PSUSA/00000295/201712 - European Medicines Agency - Europa EU

12 July 2018 EMA/488816/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: bambuterol

Procedure no.: PSUSA/00000295/201712

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 (in

MRP/DCP

MAH of product in the

Member State where

authorisation country)

Authorisation

member state

product is authorised

PL 17901/0103 11261 11260 NL 18 529

ASTRAZENECA ASTRAZENECA ASTRAZENECA ASTRAZENECA

UK LIMITED AB AB S.A.S.

UK SE SE FR

not available

1-19970

OSTERREICH

AT

not available not available not available

PL 17901/0104 13757 NL 18 530

ASTRAZENECA GMBH ASTRAZENECA ASTRAZENECA ASTRAZENECA

UK LIMITED A/S S.A.S.

UK DK FR

not available

23843.00.00

ASTRAZENECA GMBH

DE

not available

59.896

ES

not available not available

890188 (IS) 94-789

ASTRAZENECA FARMACÉUTICA SPAIN, S.A. ASTRAZENECA A/S ASTRAZENECA AS

National Authorisation Number

number Bambec Tablets 10 mg Bambec 20 mg tabletter Bambec 10 mg tabletter OXEOL® 10 mg, comprimé sécable Bambec 10 mg Tabletten Bambec Tablets 20 mg Bambec, tabletter OXEOL® 20 mg, comprimé sécable Bambec® 10 mg Tabletten Bambec 10 mg comprimidos Bambec 10 mg töflur. Bambec 10 mg tablett

not not not not

available available available available

List of nationally authorised medicinal products EMA/488816/2018

IS NO

Page 2/2