30 November 2017 EMA/776067/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products Active substance(s): fenspiride

Procedure No.: PSUSA/00001368/201704

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

Product Name (in

MRP/DCP

National Authorisation

MAH of product in the

Member State where

authorisation country)

Authorisation number

Number

member state

product is authorised

EPISTAT 80 mg comprimate cu eliberare prelungită EPISTAT 80 mg comprimate cu eliberare prelungită EPISTAT 80 mg comprimate cu eliberare prelungită Eurefin, 2 mg/ml, syrop Eurespal 2 mg/ml sirop

not available

9493/2016/01

GEDEON RICHTER ROMÂNIA S.A.

RO

not available

9493/2016/02

GEDEON RICHTER ROMÂNIA S.A.

RO

not available

9493/2016/03

GEDEON RICHTER ROMÂNIA S.A.

RO

not available not available

21095 1198/2008/01

PL RO

EURESPAL 80 mg comprimate cu eliberare prelungită EURESPAL 80 mg tabletki powlekane Fenspogal, 2 mg/ml, syrop

not available

667/2008/01

HASCO-LEK LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES)

not available

7481

LES LABORATOIRES SERVIER

PL

not available

15970

FARMACEUTYCZNA SPOLDZIELNIA PRACY GALENA

PL

Fosidal o smaku malinowym, 2 mg/ml, syrop Fosidal o smaku pomarańczowym, 2 mg/ml, syrop Fosidal PPH, 80 mg, tabletki powlekane

PL/H/0302/001

22566

MEDANA PHARMA SPOLKA AKCYJNA

PL

not available

18233

PL

not available

18821

Kudorp 2 mg/ml sirupas

PL/H/0302/001

LT/1/15/3728/001

Kudorp 2 mg/ml sīrups

PL/H/0302/001

15-0063

PNEUMOREL 0.2 POUR

not available

313 797.5

ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA MEDANA PHARMA SPOLKA AKCYJNA MEDANA PHARMA SPOLKA AKCYJNA LES LABORATOIRES SERVIER

RO

PL LT LV FR

List of nationally authorised medicinal productsPRAC PSUR AR template – NAPs only EMA/PRAC/776067/2017 Page 2/4

Product Name (in

MRP/DCP

National Authorisation

MAH of product in the

Member State where

authorisation country)

Authorisation number

Number

member state

product is authorised

not available

313 798.1

not available

313 799.8

not available

9435420

PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé PNEUMOREL 80MG, comprimé enrobé Pneumorel Retard 80 mg Comprimido gastrorresistente Pulneo, 2 mg/ml, syrop

not available

319 295.1

not available

319 299.7

not available

319 297.4

not available

319 298.0

not available

319 296.8

not available

319 300.5

not available

319 294.5

not available

319 301.1

not available

9435313

not available

15187

Pulneo, 25 mg/ml, krople doustne, roztwór Pulneo, 25 mg/ml, krople doustne, roztwór ЕУРЕСПАЛ 0,2% сироп

not available

18107

not available

18107

not available

20030278

ЕУРЕСПАЛ 80 mg таблетки с удължено освобождаване

not available

20030279

CENT, sirop PNEUMOREL 0.2 POUR CENT, sirop PNEUMOREL 0.2 POUR CENT, sirop Pneumorel 2 mg/ml Xarope

(SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) SERVIER PORTUGAL, ESPECIALIDADES FARMACÊUTICAS, LDA. LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES) SERVIER PORTUGAL, ESPECIALIDADES FARMACÊUTICAS, LDA. AFLOFARM FARMACJA POLSKA SP. Z O.O. AFLOFARM FARMACJA POLSKA SP. Z O.O. AFLOFARM FARMACJA POLSKA SP. Z O.O. LES LABORATOIRES SERVIER (SURESNES) LES LABORATOIRES SERVIER (SURESNES)

FR FR PT FR FR FR FR FR FR FR FR PT PL PL PL BG BG

Product Name (in

MRP/DCP

National Authorisation

MAH of product in the

Member State where

authorisation country)

Authorisation number

Number

member state

product is authorised

Сиресп 2 mg/ml сироп

PL/H/0302/001

20150296

MEDANA PHARMA SPOLKA AKCYJNA

BG

fenspiride PSUSA-1368-201704 - AR

Page 1. Page 2. prelungită prelungită prelungită prelungită pomarańczowym, 2. Kudorp 2 mg/ml sīrups. Page 3. ЕУРЕСПАЛ 0,2% сироп. ЕУРЕСПАЛ 80 mg.
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