29 September 2016 EMA/751375/2016 Procedure Management and Committees Support

List of nationally authorised medicinal products Active substance(s): gabapentin Procedure No.: PSUSA/00001499/201602

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

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© 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

PL 21880/0075 & PL 21880/0076 & PL 21880/0077

Medreich Plc

United Kingdom

41673

Aurobindo Pharma Limited

Denmark

Gabapentine Teva

NL32812

Teva Santé

France

Neurontin

72239.00.00 HR-H-198579675 & HR-H-227912224 & HR-H325649472

Pfizer Pharma Gmbh

Germany

Gabapentin Medreich Gabapentin ”aurobindo”

UK/H/1165/001

Neurontin

Pfizer Croatia D.O.O.

Croatia

Neurontin

DE/H/0899/001

34009 337 898 6 2

Pfizer Holding France (S.C.A.)

France

Neurontin

DE/H/0899/001 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003

RVG 22481

Pfizer B.V.

Netherlands

00-2995 & 8220

Pfizer As

Norway

0194/03097716 & 0194/03097717

Pfizer S.A. (Belgium)

Luxembourg

21/461/97-C & 21/462/97-C

Pfizer, Spol. S R.O.

Czech Republic

920269 (IS) & IS/1/01/119/01

Pfizer Aps

Iceland

MA505/04601 & MA505/04602

Pfizer Hellas, A.E.

Malta

PA 0822/015/001 & PA 0822/015/002

Pfizer Healthcare Ireland

Ireland

01-0276 & 01-0277 & 01-0278 0194/03097716 & 0194/03097717 & 0194/09030268 & 2009030266 & 2009030267 & 2009030268

Pfizer Limited

Latvia

Pfizer S.A. (Belgium)

Luxembourg

028740013 & 028740025 & 028740037

Pfizer Italia S.R.L.

Italy

12058 & 12059 & 12072

Pfizer Ab

Sweden

21/0070/97-S & 21/0393/08–S & 21/0394/08-S

Pfizer Limited

Slovakia

Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin

List of nationally authorised medicinal products EMA/751375/2016 Page 2/7

Product Name (in authorisation country)

MRP/DCP Authorisation number

Neurontin

DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003

Neurontin

DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003

Neurontin

DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003

Neurontin Neurontin Neurontin

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Laboratórios Pfizer, Lda.

Portugal

Pfizer Holding France (S.C.A.)

France

47275.00.00 & 47275.01.00 & 47275.02.00

Pfizer Pharma Gmbh

Germany

BE181133 & BE181142 & BE181151 H/99/01105/001 & H/99/01105/002 & H/99/01105/003 & H/99/01105/004 & H/99/01105/005 & H/99/01105/006 & H/99/01105/007 & H/99/01105/008 & H/99/01105/009 & H/99/01105/010 & H/99/01105/011 & H/99/01105/012 & H/99/01105/013 & H/99/01105/014 & H/99/01105/015 & H/99/01105/016 & H/99/01105/017 & H/99/01105/018 & H/99/01105/019 & H/99/01105/020 & H/99/01105/021 & H/99/01105/022 & H/99/01105/023 & H/99/01105/024 & H/99/01105/025 & H/99/01105/026 & H/99/01105/027 & H/99/01105/028 & H/99/01105/029 & H/99/01105/030 & H/99/01105/031 & H/99/01105/032 & H/99/01105/033 LT/1/08/1297/001 & LT/1/08/1297/002 & LT/1/08/1297/004 & LT/1/08/1297/005 & LT/1/08/1297/006 & LT/1/08/1297/007 & LT/1/08/1297/008 & LT/1/08/1297/009 & LT/1/08/1297/010 & LT/1/08/1297/011 & LT/1/08/1297/012 & LT/1/08/1297/013 & LT/1/08/1297/014 & LT/1/08/1297/015 & LT/1/08/1297/016 & LT/1/08/1297/017 & LT/1/08/1297/018 & LT/1/08/1297/019 & LT/1/08/1297/020 & LT/1/08/1297/021 & LT/1/08/1297/022 & LT/1/08/1297/023 &

Pfizer S.A. (Belgium)

Belgium

Pfizer Luxembourg Sarl

Slovenia

Pfizer Limited

Lithuania

2433084 & 2433183 & 2433282 & 2433381 & 3669587 & 5815584 & 5815683 & 5815782 34009 337 896 3 3 & 34009 337 900 0 4 & 34009 337 901 7 2 & 34009 337 904 6 2 & 34009 338 014 41

Product Name (in authorisation country)

MAH of product in the member state

Member State where product is authorised

Pfizer Kft.

Hungary

PL 00057/0536 & PL 00057/0537 & PL 00057/0853

Pfizer Limited

United Kingdom

LT/1/08/1297/003 & LT/1/08/1297/024

Pfizer Limited

Lithuania

212298

Estonia

1-20678 & 1-20679

Pfizer Europe Ma Eeig Pfizer Corporation Austria Gesellschaft M.B.H.

11662 & 11663

Pfizer Oy

Finland

17445 & 17446

Pfizer Hellas, A.E.

Cyprus

26441/9-4-2009 & 26442/9-4-2009

Pfizer Hellas, A.E.

Greece

32061 & 32062

Pfizer Aps

Denmark

60.621 & 60.622

Parke-Davis, S.L.

Spain

Neurontin

DE/H/0899/002 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003 DE/H/0899/002 & DE/H/0899/003

RVG 22482 & RVG 22483

Pfizer B.V.

Netherlands

Neurontin

DE/H/0899/003

0194/09030268

Pfizer S.A. (Belgium)

Luxembourg

Neurontin

DE/H/0899/003

21/463/97-C

Pfizer, Spol. S R.O.

Czech Republic

Neurontin

DE/H/0899/003

8221

Pfizer As

Norway

Neurontin

DE/H/0899/003

920270 (IS)

Pfizer Aps

Iceland

Neurontin

DE/H/0899/003

PA 822/15/3

Pfizer Healthcare Ireland

Ireland

Neurontin

OGYI-T-4966/08 & OGYI-T-4966/12

Pfizer Kft.

Hungary

0194/03097719 & 0194/03097720 0194/03097719 & 0194/03097720 & 2009030269 & 2009030270

Pfizer S.A. (Belgium)

Luxembourg

Neurontin

DE/H/0899/004 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005

Pfizer S.A. (Belgium)

Luxembourg

Neurontin

DE/H/0899/004 &

03-0016 & 03-0017

Pfizer Limited

Latvia

Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin

Neurontin

MRP/DCP Authorisation number

DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/002 & DE/H/0899/003 DE/H/0899/001 & DE/H/0899/003

National Authorisation Number

LT/1/08/1297/025 & LT/1/08/1297/026 & LT/1/08/1297/027 & LT/1/08/1297/028 & LT/1/08/1297/029 & LT/1/08/1297/030 OGYI-T-4966/01 & OGYI-T-4966/02 & OGYI-T4966/03 & OGYI-T-4966/04 & OGYI-T-4966/05 & OGYI-T-4966/06

Austria

Product Name (in authorisation country)

Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin

MRP/DCP Authorisation number

DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005

Neurontin

Neurontin

DE/H/0899/004 & DE/H/0899/005

Neurontin Neurontin Neurontin Neurontin

MAH of product in the member state

Member State where product is authorised

1-22737 & 1-22738

Pfizer Corporation Austria Gesellschaft M.B.H.

Austria

14287 & 14288

Pfizer Oy

Finland

15369 & 15370

Pfizer Ab

Sweden

21/0251/02–S & 21/0252/02-S

Pfizer Limited

Slovakia

21/352/03-C & 21/353/03-C

Pfizer, Spol. S R.O.

Czech Republic

26443/9-4-2009 & 26444/9-4-2009

Pfizer Hellas, A.E.

Greece

2960680 & 2960789 & 5815881 & 5815980

Laboratórios Pfizer, Lda.

Portugal

32601 & 32602 34009 300 535 5 3 & 34009 300 535 6 0 & 34009 347 340 8 3 & 34009 347 342 0 5 & 34009 347 591 0 9 & 34009 347 592 7 7 & 34009 359 001 9 7 & 34009 359 002 5 8 & 34009 359 003 1 9 & 34009 359 004 8 7

Pfizer Aps

Denmark

Pfizer Holding France (S.C.A.)

France

43728.00.00 & 43728.01.00

Pfizer Pharma Gmbh

Germany

63.149 & 63.150

Parke-Davis, S.L.

Spain

99-854 & 99-855

Pfizer As

Norway

990081 (IS) & 990082 (IS)

Pfizer Aps

Iceland

BE369013 & BE369022 H/99/01105/034 & H/99/01105/035 & H/99/01105/036 & H/99/01105/037 & H/99/01105/038 & H/99/01105/039 & H/99/01105/040 & H/99/01105/041 & H/99/01105/042 & H/99/01105/043 & H/99/01105/044 & H/99/01105/045 & H/99/01105/046 & H/99/01105/047 &

Pfizer S.A. (Belgium)

Belgium

Pfizer Luxembourg Sarl

Slovenia

DE/H/0899/005

DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005

Neurontin

National Authorisation Number

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

Pfizer Limited

Lithuania

PA 822/15/4 & PA 822/15/5

Pfizer Healthcare Ireland

Ireland

PL 00057/0538 & PL 00057/0539

Pfizer Limited

United Kingdom

RVG 25247 & RVG 25248

Pfizer B.V.

Netherlands

H/99/01105/048 & H/99/01105/049 & H/99/01105/050 & H/99/01105/051 & H/99/01105/052 & H/99/01105/053 & H/99/01105/054 & H/99/01105/055 & H/99/01105/056 & H/99/01105/057 & H/99/01105/058 & H/99/01105/059 & H/99/01105/060 & H/99/01105/061 & H/99/01105/062 & H/99/01105/063 & H/99/01105/064 & H/99/01105/065 & H/99/01105/066 & H/99/01105/067 & H/99/01105/068 & H/99/01105/069 & H/99/01105/070 & H/99/01105/071 & H/99/01105/072 & H/99/01105/073 LT/1/08/1297/031 & LT/1/08/1297/032 & LT/1/08/1297/033 & LT/1/08/1297/034 & LT/1/08/1297/035 & LT/1/08/1297/036 & LT/1/08/1297/037 & LT/1/08/1297/038 & LT/1/08/1297/039 & LT/1/08/1297/040 & LT/1/08/1297/041 & LT/1/08/1297/042 & LT/1/08/1297/043 & LT/1/08/1297/044 & LT/1/08/1297/045 & LT/1/08/1297/046 & LT/1/08/1297/047 & LT/1/08/1297/048

Neurontin

DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005 DE/H/0899/004 & DE/H/0899/005

Neurontin 100

DE/H/0899/001

7692

Pfizer Europe Ma Eeig

Poland

Neurontin 300

DE/H/0899/002

7693

Pfizer Europe Ma Eeig

Poland

Neurontin 400

DE/H/0899/003

7694

Pfizer Europe Ma Eeig

Poland

Neurontin 600

DE/H/0899/004

10174

Pfizer Polska Sp. Z O.O.

Poland

Neurontin 800

DE/H/0899/005

10175

Pfizer Polska Sp. Z O.O.

Poland

20000710 & 20000711 039037015 & 039037027 & 039037039 039037041 & 039037054 039037066

Pfizer Europe Ma Eeig

Bulgaria

EG S.p.A Rosemont Pharmaceuticals Limited

Italy

Neurontin Neurontin Neurontin

неуронтин Keneil Gabaliquid Geriasan

UK/H/2047/001

82765.00.00

Germany

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

Gabalept

DK/H/0393/001

31458

Hexal Ag

Denmark

Gabapentin 1a Farma

DK/H/0392/001

31455

1a Farma A/S

Denmark

gabapentin - European Medicines Agency - Europa EU

Sep 29, 2016 - Estonia. Neurontin. DE/H/0899/002 &. DE/H/0899/003. 1-20678 & 1-20679. Pfizer Corporation Austria. Gesellschaft M.B.H.. Austria. Neurontin.

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