14 April 2016 EMA/346553/2016 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: influenza vaccine (surface antigen, inactivated, adjuvanted)

Procedure no.: PSUSA/00010300/201508

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, 2016. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Chiromas

IT/H/0104/001

63.566

Novartis Vaccines Influenza

Spain

S.R.L. Fluad

IT/H/0104/001

59/004/04-C

Novartis Vaccines Influenza

Czech Republic

S.R.L. Fluad

Fluad

IT/H/0104/001

IT/H/0104/001

031840034 $ 031840046

Novartis Vaccines Influenza

$ 031840059 $ 031840061

S.R.L.

16064

Novartis Vaccines Influenza

Italy

Sweden

S.R.L. Fluad

IT/H/0104/001

2-00250

Novartis Vaccines Influenza

Austria

S.R.L. Fluad

IT/H/0104/001

2477001

Gsk Vaccines S.R.L.

Greece

Fluad

IT/H/0104/001

31292

Novartis Vaccines Influenza

Denmark

S.R.L. Fluad

Fluad

IT/H/0104/001

IT/H/0104/001

3292083 $ 3559382 $ 5740782

Novartis Vaccines Influenza

$ 5740881

S.R.L.

2000110030

Novartis Vaccines Influenza

Portugal

Luxembourg

S.R.L. Fluad

IT/H/0104/001

BE218827

Novartis Vaccines Influenza

Belgium

S.R.L.

List of nationally authorised medicinal products EMA/346553/2016

Page 2/3

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Fluad

IT/H/0104/001

PA2032/002/001

Novartis Vaccines Influenza

Ireland

S.R.L. Fluad

IT/H/0104/001

PEI.H.01444.01.1

Novartis Vaccines Influenza

Germany

S.R.L.

List of nationally authorised medicinal products EMA/346553/2016

Page 3/3

Active substance: influenza vaccine (surface antigen, inactivated ...

Apr 14, 2016 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of ... Procedure Management and Committees Support.
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