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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
25 July 2018
EMA/600046/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: lamotrigine
Procedure no.: PSUSA/00001825/201711
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 2/44
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
Seizal 25 mg Τablets not available 22069 DELORBIS
PHARMACEUTICALS LTD
CY
Seizal 50 mg Τablets not available 22070 DELORBIS
PHARMACEUTICALS LTD
CY
Seizal 100 mg Τablets not available 22071 DELORBIS
PHARMACEUTICALS LTD
CY
Seizal 200 mg Τablets not available 22072 DELORBIS
PHARMACEUTICALS LTD
CY
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/057 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/058 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/059 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/060 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/061 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/062 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/063 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg tablete NL/H/1540/001 H/96/00871/064 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/065 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/066 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 3/44
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
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/067 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/068 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/069 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/070 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/071 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg tablete NL/H/1540/002 H/96/00871/072 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/073 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/074 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/075 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/076 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/077 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/078 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/079 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/080 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 4/44
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
Lamictal 100 mg tablete NL/H/1540/003 H/96/00871/081 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg tablete NL/H/1540/004 H/96/00871/082 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg tablete NL/H/1540/004 H/96/00871/083 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg tablete NL/H/1540/004 H/96/00871/084 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg tablete NL/H/1540/004 H/96/00871/085 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg tablete NL/H/1540/004 H/96/00871/086 GLAXOSMITHKLINE D.O.O. SI
Lamictal δισκία 25 mg NL/H/1540/001 2018101 GLAXOSMITHKLINE AEBE GR
Lamictal δισκία 100 mg NL/H/1540/003 2018103 GLAXOSMITHKLINE AEBE GR
Lamictal δισκία 200 mg NL/H/1540/004 2018107 GLAXOSMITHKLINE AEBE GR
Lamictal δισκία 50 mg NL/H/1540/002 2018102 GLAXOSMITHKLINE AEBE GR
Lamictal 25 mg tablets. NL/H/1540/001 PL 00003/0272 THE WELLCOME
FOUNDATION LTD
UK
Ламиктал 25 mg таблетки NL/H/1540/001 2001 1209 GLAXOSMITHKLINE EOOD BG
Lamictal, tabletter NL/H/1540/001 13902 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 25 mg tablets NL/H/1540/001 PA1077/061/001 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 5/44
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
Lamictal 25 mg tablets. NL/H/1540/001 MA 192/00503 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal 25 mg tabletten NL/H/1540/001 RVG 103363 GLAXOSMITHKLINE B.V. NL
Lamitrin, 25 mg, tabletki NL/H/1540/001 R/3548 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 25 mg comprimidos NL/H/1540/001 5291695 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 25 mg comprimidos NL/H/1540/001 5291794 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 25 mg comprimidos NL/H/1540/001 2252781 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 25 mg comprimidos NL/H/1540/001 2252880 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 25 mg tablety NL/H/1540/001 21/0802/92-C/S GLAXOSMITHKLINE
SLOVAKIA S.R.O.
SK
Lamictal 25 mg tabletter. NL/H/1540/001 12008 GLAXOSMITHKLINE AB SE
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/01 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/02 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/03 THE WELLCOME
FOUNDATION LTD
RO
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 6/44
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
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/04 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/05 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/06 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/07 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/08 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/09 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg comprimate NL/H/1540/001 1742/2009/10 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 25 mg tabletta NL/H/1540/001 OGYI-T-4094/04 GLAXOSMITHKLINE KFT. HU
Lamictal 25 mg tabletta NL/H/1540/001 OGYI-T-4094/08 GLAXOSMITHKLINE KFT. HU
Lamictal 100 mg tablets NL/H/1540/003 PL 00003/0274 THE WELLCOME
FOUNDATION LTD
UK
Ламиктал 100 mg таблетки NL/H/1540/003 2001 1211 GLAXOSMITHKLINE EOOD BG
Lamictal 100 mg, tablety NL/H/1540/003 21/802/92-C/C THE WELLCOME
FOUNDATION LTD
CZ
Lamictal, tabletter NL/H/1540/003 13904 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 100 mg tabletta NL/H/1540/003 OGYI-T-4094/10 GLAXOSMITHKLINE KFT. HU
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 7/44
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
Lamictal 100 mg tabletta NL/H/1540/003 OGYI-T-4094/15 GLAXOSMITHKLINE KFT. HU
Lamictal 100 mg tablets NL/H/1540/003 PA1077/061/003 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 100 mg tablets NL/H/1540/003 MA 192/00505 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal 100 mg tabletten NL/H/1540/003 RVG 103366 GLAXOSMITHKLINE B.V. NL
Lamitrin, 100 mg, tabletki NL/H/1540/003 R/3463 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 100 mg comprimidos NL/H/1540/003 2253185 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/01 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/02 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/03 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/04 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/05 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/06 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/07 THE WELLCOME
FOUNDATION LTD
RO
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 8/44
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
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/08 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg comprimate NL/H/1540/003 1744/2009/09 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 100 mg tabletter NL/H/1540/003 12010 GLAXOSMITHKLINE AB SE
Lamictal 200 mg tablets NL/H/1540/004 PL 00003/0297 THE WELLCOME
FOUNDATION LTD
UK
Lamictal, tabletter NL/H/1540/004 14790 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 200 mg tablets NL/H/1540/004 PA1077/061/004 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 200 mg tabletten NL/H/1540/004 RVG 103367 GLAXOSMITHKLINE B.V. NL
Lamictal 200 mg comprimidos NL/H/1540/004 2521581 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 200 mg tabletter NL/H/1540/004 12011 GLAXOSMITHKLINE AB SE
Lamictal 50 mg tablets. NL/H/1540/002 PL 00003/0273 THE WELLCOME
FOUNDATION LTD
UK
Ламиктал 50 mg таблетки NL/H/1540/002 2001 1210 GLAXOSMITHKLINE EOOD BG
Lamictal 50 mg, tablety NL/H/1540/002 21/802/92-B/C THE WELLCOME
FOUNDATION LTD
CZ
Lamictal, tabletter NL/H/1540/002 13903 GLAXOSMITHKLINE PHARMA
A/S
DK
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 9/44
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
Lamictal 50 mg tabletta NL/H/1540/002 OGYI-T-4094/06 GLAXOSMITHKLINE KFT. HU
Lamictal 50 mg tabletta NL/H/1540/002 OGYI-T-4094/09 GLAXOSMITHKLINE KFT. HU
Lamictal 50 mg tablets NL/H/1540/002 PA1077/061/002 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 50 mg tablets. NL/H/1540/002 MA 192/00504 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal 50 mg tabletten NL/H/1540/002 RVG 103364 GLAXOSMITHKLINE B.V. NL
Lamitrin, 50 mg, tabletki NL/H/1540/002 R/3462 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 50 mg comprimidos NL/H/1540/002 2252989 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 50 mg comprimidos NL/H/1540/002 2253086 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 50 mg comprimidos NL/H/1540/002 5291885 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/01 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/02 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/03 THE WELLCOME
FOUNDATION LTD
RO
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 10/44
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
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/04 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/05 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/06 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/07 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/08 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg comprimate NL/H/1540/002 1743/2009/09 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 50 mg tablety NL/H/1540/002 21/0404/09-S GLAXOSMITHKLINE
SLOVAKIA S.R.O.
SK
Lamictal 50 mg tabletter. NL/H/1540/002 12009 GLAXOSMITHKLINE AB SE
Lamictal 5 mg,
žvýkací/dispergovatelné
tablety
NL/H/1539/002 21/483/96-A/C THE WELLCOME
FOUNDATION LTD
CZ
LAMOTRIX 200 mg tablety SE/H/0728/004 21/662/07-C MEDOCHEMIE LTD. CZ
MEDOTRIGIN 200 mg tablety SE/H/0728/004 21/0413/07-S MEDOCHEMIE LTD. SK
Lamotrigine Aurobindo 50 mg
dispersible tablets
NL/H/2260/003 MA807/03301 AUROBINDO PHARMA
(MALTA) LIMITED
MT
Lamotrigine Aurobindo 100
mg dispersible tablets
NL/H/2260/004 MA807/03302 AUROBINDO PHARMA
(MALTA) LIMITED
MT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 11/44
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
Lamotrigine Aurobindo 200
mg dispersible tablets
NL/H/2260/005 MA807/03303 AUROBINDO PHARMA
(MALTA) LIMITED
MT
Lamictal 2 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/001 135577 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Ламиктал 2 mg таблетки за
дъвчене/диспергиращи се
таблетки
NL/H/1539/001 20140091 GLAXOSMITHKLINE EOOD BG
Lamictal 5 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/002 16176 GLAXO GROUP LIMITED CY
Lamictal 2 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/001 22006 GLAXO GROUP LIMITED CY
Lamictal 2 mg tablete za
žvakanje/tablete za oralnu
suspenziju
NL/H/1539/001 UP/I-530-09/13-01/70 GLAXOSMITHKLINE D.O.O. HR
Lamictal 25 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/003 2521888 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 5 mg tuggtabletter /
dispergerbara tabletter
NL/H/1539/002 12320 GLAXOSMITHKLINE OY FI
Lamictal 2 mg dispergerbara
tabletter / tuggtabletter
NL/H/1539/001 23162 GLAXOSMITHKLINE OY FI
Lamictal 25 mg dispergerbara
tabletter / tuggtabletter
NL/H/1539/003 12321 GLAXOSMITHKLINE OY FI
Lamictal 50 mg dispergerbara
tabletter / tuggtabletter
NL/H/1539/004 12322 GLAXOSMITHKLINE OY FI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 12/44
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
Lamictal 100 mg
dispergerbara tabletter /
tuggtabletter
NL/H/1539/005 12323 GLAXOSMITHKLINE OY FI
Lamictal 200 mg
dispergerbara tabletter /
tuggtabletter
NL/H/1539/006 12324 GLAXOSMITHKLINE OY FI
Lamictal 5 mg kauw-
/dispergeerbare tabletten
NL/H/1539/002 BE 185211 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 5 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/002 BE 185211 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 25 mg kauw-
/dispergeerbare tabletten
NL/H/1539/003 BE 185227 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/003 BE185227 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 50 mg kauw-
/dispergeerbare tabletten
NL/H/1539/004 BE 185236 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 50 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/004 BE185236 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 100 mg kauw-
/dispergeerbare tabletten
NL/H/1539/005 BE 185245 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 13/44
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
Lamictal 100 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/005 BE185245 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 200 mg kauw-
/dispergeerbare tabletten
NL/H/1539/006 BE 185254 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 200 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/006 BE185254 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 2 mg kauw-
/dispergeerbare tabletten
NL/H/1539/001 BE 228611 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 2 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/001 BE 228611 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 2 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/001 0260/09/10/0605 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 5 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/002 0260/09/10/0606 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 100 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/005 0260/09/10/0609 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 14/44
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
Lamictal 200 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/006 0260/09/10/0610 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/003 0260/09/10/0607 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 50 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/004 260/09/10/0608 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 2 mg compresse
masticabili/dispersibili
NL/H/1539/001 027807179 GLAXOSMITHKLINE S.P.A. IT
Lamictal 2 mg
žvecljive/disperzibilne tablete
NL/H/1539/001 H/96/00871/001 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/002 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/003 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvecljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/004 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/005 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/006 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/007 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 15/44
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
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/008 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/009 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/010 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/011 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/012 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/013 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/014 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/015 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/016 GLAXOSMITHKLINE D.O.O. SI
Lamictal 25 mg
žvečljive/disperzibilne tablete
NL/H/1539/003 H/96/00871/017 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/018 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/019 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/020 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/021 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 16/44
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
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/022 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/023 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/024 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/025 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/026 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/027 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/028 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/029 GLAXOSMITHKLINE D.O.O. SI
Lamictal 50 mg
žvečljive/disperzibilne tablete
NL/H/1539/004 H/96/00871/030 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvecljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/031 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/032 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/033 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/034 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/035 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 17/44
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
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/036 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/037 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/038 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/039 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/040 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/041 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/042 GLAXOSMITHKLINE D.O.O. SI
Lamictal 100 mg
žvečljive/disperzibilne tablete
NL/H/1539/005 H/96/00871/043 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/044 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/045 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/046 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/047 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/048 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/049 GLAXOSMITHKLINE D.O.O. SI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 18/44
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
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/050 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/051 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/052 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/053 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/054 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/055 GLAXOSMITHKLINE D.O.O. SI
Lamictal 200 mg
žvečljive/disperzibilne tablete
NL/H/1539/006 H/96/00871/056 GLAXOSMITHKLINE D.O.O. SI
Lamictal
μασώμενα/διασπειρόμενα
δισκία 5 mg
NL/H/1539/002 2018104 GLAXOSMITHKLINE AEBE GR
Lamictal
μασώμενα/διασπειρόμενα
δισκία 2 mg
NL/H/1539/001 2018110 GLAXOSMITHKLINE AEBE GR
Lamictal 2 mg
chewable/dispersible tablets
NL/H/1539/001 PL 00003/0375 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 2 mg comprimés à
croquer/dispersibles
NL/H/1539/001 BE 228611 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 2 mg,
žvýkací/dispergovatelné
tablety
NL/H/1539/001 21/330/01-C THE WELLCOME
FOUNDATION LTD
CZ
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 19/44
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
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/001 31464 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal, 2 mg
närimis/dispergeeruvad
tabletid
NL/H/1539/001 332800 GLAXO WELLCOME UK
LIMITED
EE
Lamictal 2 mg purutabletti /
dispergoituva tabletti
NL/H/1539/001 23162 GLAXOSMITHKLINE OY FI
LAMICTAL 2 mg, comprimé
dispersible ou à croquer
NL/H/1539/001 NL25689 LABORATOIRE
GLAXOSMITHKLINE
FR
Lamictal® 2 mg Kautabletten
bzw. Tabletten zur Herstellung
einer Suspension zum
Einnehmen
NL/H/1539/001 49825.00.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 2 mg tuggu-
/dreifitöflur
NL/H/1539/001 IS/1/08/112/01 GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 2 mg
chewable/dispersible tablets
NL/H/1539/001 PA1077/061/005 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 2 mg košļājamās/
disperģējamās tabletes
NL/H/1539/001 02-0401 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 2 mg comprimés à
croquer/dispersibles
NL/H/1539/001 0260/09/10/0605 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 2 mg
chewable/dispersible tablets
NL/H/1539/001 MA 192/00506 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal Dispers 2 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/001 RVG 25344 GLAXOSMITHKLINE B.V. NL
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 20/44
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
Lamictal 2 mg
tyggetabletter/dispergerbare
tabletter
NL/H/1539/001 00-2581 GLAXOSMITHKLINE AS NO
Lamitrin S, 2 mg, tabletki do
rozgryzania i zucia / do
sporzadzania zawiesiny
NL/H/1539/001 9643 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 2 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/001 3338183 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 2 mg comprimate
masticabile/dispersabile
NL/H/1539/001 1745/2009/01 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 2 mg
žuvacie/dispergovatelné
tablety
NL/H/1539/001 21/0150/08-S GLAXOSMITHKLINE
SLOVAKIA S.R.O.
SK
Lamictal 2 mg comprimidos
masticables/dispersables
NL/H/1539/001 64.391 GLAXOSMITHKLINE S.A. ES
Lamictal 2 mg
tuggtabletter/dispergerbara
tabletter
NL/H/1539/001 16321 GLAXOSMITHKLINE AB SE
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/013 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg comprimés à
croquer/dispersibles.
NL/H/1539/002 2009 10 0606 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal Dispers 5 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/002 RVG 19115 GLAXOSMITHKLINE BV NL
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 21/44
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
Lamitrin S, 5 mg, tabletki do
rozgryzania i żucia / do
sporządzania zawiesiny
NL/H/1539/002 7871 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 5 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/002 2521680 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 5 mg
žuvacie/dispergovateľné
tablety
NL/H/1539/002 21/0208/98-S GLAXOSMITHKLINE
SLOVAKIA S.R.O.
SK
Lamictal 5 mg comprimidos
masticables/dispersables
NL/H/1539/002 61.561 GLAXOSMITHKLINE S.A. ES
Lamictal 25 mg
chewable/dispersible tablets
NL/H/1539/003 PL 00003/0347 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 25 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/003 1-20875 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 25 mg comprimés à
croquer/dispersibles
NL/H/1539/003 BE 185227 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 25 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/003 16177 GLAXO GROUP LIMITED CY
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/003 15831 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 25 mg,
närimis/dispergeeruvad
tabletid
NL/H/1539/003 425403 GLAXO WELLCOME UK
LIMITED
EE
Lamictal 25 mg purutabletti /
dispergoituva tabletti
NL/H/1539/003 12321 GLAXOSMITHKLINE OY FI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 22/44
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
LAMICTAL 25 mg, comprimé
dispersible ou à croquer
NL/H/1539/003 NL20297 LABORATOIRE
GLAXOSMITHKLINE
FR
Lamictal® 25 mg
Kautabletten bzw. Tabletten
zur Herstellung einer
Suspension zum Einnehmen
NL/H/1539/003 33122.01.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 25 mg tuggu-
/dreifitöflur
NL/H/1539/003 940290 GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 25 mg
chewable/dispersible tablets
NL/H/1539/003 PA1077/061/007 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 25 mg compresse
masticabili/dispersibili
NL/H/1539/003 027807054 GLAXOSMITHKLINE S.P.A. IT
Lamictal 25 mg compresse
masticabili/dispersibili
NL/H/1539/003 027807130 GLAXOSMITHKLINE S.P.A. IT
Lamictal 25 mg compresse
masticabili/dispersibili
NL/H/1539/003 027807142 GLAXOSMITHKLINE S.P.A. IT
Lamictal 25 mg košļājamās/
disperģējamās tabletes
NL/H/1539/003 97-0588 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/003 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/004 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/005 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/014 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/015 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 23/44
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
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/016 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/017 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/018 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/019 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/057 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/003 LT/1/97/1271/058 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 25 mg comprimés à
croquer/dispersibles
NL/H/1539/003 0260/09/10/0607 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal 25 mg
chewable/dispersible tablets
NL/H/1539/003 MA 192/00502 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal Dispers 25 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/003 RVG 19116 GLAXOSMITHKLINE B.V. NL
Lamictal 25 mg
tyggetabletter/dispergerbare
tabletter.
NL/H/1539/003 8199 GLAXOSMITHKLINE AS NO
Lamitrin S, 25 mg, tabletki do
rozgryzania i żucia / do
sporządzania zawiesiny
NL/H/1539/003 7872 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 25 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/003 5291984 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 24/44
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
Lamictal 25 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/003 5292081 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 25 mg comprimidos
masticables/dispersables
NL/H/1539/003 61.569 GLAXOSMITHKLINE S.A. ES
Lamictal 25 mg
tuggtabletter/dispergerbara
tabletter.
NL/H/1539/003 12791 GLAXOSMITHKLINE AB SE
Lamictal 5 mg
chewable/dispersible tablets.
NL/H/1539/002 PL 00003/0346 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 5 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/002 1-20888 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 5 mg comprimés à
croquer/dispersibles
NL/H/1539/002 BE 185211 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Ламиктал 5 mg таблетки за
дъвчене/диспергиращи се
таблетки
NL/H/1539/002 970 0508 GLAXO GROUP LIMITED BG
Lamictal 5 mg,
žvýkací/dispergovatelné
tablety
NL/H/1539/002 21/483/96-A/C THE WELLCOME
FOUNDATION LTD
CZ
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/002 15830 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 5 mg,
närimis/dispergeeruvad
tabletid
NL/H/1539/002 425703 GLAXO WELLCOME UK
LIMITED
EE
Lamictal 5 mg purutabletti /
dispergoituva tabletti
NL/H/1539/002 12320 GLAXOSMITHKLINE OY FI
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 25/44
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
LAMICTAL 5 mg, comprimé
dispersible ou à croquer
NL/H/1539/002 NL20296 LABORATOIRE
GLAXOSMITHKLINE
FR
Lamictal® 5 mg Kautabletten
bzw. Tabletten zur Herstellung
einer Suspension zum
Einnehmen
NL/H/1539/002 33122.00.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 5 mg
rágótabletta/diszpergálódó
tabletta
NL/H/1539/002 OGYI-T-4094/16 GLAXOSMITHKLINE KFT. HU
Lamictal 5 mg tuggu-
/dreifitöflur
NL/H/1539/002 940289 (IS) GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 5 mg
chewable/dispersible tablets
NL/H/1539/002 PA1077/061/006 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807066 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg košļājamās/
disperģējamās tabletes
NL/H/1539/002 97-0587 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/002 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/043 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/011 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/010 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/009 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 26/44
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
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/012 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg
chewable/dispersible tablets.
NL/H/1539/002 MA 192/00501 GLAXOSMITHKLINE
(IRELAND) LIMITED
MT
Lamictal 5 mg
tyggetabletter/dispergerbare
tabletter
NL/H/1539/002 8198 GLAXOSMITHKLINE AS NO
Lamictal 5 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/002 2521789 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/01 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/02 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/03 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/04 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/05 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/06 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/07 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg
tuggtabletter/dispergerbara
tabletter
NL/H/1539/002 12790 GLAXOSMITHKLINE AB SE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 27/44
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
Lamictal 50 mg
chewable/dispersible tablets
NL/H/1539/004 PL 00003/0368 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 50 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/004 1-20215 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 50 mg comprimés à
croquer/dispersibles
NL/H/1539/004 BE 185236 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 50 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/004 18618 GLAXO GROUP LIMITED CY
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/004 17951 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 50 mg,
närimis/dispergeeruvad
tabletid
NL/H/1539/004 425903 GLAXO WELLCOME UK
LIMITED
EE
Lamictal 50 mg purutabletti /
dispergoituva tabletti
NL/H/1539/004 12322 GLAXOSMITHKLINE OY FI
LAMICTAL 50 mg, comprimé
dispersible ou à croquer
NL/H/1539/004 NL21696 LABORATOIRE
GLAXOSMITHKLINE
FR
Lamictal® 50 mg
Kautabletten bzw. Tabletten
zur Herstellung einer
Suspension zum Einnehmen
NL/H/1539/004 33122.02.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 50 mg tuggu-
/dreifitöflur.
NL/H/1539/004 960234 (IS) GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 50 mg
chewable/dispersible tablets
NL/H/1539/004 PA1077/061/008 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 28/44
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
Lamictal 50 mg compresse
masticabili/dispersibili
NL/H/1539/004 027807080 GLAXOSMITHKLINE S.P.A. IT
Lamictal 50 mg compresse
masticabili/dispersibili
NL/H/1539/004 027807155 GLAXOSMITHKLINE S.P.A. IT
Lamictal 50 mg košļājamās/
disperģējamās tabletes
NL/H/1539/004 97-0589 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/006 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/020 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/021 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/022 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/023 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/024 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/025 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/026 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/027 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/028 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/044 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 29/44
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
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/045 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/046 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/004 LT/1/97/1271/059 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 50 mg comprimés à
croquer/dispersibles
NL/H/1539/004 260/09/10/0608 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal Dispers 50 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/004 RVG 20926 GLAXOSMITHKLINE B.V. NL
Lamictal 50 mg
tyggetabletter/dispergerbare
tabletter.
NL/H/1539/004 96-1876 GLAXOSMITHKLINE AS NO
Lamitrin S, 50 mg, tabletki do
rozgryzania i żucia / do
sporządzania zawiesiny
NL/H/1539/004 12341 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 50 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/004 4014585 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 50 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/004 5292180 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 50 mg comprimidos
masticables/dispersables
NL/H/1539/004 61.562 GLAXOSMITHKLINE S.A. ES
Lamictal 50 mg
tuggtabletter/dispergerbara
tabletter.
NL/H/1539/004 13028 GLAXOSMITHKLINE AB SE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 30/44
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
Lamictal 100 mg
chewable/dispersible tablets
NL/H/1539/005 PL 00003/0348 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 100 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/005 1-20886 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 100 mg comprimés à
croquer/dispersibles
NL/H/1539/005 BE 185245 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 100 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/005 16178 GLAXO GROUP LIMITED CY
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/005 15832 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 100 mg,
närimis/dispergeeruvad
tabletid
NL/H/1539/005 426003 GLAXO WELLCOME UK
LIMITED
EE
Lamictal 100 mg purutabletti /
dispergoituva tabletti
NL/H/1539/005 12323 GLAXOSMITHKLINE OY FI
LAMICTAL 100 mg, comprimé
dispersible ou à croquer
NL/H/1539/005 NL20298 LABORATOIRE
GLAXOSMITHKLINE
FR
Lamictal® 100 mg
Kautabletten bzw. Tabletten
zur Herstellung einer
Suspension zum Einnehmen
NL/H/1539/005 33122.03.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 100 mg tuggu-
/dreifitöflur
NL/H/1539/005 940291 GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 100 mg
chewable/dispersible tablets
NL/H/1539/005 PA1077/061/009 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 31/44
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
Lamictal 100 mg compresse
masticabili/dispersibili
NL/H/1539/005 027807078 GLAXOSMITHKLINE S.P.A. IT
Lamictal 100 mg košļājamās/
disperģējamās tabletes
NL/H/1539/005 97-0590 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletes
NL/H/1539/005 LT/1/97/1271/007 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletes
NL/H/1539/005 LT/1/97/1271/029 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/030 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/031 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/032 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/033 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/034 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/035 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 32/44
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
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/047 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/048 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/049 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/050 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/005 LT/1/97/1271/051 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 100 mg comprimés à
croquer/dispersibles
NL/H/1539/005 0260/09/10/0609 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal Dispers 100 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/005 RVG 19117 GLAXOSMITHKLINE B.V. NL
Lamictal 100 mg
tyggetabletter/dispergerbare
tabletter.
NL/H/1539/005 8200 GLAXOSMITHKLINE AS NO
Lamitrin S, 100 mg, tabletki
do rozgryzania i zucia / do
sporzadzania zawiesiny
NL/H/1539/005 7873 GLAXOSMITHKLINE EXPORT
LTD
PL
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 33/44
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
Lamictal 100 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/005 2521987 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 100 mg
žuvacie/dispergovateľné
tablety
NL/H/1539/005 21/0405/09-S GLAXOSMITHKLINE
SLOVAKIA S.R.O.
SK
Lamictal 100 mg comprimidos
masticables/dispersables
NL/H/1539/005 61.568 GLAXOSMITHKLINE S.A. ES
Lamictal 100 mg
tuggtabletter/dispergerbara
tabletter
NL/H/1539/005 12792 GLAXOSMITHKLINE AB SE
Lamictal 200 mg
chewable/dispersible tablets
NL/H/1539/006 PL 00003/0369 THE WELLCOME
FOUNDATION LTD
UK
Lamictal 200 mg Tabletten
(kaubar/suspendierbar)
NL/H/1539/006 1-20216 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 200 mg comprimés à
croquer/dispersibles
NL/H/1539/006 BE 185254 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 200 mg
μασώμενα/διασπειρόμενα
δισκία
NL/H/1539/006 18617 GLAXO GROUP LIMITED CY
Lamictal,
tyggetabletter/dispergible
tabletter
NL/H/1539/006 17952 GLAXOSMITHKLINE PHARMA
A/S
DK
Lamictal 200 mg purutabletti /
dispergoituva tabletti
NL/H/1539/006 12324 GLAXOSMITHKLINE OY FI
LAMICTAL 200 mg, comprimé
dispersible ou à croquer
NL/H/1539/006 NL21697 LABORATOIRE
GLAXOSMITHKLINE
FR
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 34/44
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
Lamictal® 200 mg
Kautabletten bzw. Tabletten
zur Herstellung einer
Suspension zum Einnehmen
NL/H/1539/006 33122.04.00 GLAXOSMITHKLINE GMBH &
CO. KG
DE
Lamictal 200 mg
rágótabletta/diszpergálódó
tabletta
NL/H/1539/006 OGYI-T-4094/17 GLAXOSMITHKLINE KFT. HU
Lamictal 200 mg tuggu-
/dreifitöflur
NL/H/1539/006 960235 (IS) GLAXOSMITHKLINE PHARMA
A/S
IS
Lamictal 200 mg
chewable/dispersible tablets
NL/H/1539/006 PA1077/061/010 GLAXOSMITHKLINE
(IRELAND) LIMITED
IE
Lamictal 200 mg compresse
masticabili/dispersibili
NL/H/1539/006 027807092 GLAXOSMITHKLINE S.P.A. IT
Lamictal 200 mg košļājamās/
disperģējamās tabletes
NL/H/1539/006 97-0591 GLAXOSMITHKLINE LATVIA
SIA
LV
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/008 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/036 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/037 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/038 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 35/44
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
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/039 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/040 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/041 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/042 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/052 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/053 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/054 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/055 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 200 mg
kramtomosios ar
disperguojamosios tabletės
NL/H/1539/006 LT/1/97/1271/056 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 36/44
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
Lamictal 200 mg comprimés à
croquer/dispersibles
NL/H/1539/006 0260/09/10/0610 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamictal Dispers 200 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/1539/006 RVG 20927 GLAXOSMITHKLINE B.V. NL
Lamictal 200 mg
tyggetabletter/dispergerbare
tabletter
NL/H/1539/006 96-1877 GLAXOSMITHKLINE AS NO
Lamitrin S, 200 mg, tabletki
do rozgryzania i żucia / do
sporządzania zawiesiny
NL/H/1539/006 12342 GLAXOSMITHKLINE EXPORT
LTD
PL
Lamictal 200 mg comprimidos
dispersíveis ou para mastigar
NL/H/1539/006 4014684 GLAXOSMITHKLINE -
PRODUTOS
FARMACEUTICOS, LDA
PT
Lamictal 200 mg comprimidos
masticables/dispersables
NL/H/1539/006 61.563 GLAXOSMITHKLINE S.A. ES
Lamictal 200 mg
tuggtabletter/dispergerbara
tabletter
NL/H/1539/006 13029 GLAXOSMITHKLINE AB SE
Lamictal 5 mg comprimés à
croquer/dispersibles
NL/H/1539/002 BE477093 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 5 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/1539/002 BE477093 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lamictal 5 mg kauw-
/dispergeerbare tabletten
NL/H/1539/002 BE477093 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 37/44
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
Lamictal 2 mg
rágótabletta/diszpergálódó
tabletta
NL/H/1539/001 OGYI-T-4094/18 GLAXOSMITHKLINE KFT. HU
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/087 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/088 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/089 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/090 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/091 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg
žvečljive/disperzibilne tablete
NL/H/1539/002 H/96/00871/092 GLAXOSMITHKLINE D.O.O. SI
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/061 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/063 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/066 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/062 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/064 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg kramtomosios
ar disperguojamosios tabletės
NL/H/1539/002 LT/1/97/1271/065 GLAXOSMITHKLINE LIETUVA
UAB
LT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 38/44
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
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807181 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807193 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807205 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807217 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807229 GLAXOSMITHKLINE S.P.A. IT
Lamictal 5 mg compresse
masticabili/dispersibili
NL/H/1539/002 027807231 GLAXOSMITHKLINE S.P.A. IT
Lamictal 2 mg kramtomosios
ar disperguojamosios tabletes
NL/H/1539/001 LT/1/97/1271/060 GLAXOSMITHKLINE LIETUVA
UAB
LT
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/08 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/09 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/10 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/11 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/12 THE WELLCOME
FOUNDATION LTD
RO
Lamictal 5 mg comprimate
masticabile/dispersabile
NL/H/1539/002 1746/2009/13 THE WELLCOME
FOUNDATION LTD
RO
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 39/44
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
LAMOTRIGINE EG 200 mg,
comprimé dispersible ou à
croquer
not available NL30945 EG LABO LABORATOIRES
EUROGENERICS
FR
Lamictal 50 mg tablete not available HR-H-052719076 GLAXOSMITHKLINE D.O.O. HR
Labileno 100 mg comprimidos
masticables/dispersables
not available 64.943 GLAXOSMITHKLINE S.A. ES
Crisomet 50 mg comprimidos
masticables/dispersables
not available 64.464 GLAXOSMITHKLINE S.A. ES
Crisomet 100 mg comprimidos
masticables/dispersables
not available 64.462 GLAXOSMITHKLINE S.A. ES
Crisomet 25 mg comprimidos
masticables/dispersables
not available 63.747 GLAXOSMITHKLINE S.A. ES
Crisomet 200 mg comprimidos
masticables/dispersables
not available 64.463 GLAXOSMITHKLINE S.A. ES
Labileno 25 mg comprimidos
masticables/dispersables.
not available 63.288 GLAXOSMITHKLINE S.A. ES
Labileno 200 mg comprimidos
masticables/dispersables.
not available 65.283 GLAXOSMITHKLINE S.A. ES
Labileno 50 mg comprimidos
masticables/dispersables
not available 65.284 GLAXOSMITHKLINE S.A. ES
Lamotrigin GSK 5 mg
Tabletten
(kaubar/suspendierbar)
not available 1-25285 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamotrigin GSK 25 mg
Tabletten
(kaubar/suspendierbar)
not available 1-25286 GLAXOSMITHKLINE PHARMA
GMBH.
AT
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 40/44
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
Lamotrigin GSK 50 mg
Tabletten
(kaubar/suspendierbar)
not available 1-25287 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamotrigin GSK 100 mg
Tabletten
(kaubar/suspendierbar)
not available 1-25288 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamotrigin GSK 200 mg
Tabletten
(kaubar/suspendierbar)
not available 1-25289 GLAXOSMITHKLINE PHARMA
GMBH.
AT
Lamictal 25 mg tablete not available HR-H-211198060 GLAXOSMITHKLINE D.O.O. HR
Lamictal 100 mg tablete not available HR-H-695293019 GLAXOSMITHKLINE D.O.O. HR
LAMICTAL 5 mg tablete za
žvakanje/tablete za oralnu
suspenziju
not available HR-H-287736527 GLAXOSMITHKLINE D.O.O. HR
Lamitrin 50 mg tabletta not available OGYI-T-8805/04 GLAXOSMITHKLINE KFT. HU
Lamitrin 50 mg tabletta not available OGYI-T-8805/10 GLAXOSMITHKLINE KFT. HU
Lamitrin 100 mg tabletta not available OGYI-T-8805/06 GLAXOSMITHKLINE KFT. HU
Lamitrin 100 mg tabletta not available OGYI-T-8805/11 GLAXOSMITHKLINE KFT. HU
Lamitrin 200 mg tabletta not available OGYI-T-8805/08 GLAXOSMITHKLINE KFT. HU
Lamitrin 200 mg tabletta not available OGYI-T-8805/12 GLAXOSMITHKLINE KFT. HU
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 41/44
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
Lamitrin 25 mg tabletta not available OGYI-T-8805/02 GLAXOSMITHKLINE KFT. HU
Lamitrin 25 mg tabletta not available OGYI-T-8805/09 GLAXOSMITHKLINE KFT. HU
Lambipol 25 mg kauw-
/dispergeerbare tabletten
NL/H/2051/001 BE 266052 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/001 BE 266052 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 25 mg kauw-
/dispergeerbare tabletten
NL/H/2051/001 BE 266077 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/001 BE 266077 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 50 mg kauw-
/dispergeerbare tabletten
NL/H/2051/002 BE 266095 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 50 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/002 BE 266095 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 100 mg kauw-
/dispergeerbare tabletten
NL/H/2051/003 BE 266122 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 100 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/003 BE 266122 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 42/44
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
Lambipol 200 mg kauw-
/dispergeerbare tabletten
NL/H/2051/004 BE 266156 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 200 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/004 BE 266156 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/001 260/05/01/0026 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 25 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/001 260/05/01/0027 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 50 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/002 260/05/01/0028 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 100 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/003 260/05/01/0029 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 200 mg
Kautabletten/Tabletten zur
Herstellung einer Suspension
zum Einnehmen
NL/H/2051/004 260/05/01/0030 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 43/44
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
Lambipol 50 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/2051/002 RVG 107454 GLAXOSMITHKLINE B.V. NL
Lambipol 50 mg comprimés à
croquer/dispersibles
NL/H/2051/002 BE 266095 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 50 mg comprimés à
croquer/dispersibles
NL/H/2051/002 260/05/01/0028 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 100 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/2051/003 RVG 107455 GLAXOSMITHKLINE B.V. NL
Lambipol 100 mg comprimés
à croquer/dispersibles
NL/H/2051/003 BE 266122 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 100 mg comprimés
à croquer/dispersibles
NL/H/2051/003 260/05/01/0029 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 200 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/2051/004 RVG 107456 GLAXOSMITHKLINE B.V. NL
Lambipol 200 mg comprimés
à croquer/dispersibles
NL/H/2051/004 BE 266156 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 200 mg comprimés
à croquer/dispersibles
NL/H/2051/004 260/05/01/0030 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 25 mg,
kauwtabletten/dispergeerbare
tabletten
NL/H/2051/001 RVG 107451 GLAXOSMITHKLINE B.V. NL
Lambipol 25 mg comprimés à
croquer/dispersibles
NL/H/2051/001 BE 266077 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
Lambipol 25 mg comprimés à
croquer/dispersibles
NL/H/2051/001 BE 266052 GLAXOSMITHKLINE
PHARMACEUTICALS SA
BE
List of nationally authorised medicinal products
lamotrigine - PSUSA/00001825/201711
EMA/600046/2018 Page 44/44
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
Lambipol 25 mg comprimés à
croquer/dispersibles
NL/H/2051/001 260/05/01/0026 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lambipol 25 mg comprimés à
croquer/dispersibles
NL/H/2051/001 260/05/01/0027 GLAXOSMITHKLINE
PHARMACEUTICALS SA
LU
Lamotrigin Aristo® 25 mg
Tabletten zur Herstellung
einer Suspension zum
Einnehmen
DE/H/0720/003 61971.02.00 ARISTO PHARMA GMBH (ART
57)
DE
Lamotrigin Aristo® 50 mg
Tabletten zur Herstellung
einer Suspension zum
Einnehmen
DE/H/0720/004 61971.03.00 ARISTO PHARMA GMBH (ART
57)
DE
Lamotrigin Aristo® 100 mg
Tabletten zur Herstellung
einer Suspension zum
Einnehmen
DE/H/0720/005 61971.04.00 ARISTO PHARMA GMBH (ART
57)
DE
Lamotrigin Aristo® 200 mg
Tabletten zur Herstellung
einer Suspension zum
Einnehmen
DE/H/0720/006 61971.05.00 ARISTO PHARMA GMBH (ART
57)
DE
