30 May 2018 EMA/475011/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: famotidine

Procedure no.: PSUSA/00001350/201709

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

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Pepcid 10 mg kalvopäällysteiset

not available

11751

MCNEIL, A DIVISION OF

FI

tabletit

JANSSEN-CILAG OY

Pepcid tabletter 10 mg

not available

8250

MCNEIL SWEDEN AB

NO

Pepcid 10 mg comprimidos

not available

62.090

JOHNSON & JOHNSON S.A.

ES

not available

PA 823/64/1

MCNEIL HEALTHCARE

IE

recubiertos Pepcid AC

(IRELAND) LIMITED Pepcid 10 mg filmdragerade

not available

12017

MCNEIL SWEDEN AB

SE

not available

11751

MCNEIL, A DIVISION OF

FI

tabletter Pepcid 10 mg kalvopäällysteiset tabletit Pepcid 10 mg kalvopäällysteiset

JANSSEN-CILAG OY not available

11751

tabletit Pepcid 10 mg comprimidos

MCNEIL, A DIVISION OF

FI

JANSSEN-CILAG OY not available

62.090

JOHNSON & JOHNSON S.A.

ES

not available

PA 823/64/1

MCNEIL HEALTHCARE

IE

recubiertos Pepcid AC

(IRELAND) LIMITED Pepcid AC

not available

PA 823/64/1

MCNEIL HEALTHCARE

IE

Pepcid 10 mg filmdragerade

not available

12017

MCNEIL SWEDEN AB

SE

not available

12017

MCNEIL SWEDEN AB

SE

not available

11751

MCNEIL, A DIVISION OF

FI

(IRELAND) LIMITED tabletter Pepcid 10 mg filmdragerade tabletter Pepcid 10 mg filmdragerad tablett Pepcid 10 mg filmdragerad

JANSSEN-CILAG OY not available

11751

tablett Pepcid 10 mg filmdragerad

MCNEIL, A DIVISION OF

FI

JANSSEN-CILAG OY not available

tablett List of nationally authorised medicinal products EMA/475011/2018

11751

MCNEIL, A DIVISION OF

FI

JANSSEN-CILAG OY

Page 2/3

Product Name (in

MRP/DCP Authorisation

National Authorisation

MAH of product in the

Member State where

authorisation country)

number

Number

member state

product is authorised

Famotidin Interpharm 40 mg -

not available

1-21642

INTERPHARM PRODUKTIONS

AT

Filmtabletten

GMBH

Ulcusan® 20 mg - Filmtabletten

not available

1-19673

KWIZDA PHARMA GMBH

AT

Ulcusan® 40 mg - Filmtabletten

not available

Ulcusan 20 mg/ml

not available

1-19672

KWIZDA PHARMA GMBH

AT

1-20056

KWIZDA PHARMA GMBH

AT

PEPTAN F.C.TAB 20MG

not available

26782

VIANEX S.A.

GR

PEPTAN F.C.TAB 40MG

not available

73819

VIANEX S.A.

GR

PEPTAN rapid sol. tab επιγλώσσιο

not available

73820

VIANEX S.A.

GR

not available

73821

VIANEX S.A.

GR

Pepdul mite 20 mg Filmtabletten

not available

5775.00.00

TEOFARMA S.R.L.

DE

Pepdul 40 mg Filmtabletten

not available

5775.01.00

TEOFARMA S.R.L.

DE

not available

PL 11311/0477

TILLOMED LABORATORIES

UK

Trockenstechampullen mit Lösungsmittel

δισκίο 20mg/TAB PEPTAN rapid sol. tab επιγλώσσιο δισκίο 40mg/TAB

Wirkstoff: Famotidin Famotidine 20mg Tablets

LTD Famotidine 40mg Tablets

not available

PL 11311/0478

TILLOMED LABORATORIES

UK

LTD

List of nationally authorised medicinal products EMA/475011/2018

Page 3/3

famotidine PSUSA-00001350-201709 - variation - European ...

May 30, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 ...

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