European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 September 2017. EMA/
13 September 2017 EMA/727763/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products Active substance(s): dexlansoprazole, lansoprazole
Procedure No.: PSUSA/00001827/201612
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
Agopton 15 mg - Kapseln Agopton 15 mg - Kapseln Agopton 15 mg Kapseln Agopton 15 mg Kapseln Agopton 30 mg - Kapseln Agopton 30 mg - Kapseln Agopton 30 mg Kapseln Agopton 30 mg Kapseln Agopton Tabs 15 mg Schmelztabletten Agopton Tabs 15 mg Schmelztabletten Agopton Tabs 30 mg Schmelztabletten Agopton Tabs 30 mg Schmelztabletten Dakar 15 mg , Maagsapresistente capsule, Dakar 15 mg , Maagsapresistente capsule, Dakar 15 mg , Maagsapresistente capsule, Dakar 15 mg , Maagsapresistente capsule, Dakar 15 mg gélules gastro-résistants Dakar 15 mg gélules gastro-résistants Dakar 30 mg , Maagsapresistente capsule, Dakar 30 mg , Maagsapresistente capsule, Dakar 30 mg , Maagsapresistente capsule, Dakar 30 mg gélules gastro-résistants Dakar 30 mg gélules gastro-résistants Dakar 30 mg gélules gastro-résistants Dostab Flas 15 mg comprimidos bucodispersables Dostab Flas 30 mg comprimidos bucodispersables Duomate Flas 15 mg comprimidos bucodispersables Duomate Flas 30 mg comprimidos bucodispersables Lansobene 15 mg - Kapseln
EMA/727763/2017
hard hard hard hard
hard hard hard
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/003 DE/H/1699/003 DE/H/1699/004 DE/H/1699/004 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 not available
1-20544 1-20544 36286.01.00 36286.01.00 1-20545 1-20545 36286.00.00 36286.00.00 38409.01.00 38409.01.00 38409.00.00 38409.00.00 BE184107 BE184107 BE184107 BE184107 0240122 0240119 NOT APPLICABLE BE159695 BE159695 BE159695 0231879 0204823 78395
TAKEDA PHARMA GES.M.B.H. TAKEDA PHARMA GES.M.B.H. TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA PHARMA GES.M.B.H. TAKEDA PHARMA GES.M.B.H. TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM SANOFI BELGIUM LABORATORIOS SALVAT, S.A.
AT AT DE DE AT AT DE DE DE DE DE DE BE BE BE BE LU LU BE BE BE BE LU LU ES
not available
78396
LABORATORIOS SALVAT, S.A.
ES
ES/H/0217/001
77740
LABORATORIOS SALVAT, S.A.
ES
ES/H/0217/002
77741
LABORATORIOS SALVAT, S.A.
ES
not available
1-25531
RATIOPHARM ARZNEIMITTEL
AT
is authorised
Page 2/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
Lansobene 30 mg - Kapseln
not available
1-25532
Lansoprazol "Pensa", hårde enterokapsler 15 mg Lansoprazol "Pensa", hårde enterokapsler 30 mg Lansoprazol AbZ 15 mg magensaftresistente Hartkapseln Lansoprazol AbZ 30 mg magensaftresistente Hartkapseln Lansoprazol Flas Salvat 15 mg comprimidos bucodispersables Lansoprazol Flas Salvat 30 mg comprimidos bucodispersables Lansoprazol Pensa 15 mg enterokapslar, hårda Lansoprazol Pensa 15 mg enterokapsler, harde Lansoprazol Pensa 15 mg magensaftresistente Hartkapseln Lansoprazol Pensa 30 mg enterokapslar, hårda Lansoprazol Pensa 30 mg enterokapsler, harde Lansoprazol Pensa 30 mg magensaftresistente Hartkapseln Lansoprazol Ranbaxy 15 mg munsönderfallande tablett Lansoprazol Ranbaxy 30 mg munsönderfallande tablett Lansoprazol Teva 15 mg enterosolventní tvrdé tobolky Lansoprazol Teva 15 mg, maagsapresistente capsules, hard Lansoprazol Teva 30 mg, maagsapresistente capsules, hard Lansoprazol Teva 30mg enterosolventní tvrdé tobolky
SE/H/1133/001 SE/H/1133/002 DE/H/3931/001
48831 48832 90591.00.00
VERTRIEBS-GMBH RATIOPHARM ARZNEIMITTEL VERTRIEBS-GMBH PENSA PHARMA AB PENSA PHARMA AB ABZ-PHARMA GMBH
DE/H/3931/002
90592.00.00
ABZ-PHARMA GMBH
DE
ES/H/0213/001
77.738
LABORATORIOS SALVAT, S.A.
ES
ES/H/0213/002
77.739
LABORATORIOS SALVAT, S.A.
ES
SE/H/1133/001 SE/H/1133/001 SE/H/1133/001
28015 13-9506 85022.00.00
PENSA PHARMA AB PENSA PHARMA AB PENSA PHARMA GMBH
SE NO DE
SE/H/1133/002 SE/H/1133/002 SE/H/1133/002
28016 13-9507 85023.00.00
PENSA PHARMA AB PENSA PHARMA AB PENSA PHARMA GMBH
SE NO DE
ES/H/0213/001
48457
RANBAXY UK LTD
SE
ES/H/0213/002
48458
RANBAXY UK LTD
SE
DE/H/3899/001/D C DE/H/3931/001
09/045/15-C
CZ
RVG 114235
TEVA PHARMACEUTICALS CR, S.R.O. TEVA NEDERLAND B.V.
DE/H/3931/002
RVG 114236
TEVA NEDERLAND B.V.
NL
DE/H/3899/002
09/046/15-C
TEVA PHARMACEUTICALS CR, S.R.O.
CZ
Product Name (in authorisation country)
EMA/727763/2017
is authorised AT DK DK DE
NL
Page 3/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
15 mg Cápsulas
not available
5606850
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606868
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606876
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606900
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606918
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606926
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606850
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606868
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606876
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606900
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606918
BLUESCIENCE UNIPESSOAL LDA.
PT
15 mg Cápsulas
not available
5606926
BLUESCIENCE UNIPESSOAL LDA.
PT
30 mg Cápsulas
not available
5606942
BLUESCIENCE UNIPESSOAL LDA.
PT
30 mg Cápsulas
not available
5606959
BLUESCIENCE UNIPESSOAL LDA.
PT
30 mg Cápsulas
not available
5606967
BLUESCIENCE UNIPESSOAL LDA.
PT
30 mg Cápsulas
not available
5606975
BLUESCIENCE UNIPESSOAL LDA.
PT
30 mg Cápsulas
not available
5607007
BLUESCIENCE UNIPESSOAL LDA.
PT
Product Name (in authorisation country)
Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes Lansoprazol Zintem gastrorresistentes
EMA/727763/2017
is authorised
Page 4/21
Product Name (in authorisation country)
Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazol Zintem 30 mg Cápsulas gastrorresistentes Lansoprazole 15 mg Gastro-resistant Capsules Lansoprazole 15 mg orodispersible tablets Lansoprazole 30 mg Gastro-resistant Capsules Lansoprazole 30 mg orodispersible tablets Lansoprazole ratiopharm 15 mg enterokapseli, kova Lansoprazole ratiopharm 15 mg hårda enterokapslar LANSOPRAZOLE RATIOPHARM 15 mg, gélule gastrorésistante Lansoprazole ratiopharm 30 mg enterokapseli, kova Lansoprazole ratiopharm 30 mg hårda enterokapslar Lansoprazole ratiopharm 30 mg magasýruþolin hörð hylki Lansoprazole Salvat 15 mg comprimés orodispersibles Lansoprazole Salvat 30 mg comprimés orodispersibles
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
not available
5607015
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5606942
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5606959
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5606967
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5606975
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5607007
BLUESCIENCE UNIPESSOAL LDA.
PT
not available
5607015
BLUESCIENCE UNIPESSOAL LDA.
PT
not available ES/H/0213/001 not available ES/H/0213/002 DE-H-3899-001002 DE-H-3899-001002 DE/H/3899/001
PA 749/135/01 PL 14894/0728 PA 749/135/02 PL 14894/0729 33910
TEVA PHARMA B.V. RANBAXY UK LTD TEVA PHARMA B.V. RANBAXY UK LTD RATIOPHARM GMBH
IE UK IE UK FI
33910
RATIOPHARM GMBH
FI
2015120201
RATIOPHARM GMBH
LU
DE-H-3899-001002 DE-H-3899-001002 DE-H-3899-001002 ES/H/0213/001
33911
RATIOPHARM GMBH
FI
33911
RATIOPHARM GMBH
FI
IS/1/16/056/02
RATIOPHARM GMBH
IS
6 318 651 1
LABORATORIOS SALVAT, S.A.
FR
ES/H/0213/002
6 494 067 2
LABORATORIOS SALVAT, S.A.
FR
is authorised
Page 5/21
Product Name (in authorisation country)
Lansoprazole Teva 15 mg gélules gastrorésistantes Lansoprazole Teva 15 mg gélules gastrorésistantes Lansoprazole Teva 15 mg magensaftresistente Hartkapseln Lansoprazole Teva 15 mg magensaftresistente Hartkapseln Lansoprazole Teva 15 mg, maagsapresistente capsules, hard Lansoprazole Teva 15 mg, maagsapresistente capsules, hard Lansoprazole Teva 30 mg gélules gastrorésistantes Lansoprazole Teva 30 mg gélules gastrorésistantes Lansoprazole Teva 30 mg magensaftresistente Hartkapseln Lansoprazole Teva 30 mg magensaftresistente Hartkapseln Lansoprazole Teva 30 mg, maagsapresistente capsules, hard Lansoprazole Teva 30 mg, maagsapresistente capsules, hard Lansoprazole Teva Pharma 15 mg Gastroresistant Capsules, hard Lansoprazole Teva Pharma 30 mg Gastroresistant Capsules, hard Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/3899/001
BE467680
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
BE467697
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
BE467697
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
BE467680
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
BE467697
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
BE467680
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467715
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467706
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467706
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467715
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467706
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/002
BE467715
TEVA PHARMA BELGIUM N.V./S.A
BE
DE/H/3899/001
PA1986/008/001
TEVA B.V
IE
DE/H/3899/002
PA1986/008/002
TEVA B.V
IE
ES/H/0213/001
042070072
LABORATORI ALTER S.R.L.
IT
ES/H/0213/001
042070033
LABORATORI ALTER S.R.L.
IT
ES/H/0213/001
042070021
LABORATORI ALTER S.R.L.
IT
is authorised
Page 6/21
Product Name (in authorisation country)
Lansoprazolo Laboratori Alter 15 mg compresse orodispersibili Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili Lansoprazolo Laboratori Alter 30 mg compresse orodispersibili Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili Lansoprazolo TecniGen Italia 15 mg compresse orodispersibili Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili Lansoprazolo TecniGen Italia 30 mg compresse orodispersibili Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti Lansoprazolo Teva 15 mg Capsule rigide gastroresistenti
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
ES/H/0213/001
042070019
LABORATORI ALTER S.R.L.
IT
ES/H/0213/002
042070045
LABORATORI ALTER S.R.L.
IT
ES/H/0213/002
042070058
LABORATORI ALTER S.R.L.
IT
ES/H/0213/002
042070060
LABORATORI ALTER S.R.L.
IT
ES/H/0213/002
042070084
LABORATORI ALTER S.R.L.
IT
ES/H/0217/001
042069017
TECNIGEN S.R.L.
IT
ES/H/0217/001
042069029
TECNIGEN S.R.L.
IT
ES/H/0217/001
042069031
TECNIGEN S.R.L.
IT
ES/H/0217/002
042069043
TECNIGEN S.R.L.
IT
ES/H/0217/002
042069056
TECNIGEN S.R.L.
IT
ES/H/0217/002
042069068
TECNIGEN S.R.L.
IT
DE/H/3899/001
043056264
TEVA ITALIA S.R.L.
IT
DE/H/3899/001
043056252
TEVA ITALIA S.R.L.
IT
DE/H/3899/001
043056249
TEVA ITALIA S.R.L.
IT
DE/H/3899/001
043056288
TEVA ITALIA S.R.L.
IT
DE/H/3899/001
043056290
TEVA ITALIA S.R.L.
IT
DE/H/3899/001
043056276
TEVA ITALIA S.R.L.
IT
is authorised
Page 7/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
15 mg Capsule rigide
DE/H/3899/001
043056237
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056201
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056213
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056225
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056112
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056100
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056124
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056314
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056011
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056023
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056187
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056175
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056163
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056136
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056148
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056151
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056098
TEVA ITALIA S.R.L.
IT
Product Name (in authorisation country)
Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti
EMA/727763/2017
is authorised
Page 8/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
15 mg Capsule rigide
DE/H/3899/001
043056086
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056074
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056199
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056326
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056047
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056062
TEVA ITALIA S.R.L.
IT
15 mg Capsule rigide
DE/H/3899/001
043056050
TEVA ITALIA S.R.L.
IT
15 mg capsule rigide
DE/H/3899/001
043056035
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056340
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056353
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056631
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056605
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056617
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056365
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056377
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056389
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056403
TEVA ITALIA S.R.L.
IT
Product Name (in authorisation country)
Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti
EMA/727763/2017
is authorised
Page 9/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
30 mg Capsule rigide
DE/H/3899/002
043056427
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056415
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056567
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056466
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056581
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056593
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056579
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056478
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056530
TEVA ITALIA S.R.L.
IT
30 mg capsule rigide
DE/H/3899/002
043056542
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056555
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056338
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056454
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056480
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056492
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056516
TEVA ITALIA S.R.L.
IT
30 mg Capsule rigide
DE/H/3899/002
043056504
TEVA ITALIA S.R.L.
IT
Product Name (in authorisation country)
Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti Lansoprazolo Teva gastroresistenti
EMA/727763/2017
is authorised
Page 10/21
Product Name (in authorisation country)
Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti Lansoprazolo Teva 30 mg Capsule rigide gastroresistenti Lansoprazol-ratiopharm® 15 mg magensaftresistente Hartkapseln Lansoprazol-ratiopharm® 15 mg magensaftresistente Hartkapseln Lansoprazol-ratiopharm® 30 mg magensaftresistente Hartkapseln Lansoprazol-ratiopharm® 30 mg magensaftresistente Hartkapseln Lansox 15 mg capsule rigide Lansox 15 mg capsule rigide Lansox 15 mg capsule rigide Lansox 15 mg capsule rigide Lansox 15 mg capsule rigide Lansox 15 mg capsule rigide Lansox 15 mg compresse orodispersibili Lansox 15 mg compresse orodispersibili Lansox 15 mg compresse orodispersibili Lansox 15 mg compresse orodispersibili Lansox 30 mg capsule rigide Lansox 30 mg capsule rigide Lansox 30 mg capsule rigide Lansox 30 mg capsule rigide Lansox 30 mg capsule rigide
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/3899/002
043056391
TEVA ITALIA S.R.L.
IT
DE/H/3899/002
043056439
TEVA ITALIA S.R.L.
IT
DE/H/3899/002
043056441
TEVA ITALIA S.R.L.
IT
DE/H/3899/002
043056643
TEVA ITALIA S.R.L.
IT
DE/H/3899/002
043056528
TEVA ITALIA S.R.L.
IT
DE-H-3899-001002 DE/H/3899/001
90100.00.00
RATIOPHARM GMBH
DE
IS/1/16/056/01
RATIOPHARM GMBH
IS
DE/H/3899/002
90101.00.00
RATIOPHARM GMBH
DE
DE/H/3899/002
2015120202
RATIOPHARM GMBH
LU
DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/003 DE/H/1699/003 DE/H/1699/003 DE/H/1699/003 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002
028600029 028600031 028600043 028600029 028600031 028600043 28600070 28600082 28600070 28600082 028600017 028600056 028600068 028600017 028600056
TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA
IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
is authorised
ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA
S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A.
Page 11/21
Product Name (in authorisation country)
Lansox 30 mg capsule rigide Lansox 30 mg compresse orodispersibili Lansox 30 mg compresse orodispersibili Lansox 30 mg compresse orodispersibili Lansox 30 mg compresse orodispersibili Lanzo 15 mg munndreifitöflur Lanzo 15mg, munsönderfallande tabletter Lanzo 30 mg munndreifitöflur Lanzo 30 mg, munsönderfallande tabletter Lanzo Melt 15 mg smeltetabletter Lanzo Melt 30 mg smeltetabletter LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 15 MG, GELULE GASTRO-RESISTANTE LANZOR 30 MG, GELULES GASTRORESISTANTES LANZOR 30 MG, GELULES GASTRORESISTANTES LANZOR 30 MG, GELULES GASTRORESISTANTES LANZOR 30 MG, GELULES GASTRORESISTANTES LANZOR 30 MG, GELULES GASTRORESISTANTES LANZOR 30 MG, GELULES GASTRORESISTANTES
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/1699/002 DE/H/1699/004 DE/H/1699/004 DE/H/1699/004 DE/H/1699/004 IT/H/0226/003 IT/H/0226/003 IT/H/0226/004 IT/H/0226/004 IT/H/0226/003 IT/H/0226/004 not available not available not available not available not available not available not available not available not available not available not available
028600068 28600094 028600106 28600094 028600106 IS/1/02/131/01 17060 IS/1/02/131/02 17061 01-957 01-958 345 486-5 345 490-2 358 815-2 358 816-9 345 487-1 345 485-9 345 489-4 560 860-5 345 488-8 340 960-0 333 411-5
TAKEDA ITALIA S.P.A. TAKEDA ITALIA S.P.A. TAKEDA ITALIA S.P.A. TAKEDA ITALIA S.P.A. TAKEDA ITALIA S.P.A. PFIZER APS PFIZER AB PFIZER APS PFIZER AB PFIZER AS PFIZER AS SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE
IT IT IT IT IT IS SE IS SE NO NO FR FR FR FR FR FR FR FR FR FR FR
not available
558 545-9
SANOFI-AVENTIS FRANCE
FR
not available
344 756-9
SANOFI-AVENTIS FRANCE
FR
not available
343 035-6
SANOFI-AVENTIS FRANCE
FR
not available
344 755-2
SANOFI-AVENTIS FRANCE
FR
not available
343 033-3
SANOFI-AVENTIS FRANCE
FR
is authorised
Page 12/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
LIMPIDEX 15 mg capsule rigide
not available
028755027
LIMPIDEX 15 mg capsule rigide
not available
028755039
LIMPIDEX 15 mg capsule rigide
not available
028755041
LIMPIDEX 15 mg capsule rigide
not available
028755027
LIMPIDEX 15 mg capsule rigide
not available
028755039
LIMPIDEX 15 mg capsule rigide
not available
028755041
LIMPIDEX 15 mg compresse orodispersibili
not available
028755078
LIMPIDEX 15 mg compresse orodispersibili
not available
028755080
LIMPIDEX 15 mg compresse orodispersibili
not available
028755078
LIMPIDEX 15 mg compresse orodispersibili
not available
028755080
LIMPIDEX 30 mg capsule rigide
not available
028755015
LIMPIDEX 30 mg capsule rigide
not available
028755054
LIMPIDEX 30 mg capsule rigide
not available
028755066
LIMPIDEX 30 mg capsule rigide
not available
028755015
LIMPIDEX 30 mg capsule rigide
not available
028755054
LIMPIDEX 30 mg capsule rigide
not available
028755066
LIMPIDEX 30 mg compresse orodispersibili
not available
028755092
Product Name (in authorisation country)
EMA/727763/2017
is authorised SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE
S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A.
IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
Page 13/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
LIMPIDEX 30 mg compresse orodispersibili
not available
028755104
LIMPIDEX 30 mg compresse orodispersibili
not available
028755092
LIMPIDEX 30 mg compresse orodispersibili
not available
028755104
Monolitum Flas 15 mg comprimidos bucodispersables Monolitum Flas 30 mg comprimidos bucodispersables OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 15 mg, gélule gastro-résistante OGAST 30 mg, gélule gastro-résistante OGAST 30 mg, gélule gastro-résistante OGAST 30 mg, gélule gastro-résistante
not available
Product Name (in authorisation country)
EMA/727763/2017
is authorised IT
71367
SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A. LABORATORIOS SALVAT, S.A.
not available
71366
LABORATORIOS SALVAT, S.A.
ES
DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/001 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002
345 345 345 345 340 345 560 358 358 345 345 345 345 345 340 345 560 358 358 345 344 343 343
TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA TAKEDA
FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR
479-9 480-7 481-3 483-6 959-2 484-2 858-0 422-0 423-7 478-2 479-9 480-7 481-3 483-6 959-2 484-2 858-0 422-0 423-7 478-2 552-4 039-1 041-6
FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE
S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S. S.A.S.
IT IT ES
Page 14/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg, gélule gastro-résistante mg cápsulas gastrorresistentes
DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/002 DE/H/1699/001
333 412-1 558 546-5 344 551-8 344 552-4 343 039-1 343 041-6 333 412-1 558 546-5 344 551-8 3179496
Ogasto 15 mg cápsulas gastrorresistentes
DE/H/1699/001
3179595
Ogasto 15 mg cápsulas gastrorresistentes
DE/H/1699/001
3179694
Ogasto 15 mg cápsulas gastrorresistentes
DE/H/1699/001
3179496
Ogasto 15 mg cápsulas gastrorresistentes
DE/H/1699/001
3179595
Ogasto 15 mg cápsulas gastrorresistentes
DE/H/1699/001
3179694
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027488
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027587
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027686
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027488
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027587
Ogasto 15 mg comprimidos orodispersíveis
DE/H/1699/003
4027686
Product Name (in authorisation country)
OGAST OGAST OGAST OGAST OGAST OGAST OGAST OGAST OGAST Ogasto
30 30 30 30 30 30 30 30 30 15
EMA/727763/2017
is authorised TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA
FR FR FR FR FR FR FR FR FR PT PT PT PT PT PT PT PT PT PT PT PT
Page 15/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658599
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658698
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658797
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
3341898
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658599
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658698
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
2658797
Ogasto 30 mg cápsulas gastrorresistentes
DE/H/1699/002
3341898
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027785
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027884
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027983
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027785
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027884
Ogasto 30 mg comprimidos orodispersíveis
DE/H/1699/004
4027983
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
368 715-0 OU 34009 368 715 0 2 368 716-7 OU 34009 368 716 7 0 368 717-3 OU 34009 368 717 3 1
Product Name (in authorisation country)
EMA/727763/2017
is authorised LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA LUSOMEDICAMENTA – SOCIEDADE TÉCNICA FARMACÊUTICA, SA TAKEDA FRANCE S.A.S.
PT
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
PT PT PT PT PT PT PT PT PT PT PT PT PT FR
Page 16/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 15 mg, comprimé orodispersible
DE/H/1699/003
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
392 394-6 OU 34009 392 394 392 395-2 OU 34009 392 395 392 396-9 OU 34009 392 396 368 715-0 OU 34009 368 715 368 716-7 OU 34009 368 716 368 717-3 OU 34009 368 717 392 394-6 OU 34009 392 394 392 395-2 OU 34009 392 395 392 396-9 OU 34009 392 396 368 712-1 OU 34009 368 712 368 713-8 OU 34009 368 713 368 714-4 OU 34009 368 714 392 397-5 OU 34009 392 397 392 398-1 OU 34009 392 398 392 399-8 OU 34009 392 399 368 712-1 OU 34009 368 712 368 713-8 OU 34009 368 713
Product Name (in authorisation country)
EMA/727763/2017
is authorised 60 21 99 02 70 31 60 21 99 12 80 41 50 11 89 12 80
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
Page 17/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OGASTORO 30 mg, comprimé orodispersible
DE/H/1699/004
OPIREN 15 mg Cápsulas
DE/H/1699/001
368 714-4 OU 34009 368 714 392 397-5 OU 34009 392 397 392 398-1 OU 34009 392 398 392 399-8 OU 34009 392 399 61.448
OPIREN 15 mg Cápsulas
DE/H/1699/001
61.448
OPIREN 30 mg Cápsulas
DE/H/1699/002
59.785
OPIREN 30 mg Cápsulas
DE/H/1699/002
59.785
OPIREN FLAS 15 mg Comprimidos bucodispersables OPIREN FLAS 15 mg Comprimidos bucodispersables OPIREN FLAS 30 mg Comprimidos bucodispersables OPIREN FLAS 30 mg Comprimidos bucodispersables Pampe 15 mg cápsulas gastrorresistentes
DE/H/1699/003
65.474
DE/H/1699/003
65.474
DE/H/1699/004
65.475
DE/H/1699/004
65.475
not available
5017348
Pampe 15 mg, Cápsulas gastrorresistentes
not available
5017330
Prezal 15 mg, maagsapresistente capsule
DE/H/1699/001
RVG 18696
Prezal 15 mg, maagsapresistente capsule
DE/H/1699/001
RVG 18696
Prezal 15 mg, maagsapresistente capsule
DE/H/1699/001
RVG 18696
Product Name (in authorisation country)
EMA/727763/2017
is authorised 41 50 11 89
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FRANCE S.A.S.
FR
TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA FARMACÉUTICA ESPAÑA S.A LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. SANOFI-AVENTIS NETHERLANDS B.V. SANOFI-AVENTIS NETHERLANDS B.V. SANOFI-AVENTIS NETHERLANDS B.V.
ES ES ES ES ES ES ES ES PT PT NL NL NL
Page 18/21
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
Prezal 30 mg, maagsapresistente capsule
DE/H/1699/002
RVG 15420
Prezal 30 mg, maagsapresistente capsule
DE/H/1699/002
RVG 15420
Prezal 30 mg, maagsapresistente capsule
DE/H/1699/002
RVG 15420
Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan
DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001
043054218 043054232 043054269 043054220 043054271 043054081 043054093 043054283 043054055 043054321 043054257 043054042 043054295 043054131 043054129 043054117 043054028 043054067 043054079 043054319 043054156 043054168 043054170 043054182 043054194 043054016 043054206
Product Name (in authorisation country)
15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15
mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg
EMA/727763/2017
capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti Capsule rigide gastroresistenti
is authorised SANOFI-AVENTIS NETHERLANDS B.V. SANOFI-AVENTIS NETHERLANDS B.V. SANOFI-AVENTIS NETHERLANDS B.V. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. TEVA ITALIA S.R.L.
NL NL NL IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
Page 19/21
Product Name (in authorisation country)
Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan Tanzolan
15 15 15 15 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30
mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg mg
EMA/727763/2017
capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti Capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti capsule rigide gastroresistenti
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/001 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002 DE/H/3931/002
043054105 043054244 043054143 043054030 043054562 043054550 043054574 043054422 043054408 043054410 043054586 043054461 043054473 043054485 043054547 043054360 043054372 043054384 043054396 043054509 043054511 043054345 043054358 043054648 043054333 043054523 043054598 043054497 043054535 043054612 043054600 043054459 043054434
is authorised TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA TEVA
ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA ITALIA
S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L. S.R.L.
IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
Page 20/21
Product Name (in authorisation country)
Tanzolan 30 mg capsule rigide gastroresistenti Tanzolan 30 mg Capsule rigide gastroresistenti Zoton 15 mg compresse orodispersibili Zoton 15 mg compresse orodispersibili Zoton 30 mg compresse orodispersibili Zoton 30 mg compresse orodispersibili Zoton FasTab 15 mg oro-dispersible tablets Zoton FasTab 30 mg oro-dispersible tablets Zoton FasTab* 15 mg oro-dispersible tablets Zoton FasTab* 30 mg oro-dispersible tablets
EMA/727763/2017
MRP/DCP
National
MAH of product in the member
Member State
Authorisation
Authorisation
state
where product
number
Number
DE/H/3931/002 DE/H/3931/002 IT/H/0226/003 IT/H/0226/003 IT/H/0226/004 IT/H/0226/004 IT/H/0226/003 IT/H/0226/004 IT/H/0226/003 IT/H/0226/004
043054446 043054636 028775070 028775082 028775094 028775106 PA 0822/101/002 PA 0822/101/003 PL 00057/1296 PL 00057/1297
is authorised TEVA ITALIA S.R.L. TEVA ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L. PFIZER HEALTHCARE IRELAND PFIZER HEALTHCARE IRELAND PFIZER LIMITED PFIZER LIMITED
IT IT IT IT IT IT IE IE UK UK
Page 21/21
