11 January 2018 EMA/28116/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: chlorpromazine

Procedure no.: PSUSA/00000715/201705

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© 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

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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

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