01 September 2017 EMA/590620/2017 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: donepezil
Procedure no. PSUSA/00001160/201611
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
DoneLiquid GeriaSan® 2 mg/ml Lösung zum Einnehmen
DE/H/4450/001
95160.00.00
Donepezil hydrochloride 2mg/ml oral solution Donepezil hydrochloride 2mg/ml oral solution Donepezil hydrochloride 5 mg Film-coated Tablets Donepezil hydrochloride 10 mg Film-coated Tablets ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili Aricept 10 mg filmomhulde tabletten Aricept 5 mg filmomhulde tabletten ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili Aricept 5 mg filmomhulde tabletten Aricept 10 mg filmomhulde
UK/H/6150/001
PL 41344/0017
UK/H/6150/001
PL 41344/0017
not available
PL 42930/0003
not available
PL 42930/0004
UK/H/0182/003
List of nationally authorised medicinal products EMA/590620/2017
MAH of product in the member state
Member State where product is authorised DE
033254210
INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH COLONIS PHARMA LIMITED COLONIS PHARMA LIMITED WILCARE PHARMA LIMITED WILCARE PHARMA LIMITED PFIZER LIMITED
UK/H/0182/003
033254234
PFIZER LIMITED
IT
UK/H/0182/002
BE185805
BE
UK/H/0182/001
BE295653
UK/H/0182/003
033254196
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/003
033254246
PFIZER LIMITED
IT
UK/H/0182/003
033254222
PFIZER LIMITED
IT
UK/H/0182/003
033254208
PFIZER LIMITED
IT
UK/H/0182/003
033254259
PFIZER LIMITED
IT
UK/H/0182/004
033254285
PFIZER LIMITED
IT
UK/H/0182/003
033254261
PFIZER LIMITED
IT
UK/H/0182/001
BE185814
BE
UK/H/0182/002
BE295644
PFIZER S.A. (BELGIUM) PFIZER S.A.
UK UK UK UK IT
BE IT
BE
Page 2/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
tabletten
MAH of product in the member state
Member State where product is authorised
(BELGIUM)
ARICEPT 10 mg compresse orodispersibili Aricept 5 mg filmdragerade tabletter Aricept Evess 5 mg tabletter, munsönderfallande ARICEPT 10 mg compresse orodispersibili Aricept 10 mg filmdragerade tabletter ARICEPT 10 mg compresse orodispersibili Aricept 10 mg Filmtabletten
UK/H/0182/004
033254347
PFIZER LIMITED
IT
UK/H/0182/001
12776
PFIZER OY
FI
UK/H/0182/003
21525
PFIZER OY
FI
UK/H/0182/004
033254350
PFIZER LIMITED
IT
UK/H/0182/002
12777
PFIZER OY
FI
UK/H/0182/004
033254323
PFIZER LIMITED
IT
UK/H/0182/002
BE295644
BE
Aricept 10 mg Filmtabletten
UK/H/0182/002
BE185805
Aricept 5 mg Filmtabletten
UK/H/0182/001
BE295653
ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili Aricept Evess 10 mg tabletter, munsönderfallande ARICEPT 10 mg compresse orodispersibili ARICEPT 5 mg Filmtabletten
UK/H/0182/004
033254311
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/004
033254335
PFIZER LIMITED
IT
UK/H/0182/004
21526
PFIZER OY
FI
UK/H/0182/004
033254297
PFIZER LIMITED
IT
UK/H/0182/001
BE185814
BE
ARICEPT 10 mg compresse orodispersibili Aricept 5 mg Filmtabletten
UK/H/0182/004
033254309
PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/001
0194/11041097
LU
ARICEPT 5 mg, comprimé pelliculé
UK/H/0182/001
34009 568 390 8 7
PFIZER S.A. (BELGIUM) LABORATOIRES EISAI S.A
List of nationally authorised medicinal products EMA/590620/2017
BE BE IT
IT
FR
Page 3/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
ARICEPT 10 mg, comprimé pelliculé ARICEPT 5 mg, comprimé orodispersible ARICEPT 10 mg, comprimé orodispersible ARICEPT 10 mg comprimés pelliculés Aricept 10 mg Filmtabletten
UK/H/0182/002
34009 568 391 4 8
UK/H/0182/003
34009 380 835 2 1
UK/H/0182/004
34009 380 836 9 9
UK/H/0182/002
2011041096
UK/H/0182/002
2011041096
Aricept 10 mg filmdragerade tabletter Aricept® 10 mg - Filmtabletten
UK/H/0182/002
13568
UK/H/0182/002
1-22057
ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg comprimidos revestidos por película ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg film coated tablets
UK/H/0182/003
033254071
UK/H/0182/001
2574788
UK/H/0182/003
033254083
UK/H/0182/001
PA 822/2/1
ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg comprimidos revestidos por película ARICEPT 10 mg, επικαλυμμένα με λεπτό υμένιο δισκία ARICEPT 10 mg film coated tablets
UK/H/0182/003
033254032
UK/H/0182/001
2574580
UK/H/0182/002
75519/20-11-2007
UK/H/0182/002
PA 822/2/2
List of nationally authorised medicinal products EMA/590620/2017
MAH of product in the member state
Member State where product is authorised
LABORATOIRES EISAI S.A LABORATOIRES EISAI S.A LABORATOIRES EISAI S.A PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER AB
FR
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER LIMITED
AT
LABORATÓRIOS PFIZER, LDA. PFIZER LIMITED
PT
PFIZER HEALTHCARE IRELAND PFIZER LIMITED
IE
LABORATÓRIOS PFIZER, LDA. PFIZER HELLAS, A.E. PFIZER HEALTHCARE IRELAND
PT
FR FR LU LU SE
IT
IT
IT
GR IE
Page 4/15
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
Aricept Evess 10 mg tabletti, suussa hajoava Aricept, tabletter, filmovertrukne
UK/H/0182/004
21526
PFIZER OY
FI
UK/H/0182/001
18797
PFIZER APS
DK
ARICEPT 10 mg comprimidos revestidos por película Aricept, 10 mg, comprimidos orodispersíveis Donepezil Pfizer 10 mg Filmtabletten
UK/H/0182/002
2574887
PT
UK/H/0182/004
5716188
UK/H/4587/002
1-30377
Aricept Evess 5 mg tabletti, suussa hajoava Aricept, 10 mg, comprimidos orodispersíveis ARICEPT Δισκίο διασπειρόμενο στο στόμα, 5 mg ARICEPT 5 mg compresse orodispersibili Donepezil Pfizer 5 mg Filmtabletten
UK/H/0182/003
21525
LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER OY
UK/H/0182/004
5716089
PT
UK/H/0182/003
81151/24-11-2011
UK/H/0182/003
033254172
LABORATÓRIOS PFIZER, LDA. PFIZER HELLAS, A.E. PFIZER LIMITED
UK/H/4587/001
1-30376
AT
Aricept, 5 mg, comprimidos orodispersíveis Aricept 5 mg munsönderfallande tablett ARICEPT 10 mg comprimidos revestidos por película Aricept 5 mg filmdragerade tabletter ARICEPT 5 mg comprimidos revestidos por película
UK/H/0182/003
5709688
UK/H/0182/003
22917
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. LABORATÓRIOS PFIZER, LDA. PFIZER AB
UK/H/0182/002
2574986
PT
UK/H/0182/001
13567
LABORATÓRIOS PFIZER, LDA. PFIZER AB
UK/H/0182/001
2574689
LABORATÓRIOS PFIZER, LDA.
PT
List of nationally authorised medicinal products EMA/590620/2017
PT AT
FI
GR IT
PT SE
SE
Page 5/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
Aricept, 5 mg, comprimidos orodispersíveis Aricept® Evess 5 mg Schmelztabletten
UK/H/0182/003
5715784
UK/H/0182/003
1-26553
Aricept® 5 mg - Filmtabletten
UK/H/0182/001
1-22056
Aricept, 5 mg, comprimidos orodispersíveis ARICEPT EVESS 5 mg orodispersible tablet
UK/H/0182/003
5715982
UK/H/0182/003
PA 822/2/3
ARICEPT 5 mg compresse orodispersibili Aricept, tabletter, filmovertrukne
UK/H/0182/003
MAH of product in the member state
Member State where product is authorised PT
033254095
LABORATÓRIOS PFIZER, LDA. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. LABORATÓRIOS PFIZER, LDA. PFIZER HEALTHCARE IRELAND PFIZER LIMITED
UK/H/0182/002
18798
PFIZER APS
DK
ARICEPT EVESS 10 mg orodispersible tablet
UK/H/0182/004
PA 822/2/4
IE
ARICEPT 10 mg tabletti, kalvopäällysteinen ARICEPT 5 mg, επικαλυμμένα με λεπτό υμένιο δισκία Aricept, 10 mg, comprimidos orodispersíveis Aricept 10 mg munsönderfallande tablett Aricept® Evess 10 mg Schmelztabletten
UK/H/0182/002
12777
PFIZER HEALTHCARE IRELAND PFIZER OY
UK/H/0182/001
75518/20-11-2007
GR
UK/H/0182/004
5716287
UK/H/0182/004
22918
PFIZER HELLAS, A.E. LABORATÓRIOS PFIZER, LDA. PFIZER AB
UK/H/0182/004
1-26554
PFIZER CORPORATION AUSTRIA GESELLSCHAFT
AT
List of nationally authorised medicinal products EMA/590620/2017
AT
AT
PT IE IT
FI
PT SE
Page 6/15
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
M.B.H. ARICEPT Δισκίο διασπειρόμενο στο στόμα, 10 mg Aricept, 5 mg, comprimidos orodispersíveis ARICEPT 5 mg compresse rivestite con film ARICEPT 5 mg compresse orodispersibili Aricept, 10 mg, comprimidos orodispersíveis ARICEPT 5 mg comprimés pelliculés ARICEPT 5 mg tabletti, kalvopäällysteinen ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili Aricept Evess, smeltetabletter
UK/H/0182/004
81152/24-11-2011
GR
033254018
PFIZER HELLAS, A.E. LABORATÓRIOS PFIZER, LDA. PFIZER LIMITED
UK/H/0182/003
5715883
UK/H/0182/001 UK/H/0182/003
033254057
PFIZER LIMITED
IT
UK/H/0182/004
5709787
PT
UK/H/0182/001
0194/11041097
UK/H/0182/001
12776
LABORATÓRIOS PFIZER, LDA. PFIZER S.A. (BELGIUM) PFIZER OY
UK/H/0182/003
033254044
PFIZER LIMITED
IT
UK/H/0182/003
033254069
PFIZER LIMITED
IT
UK/H/0182/004
38480
PFIZER APS
DK
Aricept Evess, smeltetabletter
UK/H/0182/003
38479
PFIZER APS
DK
ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse rivestite con film ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse
UK/H/0182/004
033254121
PFIZER LIMITED
IT
UK/H/0182/004
033254107
PFIZER LIMITED
IT
UK/H/0182/004
033254145
PFIZER LIMITED
IT
UK/H/0182/004
033254119
PFIZER LIMITED
IT
UK/H/0182/002
033254020
PFIZER LIMITED
IT
UK/H/0182/004
033254184
PFIZER LIMITED
IT
UK/H/0182/004
033254160
PFIZER LIMITED
IT
List of nationally authorised medicinal products EMA/590620/2017
PT IT
LU FI
Page 7/15
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
orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 5 mg film coated tablets ARICEPT 10 mg film coated tablets Aricept Evess 5 mg orodispersible tablet Aricept Evess 10 mg orodispersible tablet Aricept 5mg Filmtabletten
UK/H/0182/004
033254158
PFIZER LIMITED
IT
UK/H/0182/001
PL 10555/0006
EISAI LTD
UK
UK/H/0182/002
PL 10555/0007
EISAI LTD
UK
UK/H/0182/003
PL 10555/0019
EISAI LTD
UK
UK/H/0182/004
PL 10555/0020
EISAI LTD
UK
UK/H/0182/001
40652.00.00
EISAI GMBH
DE
Aricept 10mg Filmtabletten
UK/H/0182/002
40652.01.00
EISAI GMBH
DE
ARICEPT 10 mg, comprimé pelliculé ARICEPT 5 mg, comprimé orodispersible ARICEPT 10 mg, comprimé orodispersible ARICEPT 10 mg comprimés pelliculés ARICEPT 5 mg comprimés pelliculés ARICEPT 10 mg comprimés pelliculés ARICEPT 5 mg comprimés pelliculés ARICEPT 5 mg filmom obložene tablete ARICEPT 10 mg filmom obložene tablete ARICEPT Evess 10 mg raspadljive tablete za usta ARICEPT Evess 5 mg raspadljive
UK/H/0182/02
3400934449505
FR
UK/H/0182/03
3400937306096
UK/H/0182/04
3400937306447
UK/H/0182/002
BE295644
UK/H/0182/001
BE295653
UK/H/0182/002
BE185805
UK/H/0182/001
BE185814
not available
UP/I-530-09/12-02/476
not available
UP/I-530-09/12-02/477
not available
UP/I-530-09/13-02/81
not available
UP/I-530-09/13-02/80
LABORATOIRES EISAI S.A LABORATOIRES EISAI S.A LABORATOIRES EISAI S.A PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER CROATIA D.O.O. PFIZER CROATIA D.O.O. PFIZER CROATIA D.O.O. PFIZER CROATIA
List of nationally authorised medicinal products EMA/590620/2017
FR FR BE BE BE BE HR HR HR HR
Page 8/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
tablete za usta ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili Aricept 10 mg filmomhulde tabletten Aricept 5 mg filmomhulde tabletten ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 5 mg compresse orodispersibili Aricept 5 mg filmomhulde tabletten Aricept 10 mg filmomhulde tabletten ARICEPT 10 mg compresse orodispersibili Aricept 5 mg filmdragerade tabletter ARICEPT 10 mg compresse orodispersibili
List of nationally authorised medicinal products EMA/590620/2017
MAH of product in the member state
Member State where product is authorised
D.O.O. UK/H/0182/003
033254210
PFIZER LIMITED
IT
UK/H/0182/003
033254234
PFIZER LIMITED
IT
UK/H/0182/002
BE185805
BE
UK/H/0182/001
BE295653
UK/H/0182/003
033254196
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/003
033254246
PFIZER LIMITED
IT
UK/H/0182/003
033254222
PFIZER LIMITED
IT
UK/H/0182/003
033254208
PFIZER LIMITED
IT
UK/H/0182/003
033254259
PFIZER LIMITED
IT
UK/H/0182/003
033254273
PFIZER LIMITED
IT
UK/H/0182/004
033254285
PFIZER LIMITED
IT
UK/H/0182/003
033254261
PFIZER LIMITED
IT
UK/H/0182/001
BE185814
BE
UK/H/0182/002
BE295644
UK/H/0182/004
033254347
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/001
12776
PFIZER OY
FI
UK/H/0182/004
033254350
PFIZER LIMITED
IT
BE IT
BE IT
Page 9/15
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
ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili Aricept 10 mg Filmtabletten
UK/H/0182/004
033254362
PFIZER LIMITED
IT
UK/H/0182/004
033254323
PFIZER LIMITED
IT
UK/H/0182/002
BE185805
BE
ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili Aricept Evess 5 mg comprimate orodispersabile Aricept Evess 10 mg comprimate orodispersabile ARICEPT 10 mg filmsko obložene tablete ARICEPT 5 mg filmsko obložene tablete Aricept® 10 mg - Filmtabletten
UK/H/0182/004
033254311
PFIZER S.A. (BELGIUM) PFIZER LIMITED
UK/H/0182/004
033254335
PFIZER LIMITED
IT
UK/H/0182/004
033254297
PFIZER LIMITED
IT
UK/H/0182/004
033254309
PFIZER LIMITED
IT
not available
7571/2015/02
RO
not available
7572/2015/02
not available
H/98/00209/002
not available
H/98/00209/001
UK/H/0182/002
1-22057
ARICEPT 5 mg compresse orodispersibili АРИСЕПТ 5 mg филмирани таблетки ARICEPT 10mg comprimidos recubiertos con película ARICEPT 5 mg compresse orodispersibili
UK/H/0182/003
033254071
PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER LUXEMBOURG SARL PFIZER LUXEMBOURG SARL PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER LIMITED
not available
9800177
BG
not available
61.870
PFIZER EUROPE MA EEIG PFIZER, S.L.
UK/H/0182/003
033254083
PFIZER LIMITED
IT
List of nationally authorised medicinal products EMA/590620/2017
IT
RO SI SI AT
IT
ES
Page 10/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
ARICEPT 5 mg film coated tablets
UK/H/0182/001
PA 822/2/1
ARICEPT 5 mg compresse orodispersibili ARICEPT 10 mg, επικαλυμμένα με λεπτό υμένιο δισκία ARICEPT 10 mg film coated tablets
UK/H/0182/003
033254032
UK/H/0182/002
75519/20-11-2007
UK/H/0182/002
PA 822/2/2
Aricept Evess 10 mg tabletti, suussa hajoava Aricept, tabletter, filmovertrukne
UK/H/0182/004
Aricept, 10 mg, comprimidos orodispersíveis АРИСЕПТ 10 mg филмирани таблетки Donepezil Pfizer 10 mg Filmtabletten
Aricept Evess 5 mg tabletti, suussa hajoava Aricept, 5 mg õhukese polümeerikattega tabletid ARICEPT 5 mg potahované tablety Aricept, 10 mg, comprimidos orodispersíveis ARICEPT Δισκίο διασπειρόμενο στο στόμα, 5 mg Aricept, 10 mg filmuhúðaðar töflur ARICEPT 5 mg compresse
List of nationally authorised medicinal products EMA/590620/2017
MAH of product in the member state
Member State where product is authorised
PFIZER HEALTHCARE IRELAND PFIZER LIMITED
IE
GR
21526
PFIZER HELLAS, A.E. PFIZER HEALTHCARE IRELAND PFIZER OY
UK/H/0182/001
18797
PFIZER APS
DK
UK/H/0182/004
5716188
PT
not available
9800178
UK/H/4587/002
1-30377
UK/H/0182/003
21525
LABORATÓRIOS PFIZER, LDA. PFIZER EUROPE MA EEIG PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER OY
not available
322300
EE
not available
06/121/98-C
UK/H/0182/004
5716089
UK/H/0182/003
81151/24-11-2011
not available
970077 (IS)
PFIZER EUROPE MA EEIG PFIZER, SPOL. S R.O. LABORATÓRIOS PFIZER, LDA. PFIZER HELLAS, A.E. PFIZER APS
UK/H/0182/003
033254172
PFIZER LIMITED
IT
IT
IE FI
BG AT
FI
CZ PT GR IS
Page 11/15
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
orodispersibili Donepezil Pfizer 5 mg Filmtabletten
UK/H/4587/001
1-30376
AT
22917
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. LABORATÓRIOS PFIZER, LDA. PFIZER AB
Aricept, 5 mg, comprimidos orodispersíveis Aricept 5 mg munsönderfallande tablett Aricept® 5 mg filmdrasjerte tabletter Aricept, 5 mg, comprimidos orodispersíveis Aricept® Evess 5 mg Schmelztabletten
UK/H/0182/003
5709688
UK/H/0182/003 not available
96-3400
PFIZER AS
NO
UK/H/0182/003
5715784
PT
UK/H/0182/003
1-26553
Aricept® 5 mg - Filmtabletten
UK/H/0182/001
1-22056
Aricept, 5 mg, comprimidos orodispersíveis ARICEPT EVESS 5 mg orodispersible tablet
UK/H/0182/003
5715982
UK/H/0182/003
PA 822/2/3
ARICEPT 5 mg compresse orodispersibili ARICEPT FLAS 10 mg comprimidos bucodispersables Aricept, tabletter, filmovertrukne
UK/H/0182/003
033254095
LABORATÓRIOS PFIZER, LDA. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. LABORATÓRIOS PFIZER, LDA. PFIZER HEALTHCARE IRELAND PFIZER LIMITED
not available
68.214
PFIZER, S.L.
ES
UK/H/0182/002
18798
PFIZER APS
DK
ARICEPT EVESS 10 mg
UK/H/0182/004
PA 822/2/4
PFIZER
IE
List of nationally authorised medicinal products EMA/590620/2017
PT SE
AT
AT
PT IE IT
Page 12/15
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
orodispersible tablet
MAH of product in the member state
Member State where product is authorised
ARICEPT 10 mg tabletti, kalvopäällysteinen ARICEPT 10 mg filmtabletta
UK/H/0182/002
12777
HEALTHCARE IRELAND PFIZER OY
not available
OGYI-T-6059/02
PFIZER KFT.
HU
ARICEPT 5 mg, επικαλυμμένα με λεπτό υμένιο δισκία Aricept, 10 mg, comprimidos orodispersíveis Aricept 10 mg munsönderfallande tablett Aricept® Evess 10 mg Schmelztabletten
UK/H/0182/001
75518/20-11-2007
GR
UK/H/0182/004
5716287
UK/H/0182/004
22918
PFIZER HELLAS, A.E. LABORATÓRIOS PFIZER, LDA. PFIZER AB
UK/H/0182/004
1-26554
AT
ARICEPT Δισκίο διασπειρόμενο στο στόμα, 10 mg ARICEPT 5 mg filmtabletta
UK/H/0182/004
81152/24-11-2011
not available
OGYI-T-6059/01
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER HELLAS, A.E. PFIZER KFT.
Aricept, 5 mg, comprimidos orodispersíveis ARICEPT 5 mg compresse rivestite con film ARICEPT 5mg comprimidos recubiertos con película ARICEPT 5 mg compresse orodispersibili Aricept, 10 mg õhukese polümeerikattega tabletid Aricept, 10 mg, comprimidos orodispersíveis ARICEPT 5 mg apvalkotās tabletes ARICEPT 5 mg compresse orodispersibili
UK/H/0182/003
5715883
PT
UK/H/0182/001
033254018
LABORATÓRIOS PFIZER, LDA. PFIZER LIMITED
not available
61.869
PFIZER, S.L.
ES
UK/H/0182/003
033254057
PFIZER LIMITED
IT
not available
322400
EE
UK/H/0182/004
5709787
not available
99-0134
PFIZER EUROPE MA EEIG LABORATÓRIOS PFIZER, LDA. PFIZER LIMITED
UK/H/0182/003
033254044
PFIZER LIMITED
IT
List of nationally authorised medicinal products EMA/590620/2017
FI
PT SE
GR HU
IT
PT LV
Page 13/15
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
ARICEPT 5 mg compresse orodispersibili ARICEPT FLAS 5 mg comprimidos bucodispersables Aricept® 10 mg filmdrasjerte tabletter ARICEPT 10 mg apvalkotās tabletes ARICEPT 5 mg, επικαλυμμένα με λεπτό υμένιο δισκία Aricept Evess, smeltetabletter
UK/H/0182/003
033254069
PFIZER LIMITED
IT
not available
68.213
PFIZER, S.L.
ES
not available
96-3401
PFIZER AS
NO
not available
99-0135
PFIZER LIMITED
LV
not available
17824
CY
UK/H/0182/004
38480
PFIZER HELLAS, A.E. PFIZER APS
Aricept Evess, smeltetabletter
UK/H/0182/003
38479
PFIZER APS
DK
ARICEPT 10 mg, επικαλυμμένα με λεπτό υμένιο δισκία Aricept Evess 5 mg munndreifitöflur ARICEPT 10 mg potahované tablety Aricept Evess 10 mg munndreifitöflur Aricept, 5 mg, tabletki powlekane Aricept, 10 mg, tabletki powlekane ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse orodispersibili ARICEPT 10 mg compresse rivestite con film
not available
17825
CY
not available
IS/1/05/058/01
PFIZER HELLAS, A.E. PFIZER APS
not available
06/122/98-C
CZ
not available
IS/1/05/058/02
PFIZER, SPOL. S R.O. PFIZER APS
not available
7528
PL
not available
7529
UK/H/0182/004
033254121
PFIZER EUROPE MA EEIG PFIZER EUROPE MA EEIG PFIZER LIMITED
UK/H/0182/004
033254107
PFIZER LIMITED
IT
UK/H/0182/004
033254145
PFIZER LIMITED
IT
UK/H/0182/004
033254119
PFIZER LIMITED
IT
UK/H/0182/002
033254020
PFIZER LIMITED
IT
List of nationally authorised medicinal products EMA/590620/2017
DK
IS
IS
PL IT
Page 14/15
Product Name (in authorisation country) ARICEPT 10 mg orodispersibili ARICEPT 10 mg orodispersibili ARICEPT 10 mg orodispersibili ARICEPT 10 mg orodispersibili
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
compresse
UK/H/0182/004
033254184
PFIZER LIMITED
IT
compresse
UK/H/0182/004
033254160
PFIZER LIMITED
IT
compresse
UK/H/0182/004
033254158
PFIZER LIMITED
IT
compresse
UK/H/0182/004
033254133
PFIZER LIMITED
IT
List of nationally authorised medicinal products EMA/590620/2017
Page 15/15
