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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
03 October 2019 EMA/556780/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: gabapentin
Procedure no.: PSUSA/00001499/201902
List of nationally authorised medicinal products EMA/556780/2019 Page 2/42
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
GabaLiquid GeriaSan 50 mg/ml Lösung zum Einnehmen DE/H/4632/001 96498.00.00
INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH DE
Gabapentin Noumed 100mg Capsules not available PL 44041/0019 NOUMED LIFE SCIENCES UK
Gabapentin Noumed 300mg Capsules not available PL 44041/0020 NOUMED LIFE SCIENCES UK
Gabapentin Noumed 400mg Capsules not available PL 44041/0021 NOUMED LIFE SCIENCES UK
List of nationally authorised medicinal products EMA/556780/2019 Page 3/42
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
Neurontin 600 mg Filmtabletten Gabapentin DE/H/0899/004 BE369013 PFIZER S.A. (BELGIUM) BE
Neurontin 800 mg filmdragerade tabletter DE/H/0899/005 14288 PFIZER OY FI
Neurontin 800 mg Filmtabletten Gabapentin DE/H/0899/005 BE369022 PFIZER S.A. (BELGIUM) BE
Neurontin 300 mg Hartkapseln Gabapentin DE/H/0899/002 BE181142 PFIZER S.A. (BELGIUM) BE
Neurontin 100 mg Hartkapseln Gabapentin DE/H/0899/001 BE181151 PFIZER S.A. (BELGIUM) BE
Neurontin 600 mg filmdragerade tabletter gabapentin DE/H/0899/004 14287 PFIZER OY FI
List of nationally authorised medicinal products EMA/556780/2019 Page 4/42
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
Neurontin 300 mg hårda kapslar gabapentin DE/H/0899/002 11662 PFIZER OY FI
Neurontin 400 mg hårda kapslar gabapentin DE/H/0899/003 11663 PFIZER OY FI
Neurontin 400 mg Hartkapseln Gabapentin DE/H/0899/003 BE181133 PFIZER S.A. (BELGIUM) BE
Neurontin 300 mg Hartkapseln Gabapentin DE/H/0899/002 2009030267 PFIZER S.A. (BELGIUM) LU
Neurontin 400 mg Hartkapseln Gabapentin DE/H/0899/003 2009030268 PFIZER S.A. (BELGIUM) LU
Neurontin 100 mg Hartkapseln Gabapentin DE/H/0899/001 2009030266 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/556780/2019 Page 5/42
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
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/072 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/001 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/002 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/026 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/012 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/054 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 6/42
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
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/071 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/025 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/034 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/073 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/003 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/023 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 7/42
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
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/027 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/008 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/004 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/029 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/028 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/006 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 8/42
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
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/010 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/009 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/030 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/005 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/032 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/013 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 9/42
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
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/014 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/031 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/011 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/038 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/036 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/035 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 10/42
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
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/019 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/018 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/017 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/037 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/033 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/016 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 11/42
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
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/015 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/044 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/020 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/059 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/053 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/049 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 12/42
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
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/057 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/062 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/043 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/068 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/047 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/067 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 13/42
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
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/058 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/069 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/022 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/042 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/070 PFIZER LUXEMBOURG SARL SI
Neurontin 300 mg trde kapsule DE/H/0899/002 H/99/01105/021 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 14/42
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
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/040 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/066 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/046 PFIZER LUXEMBOURG SARL SI
Neurontin 400 mg trde kapsule DE/H/0899/003 H/99/01105/024 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/063 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg trde kapsule DE/H/0899/001 H/99/01105/007 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 15/42
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
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/045 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/064 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/061 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/051 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/052 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/041 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 16/42
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
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/065 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/055 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/050 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/056 PFIZER LUXEMBOURG SARL SI
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/039 PFIZER LUXEMBOURG SARL SI
Neurontin 800 mg filmsko obložene tablete DE/H/0899/005 H/99/01105/060 PFIZER LUXEMBOURG SARL SI
List of nationally authorised medicinal products EMA/556780/2019 Page 17/42
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
Neurontin 600 mg filmsko obložene tablete DE/H/0899/004 H/99/01105/048 PFIZER LUXEMBOURG SARL SI
Neurontin 100 mg hard capsules DE/H/0899/001 PL 00057/0853 PFIZER LIMITED UK
Neurontin 300 mg hard capsules DE/H/0899/002 PA 0822/015/002 PFIZER HEALTHCARE IRELAND IE
Neurontin 300 mg hard capsules DE/H/0899/002 PL 00057/0536 PFIZER LIMITED UK
Neurontin 400 mg hard capsules DE/H/0899/003 PL 00057/0537 PFIZER LIMITED UK
Neurontin 400 mg cápsulas DE/H/0899/003 5815782 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/556780/2019 Page 18/42
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
Neurontin 100 mg hard capsules DE/H/0899/001 PA 0822/015/001 PFIZER HEALTHCARE IRELAND IE
Neurontin 400 mg hörð hylki DE/H/0899/003 920270 PFIZER APS IS
Neurontin® 300 mg - Hartkapseln DE/H/0899/002 1-20679
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
NEURONTIN 600 mg, comprimé pelliculé DE/H/0899/004 34009 300 535 5 3 PFIZER HOLDING FRANCE FR
NEURONTIN 800 mg, comprimé pelliculé DE/H/0899/005 34009 300 535 6 0 PFIZER HOLDING FRANCE FR
Neurontin 300 mg hörð hylki DE/H/0899/002 920269 PFIZER APS IS
List of nationally authorised medicinal products EMA/556780/2019 Page 19/42
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
Neurontin 400 mg harde capsules DE/H/0899/003 BE181133 PFIZER S.A. (BELGIUM) BE
Neurontin 400 mg gélules DE/H/0899/003 2009030268 PFIZER S.A. (BELGIUM) LU
Neurontin 400 mg kapselit, kovat DE/H/0899/003 11663 PFIZER OY FI
Neurontin 100 mg hörð hylki DE/H/0899/001 IS/1/01/119/01 PFIZER APS IS
Neurontin® 400 mg - Hartkapseln DE/H/0899/003 1-20678
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
Neurontin 300 mg kapselit, kovat DE/H/0899/002 11662 PFIZER OY FI
List of nationally authorised medicinal products EMA/556780/2019 Page 20/42
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
Neurontin, 300 mg kõvakapsel DE/H/0899/002 212298 PFIZER EUROPE MA EEIG EE
Neurontin 400 mg hårda kapslar DE/H/0899/003 12059 PFIZER AB SE
Neurontin 100 mg capsule rigide DE/H/0899/001 028740013 PFIZER ITALIA S.R.L. IT
Neurontin, hårde kapsler DE/H/0899/002 32061 PFIZER APS DK
Neurontin, hårde kapsler DE/H/0899/003 32062 PFIZER APS DK
Neurontin 400 mg cápsulas duras DE/H/0899/003 60.622 PARKE-DAVIS, S.L. ES
List of nationally authorised medicinal products EMA/556780/2019 Page 21/42
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
Neurontin 100 mg gélules DE/H/0899/001 2009030266 PFIZER S.A. (BELGIUM) LU
Neurontin 300 mg cápsulas duras DE/H/0899/002 60.621 PARKE-DAVIS, S.L. ES
Neurontin 100 mg hårda kapslar DE/H/0899/001 12072 PFIZER AB SE
Neurontin 800 mg comprimés pelliculés DE/H/0899/005 2009030270 PFIZER S.A. (BELGIUM) LU
Neurontin 600 mg comprimés pelliculés DE/H/0899/004 2009030269 PFIZER S.A. (BELGIUM) LU
Neurontin 800 mg Filmtabletten Gabapentin DE/H/0899/005 2009030270 PFIZER S.A. (BELGIUM) LU
List of nationally authorised medicinal products EMA/556780/2019 Page 22/42
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
Neurontin 600 mg Filmtabletten Gabapentin DE/H/0899/004 2009030269 PFIZER S.A. (BELGIUM) LU
Neurontin 300 mg gélules DE/H/0899/002 2009030267 PFIZER S.A. (BELGIUM) LU
Neurontin 300 mg hårda kapslar DE/H/0899/002 12058 PFIZER AB SE
Neurontin 300 mg cápsulas DE/H/0899/002 5815683 LABORATÓRIOS PFIZER, LDA. PT
Neurontin 100 mg cápsulas DE/H/0899/001 2433084 LABORATÓRIOS PFIZER, LDA. PT
Neurontin 300 mg cápsulas DE/H/0899/002 3669587 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/556780/2019 Page 23/42
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
Neurontin 300 mg harde kapsler DE/H/0899/002 8220 PFIZER AS NO
Neurontin 400 mg harde kapsler DE/H/0899/003 8221 PFIZER AS NO
NEURONTIN 300 mg cietās kapsulas DE/H/0899/002 01-0277 PFIZER EUROPE MA EEIG LV
Neurontin 400 mg cápsulas DE/H/0899/003 2433381 LABORATÓRIOS PFIZER, LDA. PT
Neurontin 100 mg harde kapsler DE/H/0899/001 00-2995 PFIZER AS NO
Neurontin 300 mg cápsulas DE/H/0899/002 2433282 LABORATÓRIOS PFIZER, LDA. PT
List of nationally authorised medicinal products EMA/556780/2019 Page 24/42
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
Neurontin 100 mg cápsulas DE/H/0899/001 2433183 LABORATÓRIOS PFIZER, LDA. PT
NEURONTIN 100 mg cietās kapsulas DE/H/0899/001 01-0276 PFIZER EUROPE MA EEIG LV
Neurontin 100 mg cápsulas DE/H/0899/001 5815584 LABORATÓRIOS PFIZER, LDA. PT
Neurontin® 400 mg Hartkapseln DE/H/0899/003 47275.02.00 PFIZER PHARMA PFE GMBH DE
Neurontin® 100 mg Hartkapseln DE/H/0899/001 47275.00.00 PFIZER PHARMA PFE GMBH DE
Neurontin® 300 mg Hartkapseln DE/H/0899/002 47275.01.00 PFIZER PHARMA PFE GMBH DE
List of nationally authorised medicinal products EMA/556780/2019 Page 25/42
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
Neurontin® 600 mg Filmtabletten DE/H/0899/004 43728.00.00 PFIZER PHARMA PFE GMBH DE
Neurontin® 800 mg Filmtabletten DE/H/0899/005 43728.01.00 PFIZER PHARMA PFE GMBH DE
Neurontin 800 mg tabletit, kalvopäällysteiset DE/H/0899/005 14288 PFIZER OY FI
Neurontin 600 mg film-coated tablets DE/H/0899/004 PA 0822/015/004 PFIZER HEALTHCARE IRELAND IE
Neurontin 600 mg film-coated tablets DE/H/0899/004 PL 00057/0538 PFIZER LIMITED UK
Neurontin 600 mg tabletit, kalvopäällysteiset DE/H/0899/004 14287 PFIZER OY FI
List of nationally authorised medicinal products EMA/556780/2019 Page 26/42
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
Neurontin 800 mg film-coated tablets DE/H/0899/005 PL 00057/0539 PFIZER LIMITED UK
Neurontin, filmovertrukne tabletter DE/H/0899/004 32601 PFIZER APS DK
Neurontin 300, harde capsules 300 mg DE/H/0899/002 RVG 22482 PFIZER B.V. NL
Neurontin, filmovertrukne tabletter DE/H/0899/005 32602 PFIZER APS DK
Neurontin 400, harde capsules 400 mg DE/H/0899/003 RVG 22483 PFIZER B.V. NL
Neurontin 100, harde capsules 100 mg DE/H/0899/001 RVG 22481 PFIZER B.V. NL
List of nationally authorised medicinal products EMA/556780/2019 Page 27/42
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
Neurontin 600 mg filmdragerade tabletter DE/H/0899/004 15369 PFIZER AB SE
Neurontin 800 mg filmdragerade tabletter DE/H/0899/005 15370 PFIZER AB SE
Neurontin 600 mg comprimidos recubiertos con película DE/H/0899/004 63.150 PARKE-DAVIS, S.L. ES
Neurontin 600 mg comprimidos revestidos por película DE/H/0899/004 5815881 LABORATÓRIOS PFIZER, LDA. PT
Neurontin 600, filmomhulde tabletten 600 mg DE/H/0899/004 RVG 25247 PFIZER B.V. NL
NEURONTIN 100 mg Tvrdé tobolky DE/H/0899/001 21/461/97-C PFIZER, SPOL. S R.O. CZ
List of nationally authorised medicinal products EMA/556780/2019 Page 28/42
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
NEURONTIN 800 mg potahované tablety DE/H/0899/005 21/353/03-C PFIZER, SPOL. S R.O. CZ
Neurontin 600 mg comprimidos revestidos por película DE/H/0899/004 2960680 LABORATÓRIOS PFIZER, LDA. PT
Neurontin 800 mg comprimidos recubiertos con película DE/H/0899/005 63.149 PARKE-DAVIS, S.L. ES
Neurontin 800, filmomhulde tabletten 800 mg DE/H/0899/005 RVG 25248 PFIZER B.V. NL
Neurontin 800 mg filmomhulde tabletten DE/H/0899/005 BE369022 PFIZER S.A. (BELGIUM) BE
NEURONTIN 600 mg potahované tablety DE/H/0899/004 21/352/03-C PFIZER, SPOL. S R.O. CZ
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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
NEURONTIN 400 mg Tvrdé tobolky DE/H/0899/003 21/463/97-C PFIZER, SPOL. S R.O. CZ
Neurontin 800 mg filmdrasjerte tabletter DE/H/0899/005 99-855 PFIZER AS NO
Neurontin 600 mg filmomhulde tabletten DE/H/0899/004 BE369013 PFIZER S.A. (BELGIUM) BE
NEURONTIN 300 mg Tvrdé tobolky DE/H/0899/002 21/462/97-C PFIZER, SPOL. S R.O. CZ
Neurontin 400 mg hard capsules DE/H/0899/003 PA 0822/015/003 PFIZER HEALTHCARE IRELAND IE
Neurontin® 600 mg - Filmtabletten DE/H/0899/004 1-22737
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
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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
Neurontin® 800 mg - Filmtabletten DE/H/0899/005 1-22738
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. AT
Neurontin 800 mg film-coated tablets DE/H/0899/005 PA 0822/015/005 PFIZER HEALTHCARE IRELAND IE
Neurontin 600 mg filmdrasjerte tabletter DE/H/0899/004 99-854 PFIZER AS NO
NEURONTIN 100 mg, gélule DE/H/0899/001 34009 337 896 3 3 PFIZER HOLDING FRANCE FR
NEURONTIN 400 mg cietās kapsulas DE/H/0899/003 01-0278 PFIZER EUROPE MA EEIG LV
NEURONTIN 800 mg, comprimé pelliculé DE/H/0899/005 34009 347 592 7 7 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/556780/2019 Page 31/42
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
Neurontin 100 mg harde capsules DE/H/0899/001 BE181151 PFIZER S.A. (BELGIUM) BE
Neurontin 300 mg καψάκια σκληρά DE/H/0899/002 17445 PFIZER HELLAS, A.E. CY
Neurontin 300 mg kemény kapszula DE/H/0899/002 OGYI-T-4966/04 PFIZER KFT. HU
Neurontin 300 mg harde capsules DE/H/0899/002 BE181142 PFIZER S.A. (BELGIUM) BE
Neurontin 400 mg kemény kapszula DE/H/0899/003 OGYI-T-4966/06 PFIZER KFT. HU
NEURONTIN 400 mg, gélule DE/H/0899/003 34009 338 014 4 1 PFIZER HOLDING FRANCE FR
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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
NEURONTIN 300 mg, gélule DE/H/0899/002 34009 337 900 0 4 PFIZER HOLDING FRANCE FR
Neurontin 800 mg comprimidos revestidos por película DE/H/0899/005 2960789 LABORATÓRIOS PFIZER, LDA. PT
NEURONTIN 800 mg, comprimé pelliculé DE/H/0899/005 34009 347 342 0 5 PFIZER HOLDING FRANCE FR
Neurontin 400 mg kemény kapszula DE/H/0899/003 OGYI-T-4966/05 PFIZER KFT. HU
NEURONTIN 600 mg, comprimé pelliculé DE/H/0899/004 34009 347 340 8 3 PFIZER HOLDING FRANCE FR
NEURONTIN 600 mg, comprimé pelliculé DE/H/0899/004 34009 359 001 9 7 PFIZER HOLDING FRANCE FR
List of nationally authorised medicinal products EMA/556780/2019 Page 33/42
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
NEURONTIN 600 mg, comprimé pelliculé DE/H/0899/004 34009 347 591 0 9 PFIZER HOLDING FRANCE FR
NEURONTIN 300 mg, gélule DE/H/0899/002 34009 337 901 7 2 PFIZER HOLDING FRANCE FR
NEURONTIN 600 mg, comprimé pelliculé DE/H/0899/004 34009 359 002 5 8 PFIZER HOLDING FRANCE FR
Neurontin 600 mg επικαλυμμένα με λεπτό υμένιο δισκία DE/H/0899/004 26443/9-4-2009 PFIZER HELLAS, A.E. GR
Neurontin 800 mg comprimidos revestidos por película DE/H/0899/005 5815980 LABORATÓRIOS PFIZER, LDA. PT
NEURONTIN 800 mg, comprimé pelliculé DE/H/0899/005 34009 359 003 1 9 PFIZER HOLDING FRANCE FR
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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
NEURONTIN 800 mg, comprimé pelliculé DE/H/0899/005 34009 359 004 8 7 PFIZER HOLDING FRANCE FR
NEURONTIN 400 mg, gélule DE/H/0899/003 34009 337 904 6 2 PFIZER HOLDING FRANCE FR
NEURONTIN 800 mg apvalkotās tabletes DE/H/0899/005 03-0017 PFIZER EUROPE MA EEIG LV
Neurontin 400 mg καψάκια σκληρά DE/H/0899/003 17446 PFIZER HELLAS, A.E. CY
Neurontin 400 mg καψάκια σκληρά DE/H/0899/003 26442/9-4-2009 PFIZER HELLAS, A.E. GR
Neurontin 800 mg filmuhúðaðar töflur DE/H/0899/005 990082 PFIZER APS IS
List of nationally authorised medicinal products EMA/556780/2019 Page 35/42
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
Neurontin 300 mg kemény kapszula DE/H/0899/002 OGYI-T-4966/03 PFIZER KFT. HU
Neurontin 300 mg καψάκια σκληρά DE/H/0899/002 26441/9-4-2009 PFIZER HELLAS, A.E. GR
NEURONTIN 600 mg apvalkotās tabletes DE/H/0899/004 03-0016 PFIZER EUROPE MA EEIG LV
Neurontin 100 mg kemény kapszula DE/H/0899/001 OGYI-T-4966/01 PFIZER KFT. HU
Neurontin 100 mg kemény kapszula DE/H/0899/001 OGYI-T-4966/02 PFIZER KFT. HU
Neurontin 600 mg filmuhúðaðar töflur DE/H/0899/004 990081 PFIZER APS IS
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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
Neurontin 400 mg capsule rigide DE/H/0899/003 028740037 PFIZER ITALIA S.R.L. IT
Neurontin 300 mg capsule rigide DE/H/0899/002 028740025 PFIZER ITALIA S.R.L. IT
NEURONTIN 100 mg, gélule DE/H/0899/001 34009 337 898 6 2 PFIZER HOLDING FRANCE FR
NEURONTIN 300, 300 mg, kapsułki twarde DE/H/0899/002 7693 PFIZER EUROPE MA EEIG PL
NEURONTIN 600, 600 mg, tabletki powlekane DE/H/0899/004 10174 PFIZER POLSKA SP. Z O.O. PL
NEURONTIN 400, 400 mg, kapsułki twarde DE/H/0899/003 7694 PFIZER EUROPE MA EEIG PL
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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
NEURONTIN 800, 800 mg, tabletki powlekane DE/H/0899/005 10175 PFIZER POLSKA SP. Z O.O. PL
NEURONTIN 100, 100 mg, kapsułki twarde DE/H/0899/001 7692 PFIZER EUROPE MA EEIG PL
Neurontin 600 mg comprimés pelliculés DE/H/0899/004 BE369013 PFIZER S.A. (BELGIUM) BE
Neurontin 800 mg comprimés pelliculés DE/H/0899/005 BE369022 PFIZER S.A. (BELGIUM) BE
Neurontin 100 mg gélules DE/H/0899/001 BE181151 PFIZER S.A. (BELGIUM) BE
Neurontin 300 mg gélules DE/H/0899/002 BE181142 PFIZER S.A. (BELGIUM) BE
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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
Neurontin 400 mg gélules DE/H/0899/003 BE181133 PFIZER S.A. (BELGIUM) BE
Neurontin 400 mg kapsule not available HR-H-227912224 PFIZER CROATIA D.O.O. HR
Neurontin 300 mg kapsule not available HR-H-198579675 PFIZER CROATIA D.O.O. HR
Gabapentin Colonis 50mg/ml Oral Solution UK/H/6181/001 PL 41344/0028 COLONIS PHARMA LIMITED UK
Неуронтин 400 mg твърди капсули not available 20000711 PFIZER EUROPE MA EEIG BG
Неуронтин 300 mg твърди капсули not available 20000710 PFIZER EUROPE MA EEIG BG
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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
Gabapentin "1A Farma", hårde kapsler DK/H/0392/001 31455 1A FARMA A/S DK
Gabapentin Medreich 100mg Capsules not available PL 21880/0075 MEDREICH PLC UK
KENEIL 600 mg compresse rivestite con film not available 039037015 EG S.P.A. IT
KENEIL 600 mg compresse rivestite con film not available 039037039 EG S.P.A. IT
List of nationally authorised medicinal products EMA/556780/2019 Page 40/42
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
KENEIL 600 mg compresse rivestite con film not available 039037027 EG S.P.A. IT
KENEIL 800 mg compresse rivestite con film not available 039037041 EG S.P.A. IT
KENEIL 800 mg compresse rivestite con film not available 039037066 EG S.P.A. IT
KENEIL 800 mg compresse rivestite con film not available 039037054 EG S.P.A. IT
Gabaratio, hårde kapsler DK/H/0398/001 33804 RATIOPHARM GMBH DK
List of nationally authorised medicinal products EMA/556780/2019 Page 41/42
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
Gabapentin Rosemont 50mg/ml Oral Solution UK/H/2047/001 PA 0312/025/001
ROSEMONT PHARMACEUTICALS LIMITED IE
Gabapentin Medreich 300mg Capsules not available PL 21880/0076 MEDREICH PLC UK
GABAPENTINE TEVA 800 mg, comprimé pelliculé not available NL32812 TEVA SANTÉ FR
Gabapentin Teva 50 mg/ml oral solution. UK/H/6641/001 PL 00289/2154 TEVA UK LIMITED UK
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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
Gabapentin ”Aurobindo”, hårde kapsler PT/H/1945/001 41673 AUROBINDO PHARMA (MALTA) LIMITED DK
Gabapentin Medreich 400mg Capsules not available PL 21880/0077 MEDREICH PLC UK
