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 )
Date: 2008-12-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market

CORRIGENDA

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

Iceland

Iceland

Ireland

Ireland

Italy

Italy

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Italia S.p.A.
via G. Fabbroni, 6
I-00191 Rome

Merck Sharp & Dohme Italia S.p.A.
via G. Fabbroni, 6
I-00191 Rome

Cozaar-Comp 50/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp Forte

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp 100/12,5 mg

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hizaar 100 mg + 25 mg
compresse rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

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Italy

Italy

Italy

Italy

Italy

Latvia

Latvia

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

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

Neopharmed S.p.A.
Via G. Fabbroni, 6
I-00191 Rome

Neopharmed S.p.A.
Via G. Fabbroni, 6
I-00191 Rome

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
viale Shakespeare, 47
I-00144 Rome

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
viale Shakespeare, 47
I-00144 Rome

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

SIA Merck Sharp & Dohme Latvia
Skanstes street 13
LV-1013 Riga

UAB Merck Sharp & Dohme
Geležinio Vilko 18A
LT-01112 Vilnius

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

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

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Losazid 100 mg + 25 mg
compresse rivestite con film

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar (Losartan/Hydrochloro-
thiazide)

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

UAB Merck Sharp & Dohme, Geležinio Vilko 18A
LT-01112 Vilnius

HYZAAR (Losartan/Hydrochloro-
thiazide)

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Merck Sharp & Dohme BV
Chaussée de Waterloo 1135
B-1180 Brussels

Merck Sharp & Dohme BV
Chaussée de Waterloo, 1135
B-1180 Brussels

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Brussels

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

.

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Luxembourg

Malta

Malta

Malta

The Netherlands

The Netherlands

The Netherlands

Norway

Norway

Norway

Therabel Pharma S.A.
Rue Egide Van Ophem, 108
B-1180 Brussels

Merck Sharp & Dohme Ltd.
Hertfordshire Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd.
Hertfordshire Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme Ltd.
Hertfordshire Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

MSD BV
Waarderweg 39
2031 BN Haarlem
The Netherlands

MSD BV
Waarderweg 39
2031 BN Haarlem
The Netherlands

MSD BV
Waarderweg 39
2031 BN Haarlem
The Netherlands

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Plus 100/12,5

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar 100/25

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar 50/12,5

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp

Cozaar Comp

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp Forte

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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Poland

Poland

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

MSD Polska Sp. z o.o.
ul. Chłodna 51
PL-00-867 Warsaw

MSD Polska Sp. z o.o.
ul. Chłodna 51
PL-00-867 Warsaw

Merck Sharp & Dohme, Lda.
Quinta da Fonte
Edifício Vasco da Gama, 19
Porto Salvo
P.O. Box 214
P-2770-192 Paço d' Arcos

Merck Sharp & Dohme, Lda.
Quinta da Fonte
Edifício Vasco da Gama, 19
Porto Salvo
P.O. Box 214
P-2770-192 Paço d' Arcos

Merck Sharp & Dohme, Lda.
Quinta da Fonte
Edifício Vasco da Gama, 19
Porto Salvo
P.O. Box 214
P-2770-192 Paço d' Arcos

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

Laboratório Medinfar
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

Laboratório Medinfar
Produtos Farmacêuticos, SA
Rua Manuel Ribeiro de Pavia, 1-1
Venda Nova
P-2700-547 Amadora

Hyzaar

Hyzaar Forte

Cozaar Plus

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Plus

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar

Siaara

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lortaan Plus

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lortaan Plus

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

.

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Portugal

Romania

Romania

Slovenia

Slovenia

Slovenia

Spain

Spain

Sweden

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

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, Nr. 1A
Clădirea C1, Etaj 3
Sector 1, Bucureşti
Romania

Merck Sharp & Dohme Romania S.R.L.
Bucharest Business Park
Şos. Bucureşti-Ploieşti, Nr. 1A
Clădirea C1, Etaj 3
Sector 1, Bucureşti
Romania

Merck Sharp & Dohme
inovativna zdravila d.o.o.
Smartinska cesta 140
SLO-1000 Ljubljana

Merck Sharp & Dohme
inovativna zdravila d.o.o.
Smartinska cesta 140
SLO-1000 Ljubljana

Merck Sharp & Dohme
inovativna zdravila d.o.o.
Smartinska cesta 140
SLO-1000 Ljubljana

Merck Sharp and Dohme de España, S.A.
C/ Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp and Dohme de España, S.A.
C/ Josefa Valcárcel, 38
E-28027 Madrid

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Losartan + Hidroclorotiazida Frosst

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar® 50 mg/12,5 mg, compri-
mate filmate

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Fortzaar® 100/25 mg, comprimate
filmate

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hyzaar

Hyzaar

Fortzaar

Cozaar Plus

Fortzaar

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp 50 mg/12,5 mg
filmdragerade tabletter

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

C

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Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme
PO Box 581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

Cozaar Comp 100 mg/12,5 mg
filmdragerade tabletter

100 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar Comp Forte 100 mg/25 mg
filmdragerade tabletter

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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

50 mg losartan potassium —
12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cozaar-Comp 100/25 mg
film-coated tablets

100 mg losartan potassium —
25 mg hydrochlorothiazide

Film-coated tablet

Oral use

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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