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

dexlansoprazole, lansoprazole - European Medicines Agency

European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 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/ ...

282KB Sizes 0 Downloads 101 Views

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