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419517 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419526 FRESENIUS KABI ONCOLOGY PLC.
BE
List of nationally authorised medicinal products EMA/753864/2016 Page 28/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatine Fresenius Kabi 10 mg/ml solution à diluer pour perfusion
UK/H/4181/001 BE419492 FRESENIUS KABI ONCOLOGY PLC.
BE
Carboplatine Hospira 10 mg/ml Onco-Tain concentraat voor oplossing voor infusie 10 mg/ml, 50 mg, 150 mg en 450 mg
not available RVG 23321 HOSPIRA BENELUX BVBA NL
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 570 801-1 OR 34009 570 801 1 2
HOSPIRA FRANCE FR
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 570 802-8 OR 34009 570 802 8 0
HOSPIRA FRANCE FR
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 570 803-4 OU 34009 570 803 4 1
HOSPIRA FRANCE FR
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 570 804-0 OU 34009 570 804 0 2
HOSPIRA FRANCE FR
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 563 174-5 OR 34009 563 174 5 5
HOSPIRA FRANCE FR
CARBOPLATINE HOSPIRA 10 mg/ml, solution injectable pour perfusion
not available 563 175-1 OR 34009 563 175 1 6
HOSPIRA FRANCE FR
Carboplatine Hospira 150 mg/15 ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available BE 165986 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 150 mg/15 ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available 1447/94100664 0492875 HOSPIRA BENELUX BVBA LU
List of nationally authorised medicinal products EMA/753864/2016 Page 29/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatine Hospira 150 mg/15 ml Onco-Tain oplossing voor intraveneuze injectie of intraveneuze infusie
not available BE 165986 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 150 mg/15 ml Onco-Tain solution pour injection intraveineuse ou infusion intraveineuse
not available BE 165986 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 150 mg/15 ml Onco-Tain solution pour injection IV ou infusion IV
not available 1447/94100664 0492875 HOSPIRA BENELUX BVBA LU
Carboplatine Hospira 450 mg/45 ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available BE 165977 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 450 mg/45 ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available 1447/94100665 0492889 HOSPIRA BENELUX BVBA LU
Carboplatine Hospira 450 mg/45 ml Onco-Tain oplossing voor intraveneuze injectie of intraveneuze infusie
not available BE 165977 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 450 mg/45 ml Onco-Tain solution pour injection intraveineuse ou infusion intraveineuse
not available BE 165977 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 450 mg/45 ml Onco-Tain solution pour injection IV ou infusion IV
not available 1447/94100665 0492889 HOSPIRA BENELUX BVBA LU
Carboplatine Hospira 600 mg/60 ml concentraat voor oplossing voor infusie 10 mg/ml
not available RVG 26203 HOSPIRA BENELUX BVBA NL
List of nationally authorised medicinal products EMA/753864/2016 Page 30/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatine Hospira 600 mg/60 ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available BE 165995 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 600 mg/60 ml Onco-Tain oplossing voor intraveneuze injectie of intraveneuze infusie
not available BE 165995 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 600 mg/60 ml Onco-Tain solution pour injection intraveineuse ou infusion intraveineuse
not available BE 165995 HOSPIRA BENELUX BVBA BE
Carboplatine Hospira 600 mg/60 ml Onco-Tain solution pour injection IV ou infusion IV
not available 1447/94100663 0492861 HOSPIRA BENELUX BVBA LU
Carboplatine Hospira 600mg/60ml Onco-Tain Lösung zur intravenösen Injektion oder Infusion
not available 1447/94100663 0492861 HOSPIRA BENELUX BVBA LU
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 862 4 4 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 860 1 5 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 861 8 3 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 863 0 5 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 862 4 4 FRESENIUS KABI ONCOLOGY PLC.
FR
List of nationally authorised medicinal products EMA/753864/2016 Page 31/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 860 1 5 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 861 8 3 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
UK/H/4181/001 34009 583 863 0 5 FRESENIUS KABI ONCOLOGY PLC.
FR
CARBOPLATINE MYLAN 10 mg/ml, solution pour perfusion
not available NL 23 840 MYLAN S.A.S FR
Carboplatine Sandoz 10 mg/ml - concentraat voor oplossing voor infusie
NL/H/3556/001 RVG 32455 SANDOZ B.V. NL
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 564 134-7 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 564 135-3 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 012-2 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 564 137-6 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 409-0 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 015-1 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 016-8 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 410-9 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 017-4 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 412-1 SANDOZ FR
List of nationally authorised medicinal products EMA/753864/2016 Page 32/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 413-8 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 414-4 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 013-9 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 565 014-5 SANDOZ FR
CARBOPLATINE SANDOZ 10 mg/ml, solution pour perfusion
NL 28536 581 411-5 SANDOZ FR
Carboplatine SUN 10 mg/ml concentraat voor oplossing voor infusie
UK/H/1370/001 RVG 101867 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
NL
Carboplatine SUN 10 mg/ml, solution à diluer pour perfusion
UK/H/1370/001 34009 576 965 6 6 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
FR
Carboplatine SUN 10 mg/ml, solution à diluer pour perfusion
UK/H/1370/001 34009 576 968 5 6 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
FR
Carboplatine SUN 10 mg/ml, solution à diluer pour perfusion
UK/H/1370/001 34009 576 972 2 8 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
FR
Carboplatine SUN 10 mg/ml, solution à diluer pour perfusion
UK/H/1370/001 34009 576 961 0 8 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
FR
CARBOPLATINE TEVA 10 mg/ml, solution pour perfusion
not available NL23774 TEVA SANTÉ FR
CARBOPLATIN-EBEWE, 10 MG/ML, KONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI
4500 4500 EBEWE PHARMA PL
Carboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
UK/H/0273/001 44922.00.00 TEVA GMBH DE
CARBOPLATINO ACCORD 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
UK/H/1126/001 70707 ACCORD HEALTHCARE S.L.U.
ES
List of nationally authorised medicinal products EMA/753864/2016 Page 33/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATINO ACCORD 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
UK/H/1126/001 70707 ACCORD HEALTHCARE S.L.U.
ES
CARBOPLATINO ACCORD 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
UK/H/1126/001 70707 ACCORD HEALTHCARE S.L.U.
ES
CARBOPLATINO ACCORD 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG
UK/H/1126/001 70707 ACCORD HEALTHCARE S.L.U.
ES
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
UK/H/1126/001 039263013/M ACCORD HEALTHCARE LIMITED
IT
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
UK/H/1126/001 039263025/M ACCORD HEALTHCARE LIMITED
IT
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
UK/H/1126/001 039263037/M ACCORD HEALTHCARE LIMITED
IT
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
UK/H/1126/001 039263049/M ACCORD HEALTHCARE LIMITED
IT
CARBOPLATINO AUROBINDO 10 mg/ml concentrato per soluzione per infusione
DE/H/1222/001 039990015 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CARBOPLATINO AUROBINDO 10 mg/ml concentrato per soluzione per infusione
DE/H/1222/001 039990027 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CARBOPLATINO AUROBINDO 10 mg/ml concentrato per soluzione per infusione
DE/H/1222/001 039990039 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
List of nationally authorised medicinal products EMA/753864/2016 Page 34/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CARBOPLATINO AUROBINDO 10 mg/ml concentrato per soluzione per infusione
DE/H/1222/001 039990041 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
CARBOPLATINO AUROBINDO 10 mg/ml concentrato per soluzione per infusione
DE/H/1222/001 039990054 AUROBINDO PHARMA (ITALIA) S.R.L.
IT
Carboplatino Aurovitas Spain 10 mg/ml concentrado para solución para perfusión EFG
not available 69.463 AUROVITAS SPAIN,S.A.U. ES
Carboplatino Cipla 10 mg/ml concentrato per soluzione per infusione
SE/H/1425/001/DC 043451018 043451020 043451032 043451044
CIPLA EUROPE NV IT
Carboplatino Hospira 150 mg/15 ml soluzione iniettabile per uso endovenoso
not available 028491025 HOSPIRA ITALIA S.R.L IT
Carboplatino Hospira 450 mg/45 ml soluzione iniettabile per uso endovenoso
not available 028491037 HOSPIRA ITALIA S.R.L IT
Carboplatino Hospira 50 mg/ 5 ml soluzione iniettabile per uso endovenoso
not available 028491013 HOSPIRA ITALIA S.R.L IT
Carboplatino Hospira 600 mg/60 ml soluzione iniettabile per uso endovenoso
not available 028491076 HOSPIRA ITALIA S.R.L IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696015/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696027/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696039/M FRESENIUS KABI ONCOLOGY PLC.
IT
List of nationally authorised medicinal products EMA/753864/2016 Page 35/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696041/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696015/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696027/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696039/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrato per soluzione per infusione
UK/H/4181/001 040696041/M FRESENIUS KABI ONCOLOGY PLC.
IT
Carboplatino Kabi 10 mg/ml concentrado para solución para perfusión EFG
UK/H/4181/001 76092 FRESENIUS KABI ONCOLOGY PLC.
ES
Carboplatino Kabi 10 mg/ml concentrado para solución para perfusión EFG
UK/H/4181/001 76092 FRESENIUS KABI ONCOLOGY PLC.
ES
CARBOPLATINO Pfizer 150 mg/15 ml soluzione per infusione
not available 032776027 PFIZER ITALIA S.R.L. IT
CARBOPLATINO Pfizer 450 mg/45 ml soluzione per infusione
not available 032776039 PFIZER ITALIA S.R.L. IT
CARBOPLATINO Pfizer 50 mg/5 ml soluzione per infusione
not available 032776015 PFIZER ITALIA S.R.L. IT
Carboplatino Sandoz NL/H/3556/001 037050010 SANDOZ S.P.A. IT Carboplatino Sandoz NL/H/3556/001 037050022 SANDOZ S.P.A. IT Carboplatino Sandoz NL/H/3556/001 037050059 SANDOZ S.P.A. IT Carboplatino Sandoz NL/H/3556/001 037050061 SANDOZ S.P.A. IT Carboplatino Sandoz NL/H/3556/001 037050073 SANDOZ S.P.A. IT Carboplatino Sandoz NL/H/3556/001 037050046 SANDOZ S.P.A. IT
List of nationally authorised medicinal products EMA/753864/2016 Page 36/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatino Sandoz NL/H/3556/001 037050034 SANDOZ S.P.A. IT Carboplatino Sandoz 150mg/15ml solución para perfusión EFG
NOT APPLICABLE 63.169 SANDOZ FARMACÉUTICA, S.A.
ES
Carboplatino Sandoz 450mg/45ml solución para perfusión EFG
NOT APPLICABLE 63.168 SANDOZ FARMACÉUTICA, S.A.
ES
Carboplatino Sandoz 50mg/5ml solución para perfusión EFG
NOT APPLICABLE 63.170 SANDOZ FARMACÉUTICA, S.A.
ES
Carboplatino SUN 10 mg/ml concentrado para solución para perfusión EFG
UK/H/1370/001 72138 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
ES
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946025 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946076 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946102 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946052 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946013 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946037 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946090 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
List of nationally authorised medicinal products EMA/753864/2016 Page 37/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946088 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946049 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946126 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946114 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
Carboplatino SUN 10 mg/ml concentrato per soluzione per infusione
UK/H/1370/001 039946064 SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347068 TEVA PHARMA B.V. IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347031 TEVA PHARMA B.V. IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347017 TEVA PHARMA B.V. IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347029 TEVA PHARMA B.V. IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347043 TEVA PHARMA B.V. IT
CARBOPLATINO TEVA 10 mg/ml
UK/H/0273/001 034347056 TEVA PHARMA B.V. IT
Carboplatino Teva 10 mg/ml Concentrado para solución para perfusión
UK/H/0273/001 65108 TEVA PHARMA S.L.U ES
Carboplatin-TEVA 10 mg/ml not available 9700222 TEVA PHARMACEUTICALS BULGARIA EOOD
BG
Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion
not available PA 0749/004/001 TEVA PHARMA B.V. IE
List of nationally authorised medicinal products EMA/753864/2016 Page 38/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carboplatin-Teva 150 mg pulveris injekciju šķīduma pagatavošanai
not available 99-0763 TEVA PHARMA B.V. LV
Carboplatinum Pfizer 150 mg Concentraat voor oplossing voor infusie
not available BE174754 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 150 mg Konzentrat zur Herstellung einer Infusionslösung
not available BE174754 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 150 mg Solution à diluer pour perfusion
not available BE174754 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 150 mg Solution à diluer pour perfusion
not available 2010010695 PFIZER S.A. (BELGIUM) LU
Carboplatinum Pfizer 450 mg Concentraat voor oplossing voor infusie
not available BE174763 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 450 mg Konzentrat zur Herstellung einer Infusionslösung
not available BE174763 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 450 mg Solution à diluer pour perfusion
not available BE174763 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 450 mg Solution à diluer pour perfusion
not available 2010010696 PFIZER S.A. (BELGIUM) LU
Carboplatinum Pfizer 50 mg Concentraat voor oplossing voor infusie
not available BE174553 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 50 mg Konzentrat zur Herstellung einer Infusionslösung
not available BE174553 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 50 mg Solution à diluer pour perfusion
not available BE174553 PFIZER S.A. (BELGIUM) BE
Carboplatinum Pfizer 50 mg Solution à diluer pour perfusion
not available 2010010694 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/753864/2016 Page 39/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Carbosin 10 mg/ml, concentraat voor oplossing voor intraveneuze infusie
not available RVG 23244 PHARMACHEMIE B.V NL
CARBOSIN 150 mg Konzentrat zur Herstellung einer Infusionslösung 10 mg/ml
not available BE170283 TEVA PHARMA BELGIUM N.V./S.A
BE
CARBOSIN 150 mg solution à diluer pour perfusion 10 mg/ml
not available 2006060033 TEVA PHARMA BELGIUM N.V./S.A
LU
CARBOSIN 450 mg concentraat voor oplossing voor infusie 10 mg/ml
not available BE170292 TEVA PHARMA BELGIUM N.V./S.A
BE
CARBOSIN 450 mg solution à diluer pour perfusion 10 mg/ml
not available 2006060034 TEVA PHARMA BELGIUM N.V./S.A
LU
CARBOSIN 50 mg Konzentrat zur Herstellung einer Infusionslösung 10 mg/ml
not available BE170222 TEVA PHARMA BELGIUM N.V./S.A
BE
CARBOSIN 50 mg solution à diluer pour perfusion 10 mg/ml
not available 2006060032 TEVA PHARMA BELGIUM N.V./S.A
LU
CARBOSIN 600 mg concentraat voor oplossing voor infusie 10 mg/ml
not available BE276936 TEVA PHARMA BELGIUM N.V./S.A
BE
CARBOSIN 600 mg solution à diluer pour perfusion 10 mg/ml
not available 2006060035 TEVA PHARMA BELGIUM N.V./S.A
LU
CarbosinTM 10 mg/ml infuusiokonsentraatti, liuosta varten Ô
not available 11047 PHARMACHEMIE BV FI
Cycloplatin 10 mg/ml koncentrátum oldatos infúzióhoz
not available OGYI-T-4336/03 TEVA GYÓGYSZERGYÁR ZRT HU
Cycloplatin 10 mg/ml koncentrátum oldatos infúzióhoz
not available OGYI-T-4336/02 TEVA GYÓGYSZERGYÁR ZRT HU
Cycloplatin 10 mg/ml koncentrátum oldatos infúzióhoz
not available OGYI-T-4336/01 TEVA GYÓGYSZERGYÁR ZRT HU
List of nationally authorised medicinal products EMA/753864/2016 Page 40/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
CYCLOPLATIN 150 Koncentrát pro infuzní roztok
not available 44/108/88-B/C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
CYCLOPLATIN 450 Koncentrát pro infuzní roztok
not available 44/108/88-C/C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
CYCLOPLATIN 50 Koncentrát pro infuzní roztok
not available 44/108/88-A/C TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Eurocarboplatin® 10 mg/ml not available 51006.00.00 LAPHARM PHARMACEUTICAL PRODUCTS LTD
DE
Karboplatin Hospira 10 mg/ml koncentrat za raztopino za infundiranje
not available 5363-I-843/11 HOSPIRA UK LTD SI
Karboplatin Hospira 10 mg/ml koncentrat za raztopino za infundiranje
not available 563-I-844/11 HOSPIRA UK LTD SI
Karboplatin Hospira 10 mg/ml koncentrat za raztopino za infundiranje
not available 563-I-845/11 HOSPIRA UK LTD SI
Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/0803/001 5363-I-488/10 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SI
Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/0803/001 5363-I-489/10 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SI
Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/0803/001 5363-I-490/10 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SI
Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/0803/001 5363-I-491/10 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SI
List of nationally authorised medicinal products EMA/753864/2016 Page 41/41
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Karboplatin medac 10 mg/ml koncentrat za raztopino za infundiranje
DE/H/0803/001 5363-I-492/10 MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
SI
MEGAPLATIN not available 41613/11-11-2009 GENEPHARM S.A. GR Neocarbo 10 mg/ml 2143536 43536.00.00 HEXAL AG DE Novoplatinum , 10 mg/ml, Solução para perfusão
not available 8722413 HOSPIRA PORTUGAL LDA PT
Novoplatinum, 10 mg/ml, Solução para perfusão
not available 8722421 HOSPIRA PORTUGAL LDA PT
PARAPLATIN 150 mg/15 ml soluzione iniettabile per uso endovenoso
not available 026706046 BRISTOL-MYERS SQUIBB S.R.L.
IT
PARAPLATIN 150 mg/15 ml solution for infusion
58.542 Bristol-Myers Squibb SA
ES
PARAPLATIN 450 mg/45 ml soluzione iniettabile per uso endovenoso
not available 026706059 BRISTOL-MYERS SQUIBB S.R.L.
IT
PARAPLATIN 450 mg/45 ml solution for infusion
58.52 Bristol-Myers Squibb SA
ES
PARAPLATIN SOL. INF.150MG/15ML/Vial
not available 1947605 Bristol-Myers Squibb SA
EL
Ribocarbo®-L 10 mg/ml – Konzentrat zur Herstellung einer Infusionslösung
not available 3002152.00.00 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
DE
Zytax® 150 mg/15 ml not available 49695.00.00 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
DE
Zytax® 450 mg/45 ml not available 49696.00.00 HIKMA FARMACÊUTICA (PORTUGAL), S.A.
DE
Карбоплатин „Ебеве” 10 mg/ml концентрат за инфузионен разтвор
not available 9900409 EBEWE PHARMA BG
