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List of nationally authorised medicinal products - European Medicines ...
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Jan 11, 2018 - LARGACTIL not available. PL 04425/0582. AVENTIS PHARMA LTD. UK. LARGACTIL 100 mg, comprimé pelliculé sÃ
11 January 2018 EMA/28116/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: chlorpromazine
Procedure no.: PSUSA/00000715/201705
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
LARGACTIL 4 POUR CENT, solution buvable en gouttes LARGACTIL 4 POUR CENT, solution buvable en gouttes LARGACTIL 4 POUR CENT, solution buvable en gouttes Largactil 40 mg/ml gotas orales en solución Largactil 5 mg/ml solución inyectable LARGACTIL 25 mg/5 ml, solution injectable en ampoule LARGACTIL 25 mg/5 ml, solution injectable en ampoule LARGACTIL 25 mg/5 ml, solution injectable en ampoule LARGACTIL
not available
305 714-7
SANOFI-AVENTIS FRANCE
FR
not available
550 056-9
SANOFI-AVENTIS FRANCE
FR
not available
305 713-0
SANOFI-AVENTIS FRANCE
FR
not available
23.661
SANOFI-AVENTIS, S.A.
ES
not available
19.622
SANOFI-AVENTIS, S.A.
ES
not available
305 709-3
SANOFI-AVENTIS FRANCE
FR
not available
550 067-0
SANOFI-AVENTIS FRANCE
FR
not available
327 224-2
SANOFI-AVENTIS FRANCE
FR
not available
PL 04425/0582
AVENTIS PHARMA LTD
UK
LARGACTIL
not available
PL 04425/0582
AVENTIS PHARMA LTD
UK
LARGACTIL 100 mg, comprimé pelliculé sécable LARGACTIL 25 mg, comprimé pelliculé sécable Largactil 100 mg comprimidos recubiertos con película LARGACTIL 100 mg, comprimé pelliculé sécable Largactil 25 mg comprimidos recubiertos con película Prozin 40 mg/ml gocce orali, soluzione Prozin 100 mg compresse rivestite
not available
305 712-4
SANOFI-AVENTIS FRANCE
FR
not available
305 711-8
SANOFI-AVENTIS FRANCE
FR
not available
42934
SANOFI-AVENTIS, S.A.
ES
not available
550 058-1
SANOFI-AVENTIS FRANCE
FR
not available
23665
SANOFI-AVENTIS, S.A.
ES
not available
010852034
IT
not available
010852046
ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A.
List of nationally authorised medicinal products EMA/28116/2018
IT
Page 2/3
Product Name
MRP/DCP Authorisation
National Authorisation
MAH of product in the
Member State where
(in authorisation country)
Number
Number
Member State
product is authorised
Prozin 50 mg/2 ml soluzione iniettabile Prozin 25 mg compresse rivestite Chlorpromazine 50mg Tablets
not available
010852010
IT
not available
010852022
not available
PL 12762/0109
Chlorpromazine 25mg Tablets
not available
PL 12762/0108
LARGACTIL® 25 mg compresse rivestite con film LARGACTIL® 100 mg compresse rivestite con film LARGACTIL® 50 mg/2 ml soluzione iniettabile Chlorpromazine 100 mg Tablets
not available
007899026
ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. MERCURY PHARMACEUTICALS LTD. MERCURY PHARMACEUTICALS LTD. TEOFARMA S.R.L.
not available
007899038
TEOFARMA S.R.L.
IT
not available
007899014
TEOFARMA S.R.L.
IT
not available
PL 12762/0110
MERCURY PHARMACEUTICALS LTD.
UK
List of nationally authorised medicinal products EMA/28116/2018
IT UK UK IT
Page 3/3
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