21 June 2017 EMA/PRAC/343350/2017

Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): baclofen (oral)

Procedure No.: PSUSA/00000294/201609

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation

MRP/DCP

National Authorisation

MAH of product in the

Member State where

country)

Authorisation number

Number

member state

product is authorised

Lioresal 10 mg Tabletten Lioresal 25 mg Tabletten LIORESAL 25 MG COMPRIMATE LIORESAL 10 MG COMPRIMATE Lioresal 10 mg tablete Lioresal 25 mg tablete Lioresal 10 mg Tabletten Lioresal 25 mg Tabletten Lioresal® Liquid

not not not not not not not not not

BE051021 BE051012 6381/2014/01 6380/2014/01 UP/I-530-09/11-02/617 UP/I-530-09/11-02/618 0010/93/05/2445 0010/93/05/2446 PL 00101/0503

BE BE RO RO HR HR LU LU UK

LIORESAL 10 mg compresse Lioresal 10 mg comprimidos

not available not available

022999015 9319822

Lioresal 10 mg comprimidos

not available

9319830

LIORESAL 25 mg compresse Lioresal 25 mg comprimidos

not available not available

022999027 9319855

LIORESAL 10 mg comprimidos Lioresal 10 mg tabletter Lioresal 10 mg tabletti LIORESAL 25 mg comprimidos Lioresal 25 mg tabletter Lioresal 25 mg tabletti Lioresal Lioresal Lioresal LIORESAL® 10, 10 MG TABLETTEN Lioresal 10 mg tabletta

not not not not not not not not not not not

available available available available available available available available available available available

52180 6384 6384 52.181 6385 6385 06074 10006 13151 6078226.01.00 OGYI-T-842/01

Lioresal 10, tabletten 10 mg Lioresal® 25, 25 mg Tabletten Lioresal 25 mg tabletta

not available not available not available

RVG 06347 6078226.02.00 OGYI-T-842/02

NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA GMBH NOVARTIS PHARMA GMBH NOVARTIS HRVATSKA D.O.O. NOVARTIS HRVATSKA D.O.O. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS FARMA S.P.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMA S.P.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMACÉUTICA S.A. NOVARTIS FINLAND OY NOVARTIS FINLAND OY NOVARTIS FARMACÉUTICA S.A. NOVARTIS FINLAND OY NOVARTIS FINLAND OY NOVARTIS HEALTHCARE A/S NOVARTIS HEALTHCARE A/S NOVARTIS HEALTHCARE A/S NOVARTIS PHARMA GMBH NOVARTIS HUNGÁRIA KFT. PHARMA NOVARTIS PHARMA B.V. NOVARTIS PHARMA GMBH NOVARTIS HUNGÁRIA KFT. PHARMA

EMA/PRAC/343350/2017

available available available available available available available available available

IT PT PT IT PT ES FI FI ES FI FI DK DK DK DE HU NL DE HU

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Product Name (in authorisation

MRP/DCP

National Authorisation

MAH of product in the

Member State where

country)

Authorisation number

Number

member state

product is authorised

Lioresal 25, tabletten 25 mg Lioresal® 5, 5 mg Tabletten Lioresal 5, tabletten 5 mg Lioresal® Tablets 10mg

not not not not

available available available available

RVG 06348 6078226.00.00 RVG 09086 PL 00101/0504

NL DE NL UK

Lioresal 10 mg - Tabletten Lioresal 10 mg comprimés LIORESAL 10 MG COMPRIMÉS Lioresal 10 mg tabletten Lioresal 10 mg tabletter LIORESAL 10 mg, comprimé sécable Lioresal 25 mg - Tabletten Lioresal 25 mg comprimés Lioresal 25 mg comprimés Lioresal 25 mg tabletten Lioresal 25 mg tabletter LIORESAL 10 MG TABLETS

not not not not not not not not not not not not

available available available available available available available available available available available available

14892 BE051021 0010/93/05/2445 BE051021 8869 3400931716181 14893 BE051012 0010/93/05/2446 BE051012 08870-0 PA 13/58/1

Lioresal 5mg/5ml Oral Solution

not available

PA 13/58/2

Lioresal 25 mg töflur Lioresal 10 mg tabletter Lioresal 25 mg tabletter

not available not available not available

772127 5725 5726

NOVARTIS PHARMA B.V. NOVARTIS PHARMA GMBH NOVARTIS PHARMA B.V. NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMA GMBH NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS SVERIGE AB NOVARTIS PHARMA S.A.S. NOVARTIS PHARMA GMBH NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS SVERIGE AB NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS HEALTHCARE A/S NOVARTIS NORGE AS NOVARTIS NORGE AS

BACLOFEN-POLPHARMA 10 mg tablety

not available

63/102/81-A/C

CZ

Baclofen 5mg/5ml Oral Solution

not available

PL 20416/0193

ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA CRESCENT PHARMA LIMITED

EMA/PRAC/343350/2017

AT BE LU BE SE FR AT BE LU BE SE IE IE IS NO NO

UK

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