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Document 52008XC1031(02)R(01)

Corrigendum to the Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2008 to 30 September 2008 ( OJ C 276, 31.10.2008 )

OJ C 330, 30.12.2008, p. 108–113 (EN)

30.12.2008   

EN

Official Journal of the European Union

C 330/108

Corrigendum to the Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2008 to 30 September 2008

( Official Journal of the European Union C 276 of 31 October 2008 )

(2008/C 330/10)

On page 25, in Annex II, all the entries from the first entry for Iceland to the end of the table shall be replaced by the following:

‘Iceland

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar-Comp 50/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Iceland

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar-Comp Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Iceland

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar-Comp 100/12,5 mg

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Ireland

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar” Comp 50 mg/12,5 mg film-coated tablets

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Ireland

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar” Comp 100 mg/25 mg film-coated tablets

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Merck Sharp & Dohme Italia S.p.A.

via G. Fabbroni, 6

I-00191 Rome

Hizaar 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Merck Sharp & Dohme Italia S.p.A.

via G. Fabbroni, 6

I-00191 Rome

Hizaar 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Merck Sharp & Dohme Italia S.p.A.

via G. Fabbroni, 6

I-00191 Rome

Forzaar 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Neopharmed S.p.A.

Via G. Fabbroni, 6

I-00191 Rome

Neo-Lotan Plus 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Neopharmed S.p.A.

Via G. Fabbroni, 6

I-00191 Rome

Neo-Lotan Plus 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

viale Shakespeare, 47

I-00144 Rome

Losazid 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

viale Shakespeare, 47

I-00144 Rome

Losazid 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Latvia

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Hyzaar 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Latvia

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Fortzaar 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lithuania

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Fortzaar (Losartan/Hydrochlorothiazide)

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lithuania

UAB Merck Sharp & Dohme, Geležinio Vilko 18A

LT-01112 Vilnius

HYZAAR (Losartan/Hydrochlorothiazide)

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

Merck Sharp & Dohme BV

Chaussée de Waterloo 1135

B-1180 Brussels

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Brussels

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Brussels

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Brussels

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

Merck Sharp & Dohme Ltd.

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Cozaar Comp “50/12,5” mg pilloli miksija b'rita

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

Merck Sharp & Dohme Ltd.

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar Comp” 100/12,5 mg pilloli miksija b'rita

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

Merck Sharp & Dohme Ltd.

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar Comp” 100/25 mg pilloli miksija b'rita

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar Plus 100/12,5

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Fortzaar 100/25

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Hyzaar 50/12,5

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

MSD BV

Waarderweg 39

2031 BN Haarlem

The Netherlands

Cozaar Comp

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

MSD BV

Waarderweg 39

2031 BN Haarlem

The Netherlands

Cozaar Comp

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

MSD BV

Waarderweg 39

2031 BN Haarlem

The Netherlands

Cozaar Comp Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Poland

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warsaw

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Poland

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warsaw

Hyzaar Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d' Arcos

Cozaar Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d' Arcos

Cozaar Plus

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d' Arcos

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Heptafarma-Companhia Farmacêutica, Sociedade Unipessoal, Lda

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Siaara

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Laboratório Medinfar

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Laboratório Medinfar

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan Plus

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

Frosst Portuguesa

Produtos Farmacêuticos, Lda.

Quinte da Fonte

Edificio Vasco da Gama, 19

P.O. Box 214

Porto Salvo

P-2780-730 Paço d'Arcos

Losartan + Hidroclorotiazida Frosst

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Romania

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, Etaj 3

Sector 1, Bucureşti

Romania

Hyzaar® 50 mg/12,5 mg, comprimate filmate

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Romania

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, Etaj 3

Sector 1, Bucureşti

Romania

Fortzaar® 100/25 mg, comprimate filmate

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

Merck Sharp & Dohme

inovativna zdravila d.o.o.

Smartinska cesta 140

SLO-1000 Ljubljana

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

Merck Sharp & Dohme

inovativna zdravila d.o.o.

Smartinska cesta 140

SLO-1000 Ljubljana

Hyzaar

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

Merck Sharp & Dohme

inovativna zdravila d.o.o.

Smartinska cesta 140

SLO-1000 Ljubljana

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Spain

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Spain

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar Comp 50 mg/12,5 mg filmdragerade tabletter

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar Comp 100 mg/12,5 mg filmdragerade tabletter

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

The Netherlands

Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 50/12,5 mg film-coated tablets

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 100/25 mg film-coated tablets

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 100 mg/12,5 mg film-coated tablets

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use’
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