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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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