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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