8 February 2018 EMA/221190/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products Active substance(s): misoprostol (gastrointestinal indication)

Procedure No.: PSUSA/00010291/201706

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation

MRP/DCP Authorisation

National

MAH of product in the member

Member State

country)

number

Authorisation

state

where product is

Number Cytotec 200 microgram Tablets Cytotec 200 microgram tablets Cytotec 0,2 mg tabletter CYTOTEC 200 microgrammes, comprimé sécable CYTOTEC 200 microgram tabletten Cytotec 200 Mikrogramm Tabletten Misoprostol CYTOTEC 200 microgrammes, comprimés CYTOTEC 200 microgrammes, comprimés Cytotec 200 Mikrogramm Tabletten Cytotec 0,2 mg comprimidos Cytotec 0,2 mg tabletter Cytotec Cytotec 0,2 mg tabletti Cytotec, tabletter Cytotec, 200 μg, tabletki Cyprostol® - Tabletten

not not not not

Cytotec 0,2 mg comprimidos CYTOTEC 200 microgrammes, comprimé sécable CYTOTEC 200 mcg δισκία Cytotec®, tabletten 200 microgram Cytotec 200 microgramos comprimidos Cytotec 0,2 mg tabletter CYTOTEC 200 mcg compresse

not available not available

8628628 34009 328 785 8 1

not available not available not available not available not available

EMA/221190/2018

available available available available

not available not available

BE134093 2007079404

PFIZER HEALTHCARE IRELAND PFIZER LIMITED PFIZER OY PFIZER HOLDING FRANCE (S.C.A.) CONTINENTAL PHARMA, INC. CONTINENTAL PHARMA, INC.

not available

2007079404

CONTINENTAL PHARMA, INC.

LU

not available

BE134093

CONTINENTAL PHARMA, INC.

BE

not not not not not not not not

BE134093 8628636 00/8063 880109 10710 11978 R/2716 1-19557

BE PT NO IS FI DK PL AT

40410/07/19-5-2008 RVG 13724 58.403

CONTINENTAL PHARMA, INC. LABORATÓRIOS PFIZER, LDA. PFIZER AS PFIZER APS PFIZER OY PFIZER APS PFIZER EUROPE MA EEIG PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. LABORATÓRIOS PFIZER, LDA. PFIZER HOLDING FRANCE (S.C.A.) PFIZER HELLAS, A.E. PFIZER B.V. PFIZER, S.L.

11033 026488015

PFIZER AB CONTINENTAL PHARMA, INC.

SE IT

available available available available available available available available

PA 822/118/1 PL 00057/0956 10710 34009 328 786 4 2

authorised IE UK FI FR BE LU

PT FR GR NL ES

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