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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
30 November 2017 EMA/811808/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: estradiol / norethisterone
Procedure no.: PSUSA/00001278/201703
List of nationally authorised medicinal products EMA/811808/2017 Page 2/24
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
Activelle 1 mg + 0,5 mg, tabletki powlekane
not available 4512 NOVO NORDISK A/S PL
Activelle 1 mg/0.5 mg film-coated tablets
not available MA 104/00501 NOVO NORDISK A/S MT
Activelle 1 mg/0,5 mg, Filmtabletten
SE/H/0150/001 BE196515 NOVO NORDISK PHARMA SA BE
Activelle 1 mg/0,5 mg, Filmtabletten
SE/H/0150/001 2009020162 NOVO NORDISK PHARMA SA LU
Activelle filmtabletta SE/H/0150/001 OGYI-T-7031/02 NOVO NORDISK A/S HU
Активел 1 mg/0,5 mg филмирани таблетки
SE/H/0150/001 II-26801 NOVO NORDISK A/S BG
Activelle 1 mg/0,5 mg, comprimés pelliculés
SE/H/0150/001 2009020162 NOVO NORDISK PHARMA SA LU
Activelle 1 mg/0,5 mg filmom obložene tablete
HR-H-673855616 UP/I-530-09/14-01/257 NOVO NORDISK A/S HR
Activelle 1 mg/0,5 mg filmdragerade tabletter
SE/H/0150/001 13621 NOVO NORDISK A/S FI
Kliovance 1 mg/0.5 mg film-coated tablets
SE/H/0150/001 PL 03132/0125 NOVO NORDISK LIMITED UK
Activelle 1 mg/0,5 mg comprimidos recubiertos con película
SE/H/0150/001 62.465 ISDIN, S.A. ES
List of nationally authorised medicinal products EMA/811808/2017 Page 3/24
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
Activelle 1 mg/0.5 mg film-coated tablets
SE/H/0150/001 PA 218/52/1 NOVO NORDISK A/S IE
Activelle 1 mg/0,5 mg Filmtabletten
SE/H/0150/001 1-22699 NOVO NORDISK PHARMA GMBH
AT
Activelle 1 mg/0,5 mg filmomhulde tabletten
SE/H/0150/001 BE196515 NOVO NORDISK PHARMA SA BE
Activelle 1 mg/0,5 mg, comprimés pelliculés
SE/H/0150/001 BE196515 NOVO NORDISK PHARMA SA BE
Activelle 1 mg/0,5 mg potahované tablety
SE/H/0150/001 56/827/99-C NOVO NORDISK A/S CZ
Activelle 1 mg/0,5 mg Filmtabletten Estradiol / Norethisteronacetat
SE/H/0150/001 43555.00.00 NOVO NORDISK PHARMA GMBH
DE
Activelle 1 mg/0,5 mg plėvele dengtos tabletės
SE/H/0150/001 LT/1/05/0298/002 NOVO NORDISK A/S LT
Activelle 1 mg/0,5mg compresse rivestite con film
SE/H/0150/001 034117022/M NOVO NORDISK SPA IT
Activelle, 1 mg/0,5 mg õhukese polümeerikattega tabletid
SE/H/0150/001 291799 NOVO NORDISK A/S EE
List of nationally authorised medicinal products EMA/811808/2017 Page 4/24
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
Activelle 1 mg/0,5 mg kalvopäällysteiset tabletit
SE/H/0150/001 13621 NOVO NORDISK A/S FI
ACTIVELLE, comprimé pelliculé
SE/H/0150/001 NL 23753 NOVO NORDISK FR
Activelle filmtabletta SE/H/0150/001 OGYI-T-7031/01 NOVO NORDISK A/S HU
Activelle 1 mg/0,5 mg plėvele dengtos tabletės
SE/H/0150/001 LT/1/05/0298/001 NOVO NORDISK A/S LT
Activelle 1 mg/0,5 mg apvalkotās tabletes
SE/H/0150/001 05-0410 NOVO NORDISK A/S LV
Activelle®, filmomhulde tabletten
SE/H/0150/001 RVG 22819 NOVO NORDISK B.V. NL
Activelle 1 mg/0,5 mg filmom obalenè tablety
SE/H/0150/001 56/0215/05-S NOVO NORDISK A/S SK
Activelle SE/H/0150/001 30095 NOVO NORDISK A/S DK
Activelle 1 mg/0,5 mg filmdragerade tabletter
SE/H/0150/001 14007 NOVO NORDISK A/S SE
Activelle 1 mg/0,5 mg filmsko obložene tablete
SE/H/0150/001 H/99/00114/001 NOVO NORDISK A/S SI
Activelle 1 mg/0,5 mg filmsko obložene tablete
SE/H/0150/001 H/99/00114/002 NOVO NORDISK A/S SI
List of nationally authorised medicinal products EMA/811808/2017 Page 5/24
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
Activelle 1 mg/0,5 mg tablett, filmdrasjert
SE/H/0150/001 05/3235 NOVO NORDISK A/S NO
Activelle SE/H/0150/001 980218 NOVO NORDISK A/S IS
Activelle 1 mg/0,5mg compresse rivestite con film
SE/H/0150/001 034117010/M NOVO NORDISK SPA IT
Activelle 1mg/0,5mg comprimido revestido
SE/H/0150/001 2819282 ISDIN LDA PT
Activelle 1mg/0,5mg comprimido revestido
SE/H/0150/001 2819381 ISDIN LDA PT
Estramon conti® 40/130 Mikrogramm/24 h Transdermales Pflaster
DE/H/3299/002 70879.00.00 HEXAL AG DE
Estramon conti® 30/95 Mikrogramm/24 h Transdermales Pflaster
DE/H/3299/001 70878.00.00 HEXAL AG DE
Kliogest 2 mg/1 mg, Filmtabletten
not available BE165462 NOVO NORDISK PHARMA SA BE
Kliogest 2 mg/1 mg, Filmtabletten
not available 0642/03/12/7922 NOVO NORDISK PHARMA SA LU
Kliogest 2 mg/1 mg filmdragerade tabletter
not available 10575 NOVO NORDISK A/S FI
List of nationally authorised medicinal products EMA/811808/2017 Page 6/24
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
Kliovance 1 mg/0.5 mg film-coated tablets
SE/H/0150/001 PL 03132/0125 NOVO NORDISK LIMITED UK
Kliogest 2 mg/1 mg film-coated tablets
not available PA 218/22/1 NOVO NORDISK A/S IE
Kliogest 2mg/1mg Filmtabletten
not available 1-19017 NOVO NORDISK PHARMA GMBH
AT
Kliogest 2 mg/1 mg, filmomhulde tabletten
not available BE165462 NOVO NORDISK PHARMA SA BE
Kliogest 2 mg/1 mg comprimés pelliculés
not available BE165462 NOVO NORDISK PHARMA SA BE
Kliogest 2mg/1mg potahované tablety
DK/H/0102/001 56/302/91-C NOVO NORDISK A/S CZ
Kliogest N 2 mg/1 mg Filmtabletten
not available 26118.00.00 NOVO NORDISK PHARMA GMBH
DE
Kliogest 2 mg/1 mg plėvele dengtos tabletės
DK/H/0102/001 LT/1/05/0306/002 NOVO NORDISK A/S LT
Kliogest filmtabletta DK/H/0102/001 OGYI-T-1877/02 NOVO NORDISK A/S HU
Kliogest, 2 mg/1 mg õhukese polümeerikattega tabletid
DK/H/0102/001 204998 NOVO NORDISK A/S EE
List of nationally authorised medicinal products EMA/811808/2017 Page 7/24
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
Kliogest kalvopäällysteiset tabletit
not available 10575 NOVO NORDISK A/S FI
KLIOGEST, comprimé pelliculé
not available NL 15139 NOVO NORDISK FR
Kliogest filmtabletta DK/H/0102/001 OGYI-T-1877/01 NOVO NORDISK A/S HU
Kliogest 2 mg/1 mg plėvele dengtos tabletės
DK/H/0102/001 LT/1/05/0306/001 NOVO NORDISK A/S LT
Kliogest 2 mg/1 mg apvalkotās tabletes
DK/H/0102/001 05-0411 NOVO NORDISK A/S LV
Kliogest, filmomhulde tabletten
not available RVG 14942 NOVO NORDISK B.V. NL
Kliogest, 2 mg + 1 mg, tabletki powlekane
not available R/3297 NOVO NORDISK A/S PL
Kliogest DK/H/0102/001 11768 NOVO NORDISK A/S DK
Kliogest 2 mg/1 mg, comprimés pelliculés
not available 0642/03/12/7922 NOVO NORDISK PHARMA SA LU
Kliogest 2 mg/1 mg filmsko obložene tablete
DK/H/0102/001 H/92/00845/001 NOVO NORDISK A/S SI
Kliogest 2 mg/1 mg filmsko obložene tablete
DK/H/0102/001 H/92/00845/002 NOVO NORDISK A/S SI
List of nationally authorised medicinal products EMA/811808/2017 Page 8/24
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
Kliogest filmuhúðaðar töflur
DK/H/0102/001 843355 NOVO NORDISK A/S IS
Kliogest®, 2 mg + 1 mg, Comprimido revestido por película
not available 2280782 ISDIN LDA PT
Trisequens, Filmtabletten not available BE156134 NOVO NORDISK PHARMA SA BE
Trisequens, Filmtabletten not available 0642/08039743 NOVO NORDISK PHARMA SA LU
Trisequens filmsko obložene tablete
not available H/97/01568/001 NOVO NORDISK A/S SI
Trisequens, δισκία επικαλυμμένα με λεπτό υμένιο
not available 13501 NOVO NORDISK HELLAS LTD.
CY
Trisekvens filmdragerade tabletter
not available 8424 NOVO NORDISK A/S FI
Trisequens® comprimidos recubiertos
not available 60.706 ISDIN, S.A. ES
Trisequens film-coated tablets
not available PL 03132/0122 NOVO NORDISK LIMITED UK
Trisequens film-coated tablets
not available PA 218/8/1 NOVO NORDISK A/S IE
Trisequens potahované tablety
not available 56/307/91-C NOVO NORDISK A/S CZ
List of nationally authorised medicinal products EMA/811808/2017 Page 9/24
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
Трисеквенс филмирана таблетки
not available 20010005 NOVO NORDISK A/S BG
Trisequens, comprimés pelliculés
not available BE156134 NOVO NORDISK PHARMA SA BE
Trisequens, filmomhulde tabletten
not available BE156134 NOVO NORDISK PHARMA SA BE
Trisequens - Filmtabletten
not available 16.893 NOVO NORDISK PHARMA GMBH
AT
Trisequens Filmtabletten Estradiol / Norethisteronacetat
not available 6529829.00.00 NOVO NORDISK PHARMA GMBH
DE
Trisequens, õhukese polümeerikattega tabletid
not available 205098 NOVO NORDISK A/S EE
Trisekvens kalvopäällysteiset tabletit
not available 8424 NOVO NORDISK A/S FI
TRISEQUENS, comprimé pelliculé
not available NL 12375 NOVO NORDISK FR
Trisequens filmom obložene tablete
not available HR-H-919057630 NOVO NORDISK HRVATSKA D.O.O.
HR
Trisequens filmtabletta not available OGYI-T-5851/01 NOVO NORDISK A/S HU
List of nationally authorised medicinal products EMA/811808/2017 Page 10/24
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
Trisequens, δισκία επικαλυμμένα με λεπτό υμένιο
not available 46163/06-07-2015 NOVO NORDISK HELLAS LTD.
GR
Trisequens plėvele dengtos tabletės
not available LT/1/94/0158/001 NOVO NORDISK A/S LT
Trisequens apvalkotās tabletes
not available 98-0705 NOVO NORDISK A/S LV
Trisequens, filmomhulde tablet
not available RVG 09812 NOVO NORDISK B.V. NL
Trisequens, 2 mg (niebieskie), 2 mg + 1 mg (białe), 1 mg (czerwone), tabletki powlekane
not available R/3299 NOVO NORDISK A/S PL
Trisekvens, filmovertrukne tabletter
not available 6699 NOVO NORDISK A/S DK
Trisequens, comprimés pelliculés
not available 0642/08039743 NOVO NORDISK PHARMA SA LU
Trisekvens tablett, filmdrasjert
not available 6323 NOVO NORDISK A/S NO
Trisekvens filmuhúðaðar töflur
not available 751874 NOVO NORDISK A/S IS
List of nationally authorised medicinal products EMA/811808/2017 Page 11/24
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
Trisequens associação comprimidos revestidos por película
not available 2480986 ISDIN LDA PT
Novofem Filmtabletten DE/H/0304/001 BE231682 NOVO NORDISK PHARMA SA BE
Novofem, Filmtabletten DE/H/0304/001 0642/07039243 NOVO NORDISK PHARMA SA LU
Novofem filmsko obložene tablete
DE/H/0304/001 H/03/01133/001 NOVO NORDISK A/S SI
Novofem filmom obložene tablete
DE/H/0304/001 HR-H-818589847 NOVO NORDISK A/S HR
Novofem filmdragerade tabletter
DE/H/0304/001 16601 NOVO NORDISK A/S FI
Duofemme comprimidos recubiertos con película
DE/H/1/0304/01 64.718 ISDIN, S.A. ES
Novofem film-coated tablet
DE/H/0304/001 PL 03132/0141 NOVO NORDISK LIMITED UK
Novofem film-coated tablets
DE/H/0304/001 PA 218/053/001 NOVO NORDISK A/S IE
Novofem potahované tablety
DE/H/0304/001 56/005/03-C NOVO NORDISK A/S CZ
Novofem, comprimés pelliculés
DE/H/0304/001 BE231682 NOVO NORDISK PHARMA SA BE
List of nationally authorised medicinal products EMA/811808/2017 Page 12/24
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
Novofem, filmomhulde tabletten
DE/H/0304/001 BE231682 NOVO NORDISK PHARMA SA BE
Novofem Filmtabletten Estradiol / Norethisteronacetat
DE/H/0304/001 47567.00.00 NOVO NORDISK PHARMA GMBH
DE
Novofem, õhukese polümeerikattega tabletid
DE/H/0304/001 407903 NOVO NORDISK A/S EE
Novofem kalvopäällysteiset tabletit
DE/H/0304/001 16601 NOVO NORDISK A/S FI
NOVOFEMME, comprimé pelliculé
DE/H/0304/001 NL 26893 NOVO NORDISK FR
Novofem filmtabletta DE/H/0304/001 OGYI-T-10 607/01 NOVO NORDISK A/S HU
Novofem plėvele dengtos tabletės
DE/H/0304/001 LT/1/05/0316/002 NOVO NORDISK A/S LT
Novofem plėvele dengtos tabletės
DE/H/0304/001 LT/1/05/0316/001 NOVO NORDISK A/S LT
Novofem apvalkotās tabletes
DE/H/0304/001 05-0412 NOVO NORDISK A/S LV
Novofem, filmomhulde tabletten
DE/H/0304/001 RVG 26864 NOVO NORDISK B.V. NL
List of nationally authorised medicinal products EMA/811808/2017 Page 13/24
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
Novofem, tabletki powlekane
DE/H/0304/001 11888 NOVO NORDISK A/S PL
Novofem filmom obalené tablety
DE/H/0304/001 56/0291/05-S NOVO NORDISK A/S SK
Novofem filmovertrukne tabletter
DE/H/0304/001 32745 NOVO NORDISK A/S DK
Novofem filmdragerade tabletter
DE/H/0304/001 17439 NOVO NORDISK A/S SE
Novofem, comprimés pelliculés
DE/H/0304/001 0642/07039243 NOVO NORDISK PHARMA SA LU
Novofem filmsko obložene tablete
DE/H/0304/001 H/03/01133/002 NOVO NORDISK A/S SI
Novofem tablett, filmdrasjert
DE/H/0304/001 01-5767 NOVO NORDISK A/S NO
Novofem filmuhúðaðar töflur
DE/H/0304/001 IS/1/01/040/01 NOVO NORDISK A/S IS
Novofem comprimidos revestidos por película
DE/H/0304/001 3804986 ISDIN LDA PT
Novofem comprimidos revestidos por película
DE/H/0304/001 3805082 ISDIN LDA PT
Activelle minor 0,5 mg/0,1 mg Filmtabletten
SE/H/0150/002 BE329682 NOVO NORDISK PHARMA SA BE
List of nationally authorised medicinal products EMA/811808/2017 Page 14/24
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
Activelle minor 0,5 mg/0,1 mg Filmtabletten
SE/H/0150/002 2009120001 NOVO NORDISK PHARMA SA LU
Eviana 0,5 mg/0,1 mg Filmtabletta
SE/H/0150/002 OGYI-T-22398/02 NOVO NORDISK A/S HU
Noviana 0,5 mg/0,1 mg filmdragerade tabletter
SE/H/0150/002 24071 NOVO NORDISK A/S FI
Eviana 0,5 mg/0,1 mg comprimidos recubiertos
SE/H/0150/002 70.576 ISDIN, S.A. ES
Activelle 0,5 mg/0,1 mg Filmtabletten
SE/H/0150/002 1-27819 NOVO NORDISK PHARMA GMBH
AT
Activelle minor 0,5 mg/0,1 mg filmomhulde tabletten
SE/H/0150/002 BE329682 NOVO NORDISK PHARMA SA BE
Activelle minor 0,5 mg/0,1 mg, comprimés pelliculés
SE/H/0150/002 BE329682 NOVO NORDISK PHARMA SA BE
Activelle 0,5 mg/0,1 mg compresse rivestite con film
SE/H/0150/002 034117046/M NOVO NORDISK A/S IT
Eviana, 0,5 mg/0,1 mg õhukese polümeerikattega tabletid
SE/H/0150/002 606708 NOVO NORDISK A/S EE
List of nationally authorised medicinal products EMA/811808/2017 Page 15/24
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
Noviana 0,5 mg/0,1 mg kalvopäällysteiset tabletit
SE/H/0150/002 24071 NOVO NORDISK A/S FI
Activelle 0,5 mg/0,1 mg compresse rivestite con film
SE/H/0150/002 034117034/M NOVO NORDISK A/S IT
Eviana filmomhulde tabletten
SE/H/0150/002 RVG 100983 NOVO NORDISK B.V. NL
Activelle low SE/H/0150/002 42023 NOVO NORDISK A/S DK
Eviana 0,5 mg/0,1 mg filmdragerade tabletter
SE/H/0150/002 23381 NOVO NORDISK A/S SE
Activelle minor 0,5 mg/0,1 mg, comprimés pelliculés
SE/H/0150/002 2009120001 NOVO NORDISK PHARMA SA LU
Eviana 0,5 mg/0,1 mg tablett, filmdrasjert
SE/H/0150/002 07-5213 NOVO NORDISK A/S NO
Activelle low SE/H/0150/002 IS/1/08/002/01 NOVO NORDISK A/S IS
Activelle 0,5 mg/0,1 mg Comprimido revestido por película
SE/H/0150/002 5192703 ISDIN LDA PT
Activelle 0,5 mg/0,1 mg Comprimido revestido por película
SE/H/0150/002 5192679 ISDIN LDA PT
List of nationally authorised medicinal products EMA/811808/2017 Page 16/24
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
Eviana 0,5 mg/0,1 mg filmtabletta
SE/H/0150/002 OGYI-T-22398/01 NOVO NORDISK A/S HU
ESTALIS 50 Mikrogramm /250 Mikrogramm/24 Stunden transdermales Pflaster
SE/H/0148/001 BE199245 NOVARTIS PHARMA N.V. BE
Sequidot transdermalni flaster
SE/H/0149/002 HR-H-674150675-01 NOVARTIS HRVATSKA D.O.O.
HR
Sequidot transdermalni flaster
SE/H/0149/002 HR-H-674150675-02 NOVARTIS HRVATSKA D.O.O.
HR
ESTALIS 0,6 mg; 50 µg/24h + 2,7 mg; 140 µg/24h, system transdermalny
not available 8166 NOVARTIS POLAND SP. Z O. O.
PL
Estalis; 0,5mg; 50 µg/24h + 4,8 mg; 250 µg/24h, system transdermalny
not available 8165 NOVARTIS POLAND SP. Z O. O.
PL
MERIGEST® 2 MG/0,7 MG FILMTABLETTEN
UK/H/0143/001 39491.00.00 NOVARTIS PHARMA GMBH DE
Climesse® 2mg/0.7 film-coated tablets
UK/H/0143/001 PL 00101/0396 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
List of nationally authorised medicinal products EMA/811808/2017 Page 17/24
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
Estalis 50 microgramas/250 microgramas/24 horas, adesivo transdérmico
SE/H/0148/001 2777084 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Estalis 50 microgramas/250 microgramas/24 horas, adesivo transdérmico
SE/H/0148/001 2777183 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
Estalis 50 microgramas/250 microgramas/24 horas, adesivo transdérmico
SE/H/0148/001 4800587 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
ESTALIS SEQUI cerotti transdermici
SE/H/0149/002 034209039 NOVARTIS FARMA S.P.A. IT
ESTALIS SEQUI cerotti transdermici
SE/H/0149/002 034209041 NOVARTIS FARMA S.P.A. IT
ESTALIS SEQUI, adesivo transdérmico
SE/H/0149/002 5019526 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
ESTALIS SEQUI, adesivo transdérmico
SE/H/0149/002 5019534 NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A.
PT
List of nationally authorised medicinal products EMA/811808/2017 Page 18/24
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
Estalis 50 μικρογραμμάρια/250 μικρογραμμάρια/24 ώρες, διαδερμικό έμπλαστρο
SE/H/0148/001 250630101 NOVARTIS (HELLAS) S.A.C.I.
GR
Estalis 50 μικρογραμμάρια/250 μικρογραμμάρια/24 ώρες, διαδερμικό έμπλαστρο
SE/H/0148/001 250630102 NOVARTIS (HELLAS) S.A.C.I.
GR
Estalis 50 mikrog/250 mikrog per 24 tuntia depotlaastari
SE/H/0148/001 13620 NOVARTIS FINLAND OY FI
Estalis 50 mikrog/250 mikrog/24 timmar, depotplåster
SE/H/0148/001 13620 NOVARTIS FINLAND OY FI
ESTALIS 50 microgramos/250 microgramos/24 horas, parche transdérmico
SE/H/0148/001 62.463 NOVARTIS FARMACÉUTICA S.A.
ES
ESTALIS SEQUIDOT parche transdérmico
SE/H/0149/002 69.746 NOVARTIS FARMACÉUTICA S.A.
ES
Sequidot depotlaastari SE/H/0149/002 22301 NOVARTIS FINLAND OY FI
List of nationally authorised medicinal products EMA/811808/2017 Page 19/24
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
Sequidot transdermal patches
SE/H/0149/002 22301 NOVARTIS FINLAND OY FI
Sequidot® 50/250 Mikrogramm/24 Stunden transdermales Pflaster
SE/H/0149/002 66641.00.00 NOVARTIS PHARMA GMBH DE
CLIMAGEST 2mg film-coated tablet
UK/H/0127/001 PL 00101/0366 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
Estalis 50/250 - transdermale Pflaster
SE/H/0148/001 1-22840 NOVARTIS PHARMA GMBH AT
Estalis 50/250 mikrogram/ 24 timmar, depotplåster
SE/H/0148/001 13868 NOVARTIS SVERIGE AB SE
Sequidot 2-Phasen transdermale Matrixpflaster
SE/H/0149/002 1-26854 NOVARTIS PHARMA GMBH AT
Sequidot transdermal patches
SE/H/0149/002 21846 NOVARTIS SVERIGE AB SE
Estalis 50 mikrog /250 mikrog per 24 timer “Novartis”
not available 98-3106 NOVARTIS NORGE AS NO
Sequidot depotplaster not available 04-3137 NOVARTIS NORGE AS NO
List of nationally authorised medicinal products EMA/811808/2017 Page 20/24
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
Estalis 50 microgram/250 microgram/24 uur, pleister voor transdermaal gebruik
SE/H/0148/001 BE199245 NOVARTIS PHARMA N.V. BE
ESTALIS 50/250 dispositifs transdermiques
SE/H/0148/001 BE199245 NOVARTIS PHARMA N.V. BE
ESTALIS SEQUIDOT, διαδερμικό έμπλαστρο
SE/H/0149/002 273100101 NOVARTIS (HELLAS) S.A.C.I.
GR
ESTALIS SEQUIDOT, διαδερμικό έμπλαστρο
SE/H/0149/002 273100102 NOVARTIS (HELLAS) S.A.C.I.
GR
Mericomb 1 mg Filmtabletten
UK/H/0127/002 39490.00.00 NOVARTIS PHARMA GMBH DE
Mericomb 2 mg Filmtabletten
UK/H/0127/001 37970.00.00 NOVARTIS PHARMA GMBH DE
Climagest 1mg film-coated tablet
UK/H/0127/002 PL 00101/0328 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
CLIMAGEST 2mg film-coated tablet
UK/H/0127/001 PL 00101/0366 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
List of nationally authorised medicinal products EMA/811808/2017 Page 21/24
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
Mericomb 1 mg Filmtabletten
UK/H/0127/002 39490.00.00 NOVARTIS PHARMA GMBH DE
Mericomb 2 mg Filmtabletten
UK/H/0127/001 37970.00.00 NOVARTIS PHARMA GMBH DE
Climagest 1mg film-coated tablet
UK/H/0127/002 PL 00101/0328 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
Kliane 1 mg/2 mg plėvele dengtos tabletės
not available LT/1/2000/0892/001 BAYER PHARMA AG LT
Kliane 1 mg/2 mg apvalkotās tabletes
not available 00-1227 BAYER PHARMA AG LV
KLIANE Potahované tablety
not available 56/177/00-C BAYER AG CZ
Nuvelle™ Continuous not available PL 00010/0552 BAYER PLC UK
Evo-Sequi not available 18601 JANSSEN-CILAG A/S DK
Evo-Conti not available 18600 JANSSEN-CILAG A/S DK
EVOREL CONTI not available PL 00242/0319 JANSSEN-CILAG LIMITED UK
EVOREL SEQUI not available PL 00242/0320 JANSSEN-CILAG LIMITED UK
Evorel Conti forðaplástur.
not available 960226 JANSSEN-CILAG AB IS
List of nationally authorised medicinal products EMA/811808/2017 Page 22/24
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
SYSTEN SEQUI: Systen 50; 3,2 mg + Systen Conti; 3,2 mg +11,2 mg, system transdermalny
not available 4448 JANSSEN-CILAG INTERNATIONAL NV
PL
Evorel Sequi forðaplástur.
not available 960227 JANSSEN-CILAG AB IS
SYSTEN CONTI; 3,2 mg + 11,2 mg, system transdennalny
not available 4447 JANSSEN-CILAG INTERNATIONAL NV
PL
Evorel Conti 50/170 micrograms per 24 hours Transdermal patch
not available PA 748/008/001 JANSSEN-CILAG LIMITED IE
EVOREL SEQUI depotlaastari
not available 12676 JANSSEN-CILAG OY FI
EVOREL CONTI depotlaastari
not available 12674 JANSSEN-CILAG OY FI
MERIGEST® 2 MG/0,7 MG FILMTABLETTEN
UK/H/0143/001 39491.00.00 NOVARTIS PHARMA GMBH DE
Climesse® 2mg/0.7 film-coated tablets
UK/H/0143/001 PL 00101/0396 NOVARTIS PHARMACEUTICALS UK LIMITED
UK
Kliogest 2 mg/1 mg, Filmtabletten
not available BE165462 NOVO NORDISK PHARMA SA BE
List of nationally authorised medicinal products EMA/811808/2017 Page 23/24
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
Kliogest 2 mg/1 mg, Filmtabletten
not available 0642/03/12/7922 NOVO NORDISK PHARMA SA LU
Kliogest 2 mg/1 mg filmdragerade tabletter
not available 10575 NOVO NORDISK A/S FI
Kliofem® film-coated tablets
not available PL 3132/0080 NOVO NORDISK LIMITED UK
Kliogest 2 mg/1 mg film-coated tablets
not available PA 218/22/1 NOVO NORDISK A/S IE
Kliogest 2mg/1mg Filmtabletten
not available 1-19017 NOVO NORDISK PHARMA GMBH
AT
Kliogest 2 mg/1 mg, filmomhulde tabletten
not available BE165462 NOVO NORDISK PHARMA SA BE
Kliogest 2 mg/1 mg comprimés pelliculés
not available BE165462 NOVO NORDISK PHARMA SA BE
Kliogest N 2 mg/1 mg Filmtabletten
not available 26118.00.00 NOVO NORDISK PHARMA GMBH
DE
Kliogest kalvopäällysteiset tabletit
not available 10575 NOVO NORDISK A/S FI
KLIOGEST, comprimé pelliculé
not available NL 15139 NOVO NORDISK FR
Kliogest, filmomhulde tabletten
not available RVG 14942 NOVO NORDISK B.V. NL
List of nationally authorised medicinal products EMA/811808/2017 Page 24/24
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
Kliogest, 2 mg + 1 mg, tabletki powlekane
not available R/3297 NOVO NORDISK A/S PL
Kliogest 2 mg/1 mg, comprimés pelliculés
not available 0642/03/12/7922 NOVO NORDISK PHARMA SA LU
Kliogest®, 2 mg + 1 mg, Comprimido revestido por película
not available 2280782 ISDIN LDA PT
