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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
An agency of the European Union
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
14 June 2019 EMA/347250/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: clindamycin
Procedure no.: PSUSA/00000795/201810
List of nationally authorised medicinal products EMA/347250/2019 Page 2/22
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
CLEOCIN 100 mg Ovulo Vaginale IE/H/0119/001 028535033 PFIZER ITALIA S.R.L. IT
CLEOCIN 2% Crema Vaginale not available 028535019 PFIZER ITALIA S.R.L. IT
CLEOCIN 2% Crema Vaginale not available 028535021 PFIZER ITALIA S.R.L. IT
Clindac Sandoz 450 mg - Filmtabletten
DE/H/1989/001 1-25479 SANDOZ GMBH AT
Clindac Sandoz 600 mg - Filmtabletten
DE/H/1989/002 1-25480 SANDOZ GMBH AT
ClindaHEXAL 450 mg Filmtabletten
DE/H/1989/001 58763.00.00 HEXAL AG DE
ClindaHEXAL 600 mg Filmtabletten
DE/H/1989/002 58763.01.00 HEXAL AG DE
Clinda-IPP 600 mg Filmtabletten 600 mg Clindamycin als Clindamycinhydrochlorid
not available 48536.00.00 MIP PHARMA GMBH DE
Clindamicina Kabi 150 mg/ml solución inyectable
DE/H/0963/001 70527 FRESENIUS KABI ESPAÑA S.A.U. ES
Clindamycin - 1 A Pharma® 450 mg Filmtabletten
DE/H/1991/001 58769.00.00 1 A PHARMA GMBH DE
Clindamycin - 1 A Pharma® 600 mg Filmtabletten
DE/H/1991/002 58769.01.00 1 A PHARMA GMBH DE
Clindamycin 150 mg capsules not available MA505/01903 PFIZER HELLAS, A.E. MT
Clindamycin 150 mg capsules not available PL 00057/0957 PFIZER LIMITED UK
List of nationally authorised medicinal products EMA/347250/2019 Page 3/22
Clindamycin 150 mg capsules not available PL 00057/0957 PFIZER LIMITED UK
Clindamycin 150 mg/ml solution for injection
DE/H/0963/001 PA 566/045/001 FRESENIUS KABI DEUTSCHLAND GMBH
IE
Clindamycin 1A Pharma 450 mg - Filmtabletten
AT/H/0267/001 1-25483 1A PHARMA GMBH AT
Clindamycin 1A Pharma 600 mg - Filmtabletten
AT/H/0267/002 1-25484 1A PHARMA GMBH AT
Clindamycin 300 mg capsules, hard UK/H/4176/002 PL 33155/0012 RIVOPHARM UK LTD UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 300 mg Capsules, Hard
not available PL 25298/0066 BROWN & BURK UK LIMITED UK
Clindamycin 600mg Hard Capsules PL/H/0573/003 PL 30306/0678 ACTAVIS GROUP PTC EHF. UK
Clindamycin 75 mg capsules not available PL 00057/0958 PFIZER LIMITED UK
Clindamycin 75 mg capsules not available PL 00057/0958 PFIZER LIMITED UK
List of nationally authorised medicinal products EMA/347250/2019 Page 4/22
Clindamycin AL 600 mg Hartkapseln
DE/H/5312/001 96141.00.00 ALIUD PHARMA GMBH DE
Clindamycin Aristo 450 mg Filmtabletten
AT/H/0267/001 58765.00.00 ARISTO PHARMA GMBH (ART 57) DE
Clindamycin Aristo 600 mg Filmtabletten
AT/H/0267/002 58765.01.00 ARISTO PHARMA GMBH (ART 57) DE
Clindamycin Fresenius Kabi 150 mg/ml injektioneste, liuos
DE/H/0963/001 24305 FRESENIUS KABI AB FI
Clindamycin hameln 150 mg/ml injektioneste, liuos
DE/H/0421/001 19171 HAMELN PHARMA PLUS GMBH FI
Clindamycin Kabi 150 mg/ml injekční roztok/koncentrát pro infuzní roztok
DE/H/0963/001 15/301/08-C FRESENIUS KABI S.R.O. CZ
Clindamycin Kabi 150 mg/ml Injektionslösung
DE/H/0963/001 38352.00.00 FRESENIUS KABI DEUTSCHLAND GMBH
DE
Clindamycin Kabi 150 mg/ml, Ενέσιμο διάλυμα
DE/H/0963/001 11620/27-1-2014 FRESENIUS KABI HELLAS A.E. GR
Clindamycin Kabi, 150 mg/ml, roztwór do wstrzykiwań
DE/H/0963/001 14645 FRESENIUS KABI POLSKA SP. Z O.O.
PL
Clindamycin MIP 600 mg filmdragerade tabletter
DE/H/346/003 17683 MIP PHARMA GMBH FI
Clindamycin MIP 600 mg tabletti, kalvopäällysteinen
DE/H/0346/003 17683 MIP PHARMA GMBH FI
Clindamycin Sandoz® 450 mg DE/H/1990/001 58767.00.00 HEXAL AG DE
List of nationally authorised medicinal products EMA/347250/2019 Page 5/22
Filmtabletten
Clindamycin Sandoz® 600 mg Filmtabletten
DE/H/1990/002 58767.01.00 HEXAL AG DE
Clindamycin STADA 600 mg Hartkapseln
DE/H/5312/001 137308 STADA ARZNEIMITTEL GMBH AT
Clindamycine 10 mg/ml Teva, oplossing voor cutaan gebruik
not available RVG 108315 TEVA NEDERLAND B.V. NL
Clindamycine CF 600 mg, harde capsules
DE/H/5312/001 RVG 118389 CENTRAFARM B.V. NL
Clindamycine EG 600 mg gélules DE/H/5312/001 BE502373 EUROGENERICS N.V./S.A. BE
Clindamycine EG 600 mg gélules DE/H/5312/001 2017070190 EUROGENERICS N.V./S.A. LU
Clindamycine EG 600 mg harde capsules
DE/H/5312/001 BE502373 EUROGENERICS N.V./S.A. BE
Clindamycine EG 600 mg Hartkapseln
DE/H/5312/001 BE502373 EUROGENERICS N.V./S.A. BE
Clindamycine Fresenius Kabi 150 mg/ml Injektionslösung
DE/H/0963/001 BE345134 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml Injektionslösung
DE/H/0963/001 BE345143 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml Injektionslösung
DE/H/0963/001 BE345125 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml oplossing voor injectie
DE/H/0963/001 BE345134 FRESENIUS KABI NV/SA BE
List of nationally authorised medicinal products EMA/347250/2019 Page 6/22
Clindamycine Fresenius Kabi 150 mg/ml oplossing voor injectie
DE/H/0963/001 BE345143 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml oplossing voor injectie
DE/H/0963/001 BE345125 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml oplossing voor injectie
DE/H/0963/001 RVG 101396 FRESENIUS KABI NEDERLAND B.V.
NL
Clindamycine Fresenius Kabi 150 mg/ml solution injectable
DE/H/0963/001 BE345134 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml solution injectable
DE/H/0963/001 BE345143 FRESENIUS KABI NV/SA BE
Clindamycine Fresenius Kabi 150 mg/ml solution injectable
DE/H/0963/001 BE345125 FRESENIUS KABI NV/SA BE
Clindamycine-hameln 150 mg/ml, oplossing voor injectie
DE/H/0421/001 RVG 30597 HAMELN PHARMA PLUS GMBH NL
Clindamycin-MIP 600 mg Filmtablette
DE/H/0346/003 42725.02.01 MIP PHARMA GMBH DE
Clindamycin-MIP 600 mg Filmtabletten
DE/H/0346/003 1-24972 MIP PHARMA AUSTRIA GMBH AT
Clindamycin-ratiopharm® 600 mg Filmtabletten
not available 42727.00.01 RATIOPHARM GMBH DE
Clinda-saar 600 mg Filmtablette Wirkstoff: Clindamycin
not available 40649.02.00 CHEPHASAAR CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
DE
Clindasol® 600 mg Filmtabletten not available 48537.00.00 CNP PHARMA GMBH DE
List of nationally authorised medicinal products EMA/347250/2019 Page 7/22
CLINWAS Gel tópico Clindamicina
not available 60362 CHIESI ESPAÑA S.A.U. ES
CLINWAS Solución tópica Clindamicina
not available 60361 CHIESI ESPAÑA S.A.U. ES
DALACIN – Lotion not available 1-20589 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
DALACIN – Vaginalcreme not available 1-20417 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin 10 mg emulsión cutánea not available 58.782 PFIZER, S.L. ES
Dalacin 10 mg solución cutánea not available 56.769 PFIZER, S.L. ES
Dalacin 10 mg/ml emulsio iholle not available 11433 PFIZER OY FI
Dalacin 10 mg/ml húðfleyti. not available 940045 PFIZER APS IS
Dalacin 10 mg/ml húðlausn. not available 822986 PFIZER APS IS
Dalacin 10 mg/ml külsőleges emulzió
not available OGYI-T-958/09 PFIZER KFT. HU
Dalacin 10 mg/ml külsőleges oldat not available OGYI-T-958/07 PFIZER KFT. HU
Dalacin 10 mg/ml külsőleges oldat not available OGYI-T-958/08 PFIZER KFT. HU
DALACIN 10 mg/ml kutan emulsion
not available 11433 PFIZER OY FI
Dalacin 10 mg/ml kutan emulsion not available 11472 PFIZER AB SE
Dalacin 10 mg/ml liniment, emulsjon
not available 7953 PFIZER AS NO
List of nationally authorised medicinal products EMA/347250/2019 Page 8/22
Dalacin 100 mg emätinpuikot IE/H/0119/001 31699 PFIZER OY FI
Dalacin 100 mg óvulos IE/H/0119/001 62.911 PFIZER, S.L. ES
Dalacin 100 mg Vaginal Ovule IE/H/0119/001 PA 822/119/1 PFIZER HEALTHCARE IRELAND IE
Dalacin 100 mg vaginālie supozitoriji
not available 03-0034 PFIZER EUROPE MA EEIG LV
Dalacin 100 mg vagitorier IE/H/0119/001 31699 PFIZER OY FI
Dalacin 100 mg vagitorier not available 99-3557 PFIZER AS NO
Dalacin 100 mg, vagitorier IE/H/0119/001 15429 PFIZER AB SE
Dalacin 15 mg/ml granulat til mikstur, oppløsning
not available 5970 PFIZER AS NO
Dalacin 15 mg/ml granulat till oral lösning
not available 6822 PFIZER OY FI
Dalacin 15 mg/ml granulat till oral lösning
not available 9235 PFIZER AB SE
DALACIN 15 mg/ml rakeet oraaliliuosta varten
not available 6822 PFIZER OY FI
Dalacin 150 mg cápsulas duras not available 49.152 PFIZER, S.L. ES
Dalacin 150 mg hörð hylki not available 691234 PFIZER APS IS
Dalacin 150 mg kapsel, hard not available 5696 PFIZER AS NO
DALACIN 150 mg kapseli not available 11591 PFIZER OY FI
DALACIN 150 mg kapslar not available 11591 PFIZER OY FI
List of nationally authorised medicinal products EMA/347250/2019 Page 9/22
Dalacin 150 mg kapslar, hårda not available 8969 PFIZER AB SE
Dalacin 150 mg kemény kapszula not available OGYI-T-958/02 PFIZER KFT. HU
Dalacin 150 mg kemény kapszula not available OGYI-T-958/01 PFIZER KFT. HU
Dalacin 150 mg/ml injeksjonsvæske, oppløsning
not available 6111 PFIZER AS NO
Dalacin 150 mg/ml injektionsvätska, lösning
not available 9178 PFIZER AB SE
Dalacin 150 mg/ml stungulyf, lausn not available 741748 PFIZER APS IS
DALACIN 2 % emätinemulsiovoide
not available 11508 PFIZER OY FI
Dalacin 2 % vaginalkräm not available 11773 PFIZER AB SE
Dalacin 2 % vaginalkräm not available 11773 PFIZER AB SE
Dalacin 2% Vaginal Cream not available PA 822/119/2 PFIZER HEALTHCARE IRELAND IE
Dalacin 2% vaginalkräm not available 11508 PFIZER OY FI
Dalacin 2% vaginalkrem not available 8078 PFIZER AS NO
Dalacin 20 mg/g crema vaginal not available 60.034 PFIZER, S.L. ES
Dalacin 20 mg/g hüvelykrém not available OGYI-T-958/10 PFIZER KFT. HU
Dalacin 20 mg/g krema za rodnicu not available UP/I-530-09/12-02/515 PFIZER CROATIA D.O.O. HR
Dalacin 20 mg/g skeiðarkrem. not available 930251 PFIZER APS IS
Dalacin 20 mg/g vaginālais krēms not available 98-0608 PFIZER EUROPE MA EEIG LV
DALACIN 20 mg/g vaginalna not available H/93/00439/003 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/347250/2019 Page 10/22
krema
Dalacin 300 mg cápsulas duras not available 58.783 PFIZER, S.L. ES
Dalacin 300 mg hörð hylki not available 940126 PFIZER APS IS
Dalacin 300 mg kapsel, hard not available 7362 PFIZER AS NO
DALACIN 300 mg kapseli not available 9647 PFIZER OY FI
DALACIN 300 mg kapslar not available 9647 PFIZER OY FI
Dalacin 300 mg kapslar, hårda not available 10525 PFIZER AB SE
Dalacin 300 mg kemény kapszula not available OGYI-T-958/03 PFIZER KFT. HU
Dalacin 75 mg kapsel, hard not available 5695 PFIZER AS NO
Dalacin 75 mg kapslar, hårda not available 8968 PFIZER AB SE
DALACIN C (κλινδαμυκίνη) not available 22890/9.05.03 PFIZER HELLAS, A.E. GR
DALACIN C (κλινδαμυκίνη) not available 21159/2.05.03 PFIZER HELLAS, A.E. GR
DALACIN C 150 mg Cápsulas not available 4644688 LABORATÓRIOS PFIZER, LDA. PT
DALACIN C 150 mg Cápsulas not available 8293431 LABORATÓRIOS PFIZER, LDA. PT
Dalacin C 150 mg Cápsulas not available 8293407 LABORATÓRIOS PFIZER, LDA. PT
DALACIN C 150 mg Cápsulas not available 4644589 LABORATÓRIOS PFIZER, LDA. PT
Dalacin C 150 mg capsule not available 10141/2017/01 PFIZER EUROPE MA EEIG RO
DALACIN C 150 mg capsule rigide not available 022633059 PFIZER ITALIA S.R.L. IT
Dalacin C 150 mg gélules not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg gélules not available BE061765 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/347250/2019 Page 11/22
Dalacin C 150 mg gélules not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg gélules not available 2009030221 PFIZER S.A. (BELGIUM) LU
Dalacin C 150 mg Hard Capsules not available PA 822/120/1 PFIZER HEALTHCARE IRELAND IE
Dalacin C 150 mg harde capsules not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg harde capsules not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg harde capsules not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg Hartkapseln not available 2009030221 PFIZER S.A. (BELGIUM) LU
Dalacin C 150 mg Hartkapseln Clindamycin
not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg Hartkapseln Clindamycin
not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg Hartkapseln Clindamycin
not available BE061765 PFIZER S.A. (BELGIUM) BE
Dalacin C 150 mg kapsulas not available 98-0397 PFIZER EUROPE MA EEIG LV
DALACIN C 150 mg kietosios kapsulės
not available LT/1/94/2047/001 PFIZER EUROPE MA EEIG LT
DALACIN C 150 mg tvrdé kapsuly not available 15/0166/72-C/S PFIZER EUROPE MA EEIG SK
DALACIN C 150 mg tvrdé tobolky not available 15/166/72-A/C PFIZER, SPOL. S R.O. CZ
Dalacin C 150 mg, capsules not available RVG 05871 PFIZER B.V. NL
DALACIN C 150 mg/ml injekční/ infuzní roztok
not available 15/111/74-C PFIZER, SPOL. S R.O. CZ
List of nationally authorised medicinal products EMA/347250/2019 Page 12/22
DALACIN C 150 mg/ml injekční/ infuzní roztok
not available 15/111/74-C PFIZER, SPOL. S R.O. CZ
DALACIN C 150 mg/ml injekční/ infuzní roztok
not available 15/111/74-C PFIZER, SPOL. S R.O. CZ
Dalacin C 150 mg/ml, oplossing voor injectie
not available RVG 06903 PFIZER B.V. NL
Dalacin C 300 mg capsule not available 10142/2017/01 PFIZER EUROPE MA EEIG RO
Dalacin C 300 mg gélules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg gélules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg gélules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg gélules not available 2009030222 PFIZER S.A. (BELGIUM) LU
Dalacin C 300 mg harde capsules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg harde capsules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg harde capsules not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg Hartkapseln Clindamycin
not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg Hartkapseln Clindamycin
not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg Hartkapseln Clindamycin
not available BE091122 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg Hartkapseln Clindamycin
not available 2009030222 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/347250/2019 Page 13/22
Dalacin C 300 mg Injektionslösung Clindamycin
not available BE092224 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg Injektionslösung Clindamycin
not available 2009030223 PFIZER S.A. (BELGIUM) LU
Dalacin C 300 mg kapsulas not available 98-0398 PFIZER EUROPE MA EEIG LV
DALACIN C 300 mg kapsule not available UP/I-530-09/12-02/514 PFIZER CROATIA D.O.O. HR
DALACIN C 300 mg kietosios kapsulės
not available LT/1/94/2047/002 PFIZER EUROPE MA EEIG LT
Dalacin C 300 mg oplossing voor injectie
not available BE092224 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg solution injectable
not available BE092224 PFIZER S.A. (BELGIUM) BE
Dalacin C 300 mg solution injectable
not available 2009030223 PFIZER S.A. (BELGIUM) LU
DALACIN C 300 mg tvrdé kapsuly not available 15/0282/18-S PFIZER EUROPE MA EEIG SK
DALACIN C 300 mg tvrdé tobolky not available 15/166/72-B/C PFIZER, SPOL. S R.O. CZ
Dalacin C 300 mg, capsules not available RVG 14457 PFIZER B.V. NL
Dalacin C 600 mg Injektionslösung Clindamycin
not available BE092215 PFIZER S.A. (BELGIUM) BE
Dalacin C 600 mg Injektionslösung Clindamycin
not available 2009030224 PFIZER S.A. (BELGIUM) LU
Dalacin C 600 mg oplossing voor injectie
not available BE092215 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/347250/2019 Page 14/22
Dalacin C 600 mg solution injectable
not available BE092215 PFIZER S.A. (BELGIUM) BE
Dalacin C 600 mg solution injectable
not available 2009030224 PFIZER S.A. (BELGIUM) LU
Dalacin C 600 mg/4 ml šķīdums injekcijām
not available 98-0610 PFIZER EUROPE MA EEIG LV
Dalacin C 75 mg /5 ml Granulat zur Herstellung einer Suspension zum Einnehmen
not available 2009030220 PFIZER S.A. (BELGIUM) LU
Dalacin C 75 mg /5 ml Granulat zur Herstellung einer Suspension zum Einnehmen Clindamycin
not available BE061862 PFIZER S.A. (BELGIUM) BE
Dalacin C 75 mg/5 ml granulaat voor orale suspensie
not available BE061862 PFIZER S.A. (BELGIUM) BE
DALACIN C 75 mg/5 ml granulát na sirup
not available 15/0716/92-C/S PFIZER EUROPE MA EEIG SK
Dalacin C 75 mg/5 ml granulés pour suspension buvable
not available BE061862 PFIZER S.A. (BELGIUM) BE
Dalacin C 75 mg/5 ml granulés pour suspension buvable
not available 2009030220 PFIZER S.A. (BELGIUM) LU
Dalacin C 75 mg/5 ml, granulaat voor orale suspensie
not available RVG 06354 PFIZER B.V. NL
Dalacin C 900 mg Injektionslösung Clindamycin
not available BE092206 PFIZER S.A. (BELGIUM) BE
List of nationally authorised medicinal products EMA/347250/2019 Page 15/22
Dalacin C 900 mg Injektionslösung Clindamycin
not available 2009030225 PFIZER S.A. (BELGIUM) LU
Dalacin C 900 mg oplossing voor injectie
not available BE092206 PFIZER S.A. (BELGIUM) BE
Dalacin C 900 mg solution injectable
not available BE092206 PFIZER S.A. (BELGIUM) BE
Dalacin C 900 mg solution injectable
not available 2009030225 PFIZER S.A. (BELGIUM) LU
Dalacin C Capsules 150 mg not available MA505/01903 PFIZER HELLAS, A.E. MT
Dalacin C Capsules 150 mg not available PL 00057/0957 PFIZER LIMITED UK
Dalacin C Capsules 150 mg not available PL 00057/0957 PFIZER LIMITED UK
Dalacin C Capsules 75 mg not available PL 00057/0958 PFIZER LIMITED UK
Dalacin C Capsules 75 mg not available PL 00057/0958 PFIZER LIMITED UK
DALACIN C FOSFATO 300 mg/2 ml soluzione iniettabile
not available 023868019 PFIZER ITALIA S.R.L. IT
DALACIN C FOSFATO 600 mg/4 ml soluzione iniettabile
not available 023868021 PFIZER ITALIA S.R.L. IT
Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for Injection, 2 ml
not available PA 822/120/2 PFIZER HEALTHCARE IRELAND IE
Dalacin C Phosphate 150 mg/ml Concentrate for Solution for Infusion or Solution for
not available PA 822/120/3 PFIZER HEALTHCARE IRELAND IE
List of nationally authorised medicinal products EMA/347250/2019 Page 16/22
Injection, 4 ml
Dalacin C Phosphate Sterile Solution
not available MA505/01902 PFIZER HELLAS, A.E. MT
Dalacin C Phosphate Sterile Solution
not available PL 00057/0959 PFIZER LIMITED UK
Dalacin C, 150 mg kõvakapslid not available 047094 PFIZER EUROPE MA EEIG EE
DALACIN C, 150 mg, kapsułki not available R/0712 PFIZER EUROPE MA EEIG PL
DALACIN C, 150 mg/ml, roztwór do wstrzykiwań i infuzji
not available R/0713 PFIZER EUROPE MA EEIG PL
Dalacin C, 300 mg kõvakapslid not available 047194 PFIZER EUROPE MA EEIG EE
DALACIN C, 300 mg, kapsułki not available R/3064 PFIZER EUROPE MA EEIG PL
DALACIN C, 75 mg, kapsułki not available R/0711 PFIZER EUROPE MA EEIG PL
DALACIN C, 75 mg/5 ml, granulat do sporządzania syropu
not available R/3450 PFIZER EUROPE MA EEIG PL
Dalacin C® 150 mg – Kapseln not available 1-16138 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin C® 300 mg – Kapseln not available 1-18937 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin C® 75 mg/5 ml – Granulat für orale Lösung
not available 1-16190 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin C® Phosphat 300 mg/2 ml – Ampulle
not available 1-16059 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
List of nationally authorised medicinal products EMA/347250/2019 Page 17/22
Dalacin C® Phosphat 600 mg/4 ml – Ampulle
not available 1-16060 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin C® Phosphat 900 mg/6 ml – Ampulle
not available 1-16061 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin Cream 2%. not available PL 00057/0960 PFIZER LIMITED UK
DALACIN C™ (Φωσφορική Κλινδαμυκίνη)
not available 21160/2.5.03 PFIZER HELLAS, A.E. GR
DALACIN C™ (Φωσφορική Κλινδαμυκίνη)
not available 21161/2.5.03 PFIZER HELLAS, A.E. GR
DALACIN C™ (Φωσφορική Κλινδαμυκίνη)
not available 22894/9.5.03 PFIZER HELLAS, A.E. GR
DALACIN T 1 % dermálna emulzia
not available 15/0411/92-C/S PFIZER EUROPE MA EEIG SK
DALACIN T 1 % dermálny roztok not available 15/0131/91-C/S PFIZER EUROPE MA EEIG SK
DALACIN T 1% emulsione cutanea
not available 025314030 PFIZER ITALIA S.R.L. IT
DALACIN T 1% gel not available 025314042 PFIZER ITALIA S.R.L. IT
DALACIN T 1% soluzione cutanea not available 025314016 PFIZER ITALIA S.R.L. IT
DALACIN T 10 mg/ml kožní roztok
not available 15/131/91-C PFIZER, SPOL. S R.O. CZ
Dalacin T 10 mg/ml šķīdums ārīgai lietošanai
not available 03-0466 PFIZER EUROPE MA EEIG LV
Dalacin T 10 mg/ml solução not available 8614305 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/347250/2019 Page 18/22
cutânea
Dalacin T 10 mg/ml solução cutânea
not available 8614313 LABORATÓRIOS PFIZER, LDA. PT
Dalacin T Topical 10 mg/ml Cutaneous Solution
not available PA 822/121/2 PFIZER HEALTHCARE IRELAND IE
Dalacin T Topical Lotion not available PL 00057/0961 PFIZER LIMITED UK
Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion.
not available PA0822/121/001 PFIZER HEALTHCARE IRELAND IE
DALACIN T, 10 mg/g (1%), żel not available 7491 PFIZER EUROPE MA EEIG PL
DALACIN T, 10 mg/ml nahalahus not available 239298 PFIZER EUROPE MA EEIG EE
DALACIN T, 10 mg/ml, emulsja na skórę
not available R/2910 PFIZER EUROPE MA EEIG PL
DALACIN T, 10 mg/ml, płyn na skórę
not available R/1464 PFIZER EUROPE MA EEIG PL
Dalacin Topical 1% Gel not available BE173144 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% gel not available BE173144 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% gel not available BE173144 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% Gel not available 2007069332 PFIZER S.A. (BELGIUM) LU
Dalacin Topical 1% gel not available 2007069332 PFIZER S.A. (BELGIUM) LU
Dalacin Topical 1% Lösung zur Anwendung auf der Haut
not available BE124257 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% Lösung zur not available 2007069333 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/347250/2019 Page 19/22
Anwendung auf der Haut
Dalacin Topical 1% oplossing voor cutaan gebruik
not available BE124257 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% solution pour application cutanée
not available BE124257 PFIZER S.A. (BELGIUM) BE
Dalacin Topical 1% solution pour application cutanée
not available 2007069333 PFIZER S.A. (BELGIUM) LU
DALACIN V 2 % vaginálny krém not available 15/0653/94-S PFIZER EUROPE MA EEIG SK
Dalacin V 20 mg/g creme vaginal not available 2311686 LABORATÓRIOS PFIZER, LDA. PT
DALACIN Vaginal 100 mg/5 g crème vaginale
not available BE165584 PFIZER S.A. (BELGIUM) BE
DALACIN Vaginal 100 mg/5 g crème vaginale
not available 2009030226 PFIZER S.A. (BELGIUM) LU
DALACIN Vaginal 100 mg/5 g crème voor vaginaal gebruik
not available BE165584 PFIZER S.A. (BELGIUM) BE
Dalacin Vaginal 100 mg/5 g Vaginalcreme
not available BE165584 PFIZER S.A. (BELGIUM) BE
Dalacin Vaginal 100 mg/5 g Vaginalcreme
not available 2009030226 PFIZER S.A. (BELGIUM) LU
DALACIN vaginální krém not available 54/360/93-C PFIZER, SPOL. S R.O. CZ
Dalacin, 100 mg vaginaalsuposiidid not available 352101 PFIZER EUROPE MA EEIG EE
DALACIN, 20 mg/g (2%), krem dopochwowy
not available R/7131 PFIZER EUROPE MA EEIG PL
List of nationally authorised medicinal products EMA/347250/2019 Page 20/22
Dalacin, injektionsvæske, opløsning not available 06418 PFIZER APS DK
Dalacin, kapsler, hårde not available 14545 PFIZER APS DK
Dalacin, kapsler, hårde not available 05900 PFIZER APS DK
Dalacin, kutanemulsion not available 13322 PFIZER APS DK
Dalacin, kutanopløsning not available 11032 PFIZER APS DK
Dalacin, vaginalcreme not available 15541 PFIZER APS DK
DALACIN® – Lösung zur äußerlichen Anwendung
not available 1-18361 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
AT
Dalacin® T Topical Solution not available MA505/01901 PFIZER HELLAS, A.E. MT
Dalacin® T Topical Solution not available PL 00057/0962 PFIZER LIMITED UK
DALACIN-C™ Κολπική Κρέμα 2%
not available 21162/2.5.2003 PFIZER HELLAS, A.E. GR
DALACINE 150 mg, gélule not available 34009 553 941 3 6 PFIZER HOLDING FRANCE FR
DALACINE 150 mg, gélule not available 34009 306 681 5 3 PFIZER HOLDING FRANCE FR
DALACINE 150 mg, gélule not available 34009 550 298 3 0 PFIZER HOLDING FRANCE FR
DALACINE 300 mg, gélule not available 34009 341 036 5 0 PFIZER HOLDING FRANCE FR
DALACINE 300 mg, gélule not available 34009 550 298 4 7 PFIZER HOLDING FRANCE FR
DALACINE 75 mg, gélule not available 34009 306 680 9 2 PFIZER HOLDING FRANCE FR
DALACINE 75 mg, gélule not available 34009 553 940 7 5 PFIZER HOLDING FRANCE FR
DALACINE T TOPIC, solution pour application cutanée
not available 34009 326 570 4 9 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/347250/2019 Page 21/22
DALACINE T TOPIC, solution pour application cutanée
not available 34009 326 569 6 7 PFIZER HOLDING FRANCE FR
DALACINE® 600 mg, solution injectable
not available 34009 561 977.3 6 PFIZER HOLDING FRANCE FR
DALACINE® 900 mg, solution injectable
not available 34009 561 976 7 5 PFIZER HOLDING FRANCE FR
Dalacin-T 10 mg/ml, vloeistof voor cutaan gebruik
not available RVG 09728 PFIZER B.V. NL
Dalacin-T 10 mg/ml, vloeistof voor cutaan gebruik
not available RVG 09728 PFIZER B.V. NL
Klimicin 150 mg kemény kapszula not available OGYI-T-6317/04 LEK PHARMACEUTICALS D.D. LJUBLJANA
HU
Klirreo, 600 mg, kapsułki, twarde PL/H/0573/003 23291 ACTAVIS GROUP PTC EHF. PL
Sobelin® 100 mg Vaginalzäpfchen IE/H/0119/001 90615.00.00 PFIZER PHARMA PFE GMBH DE
Sobelin® 150 mg, Hartkapseln not available 6888.01.00 PFIZER PHARMA PFE GMBH DE
Sobelin® 300 mg, Hartkapseln not available 6888.02.00 PFIZER PHARMA PFE GMBH DE
Sobelin® 75 mg, Hartkapseln not available 6888.00.00 PFIZER PHARMA PFE GMBH DE
Sobelin® Granulat 75 mg/5 ml, Granulat zur Herstellung einer Lösung zum Einnehmen
not available 6888.00.01 PFIZER PHARMA PFE GMBH DE
Sobelin® Solubile 600 600 mg/4 ml, Injektionslösung/ Konzentrat zur Herstellung einer
not available 6892.01.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/347250/2019 Page 22/22
Infusionslösung
Sobelin® Vaginalcreme 20 mg/g not available 28680.00.00 PFIZER PHARMA PFE GMBH DE
ZINDACLIN® l%Gel UK/H/0503/001 66.610 INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.
ES
Далацин 2% вагинален крем not available 20040015 PFIZER EUROPE MA EEIG BG
Далацин C 150 mg твърди капсули
not available 20030574 PFIZER EUROPE MA EEIG BG
Далацин C 150 mg/ml инжекционен разтвор
not available 20030573 PFIZER EUROPE MA EEIG BG
Далацин C 150 mg/ml инжекционен разтвор
not available 20030573 PFIZER EUROPE MA EEIG BG
Далацин C 300 mg твърди капсули
not available 20030575 PFIZER EUROPE MA EEIG BG
Далацин T 10 mg/ml разтвор за кожа
not available 20040152 PFIZER EUROPE MA EEIG BG
Клиндамицин АБР 600 mg твърди капсули
not available 20140095 ANTIBIOTIC-RAZGRAD AD BG
Клиндамицин Каби 150 mg/ml инжекционен разтвор
DE/H/0963/001 20080098 FRESENIUS KABI BULGARIA EOOD
BG