natgillin/translations-raw huggingface dataset:
Cozaar Comp 50 mg/ 12.5 mg > contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 50 mg/ 12, 5 mg tablett sisaldab toimeainetena 50 mg losartaankaaliumi ja 12, 5 mg hüdroklorotiasiidi.
Cozaar Comp100 mg/ 12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/ 12, 5 mg tablett sisaldab toimeainetena 100 mg losartaankaaliumi ja 12, 5 mg hüdroklorotiasiidi.
Cozaar Comp 100 mg/ 25 mg > contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 50 mg/ 25 mg tablett sisaldab toimeainetena 100 mg losartaankaaliumi ja 25 mg hüdroklorotiasiidi.
Cozaar Comp 50 mg/ 12.5 mg, Cozaar Comp 100 mg/ 12.5 mgand Cozaar Comp 100 mg/ 25 mg contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.
Cozaar Comp 50 mg/ 12, 5 mg, Cozaar Comp 100 mg/ 12, 5 mg ja Cozaar Comp 100 mg/ 25 mg sisaldavad järgmisi abiaineid: mikrokristalne tselluloos, laktoosmonohüdraat, modifitseeritud maisitärklis, magneesiumstearaat, hüdroksüpropüültselluloos, hüpromelloos.
Cozaar Comp 100 mg/ 12.5 mg mg and Cozaar Comp 100 mg/ 25 mg contain 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 100 mg/ 12, 5 mg mg ja Cozaar Comp 100 mg/ 25 mg sisaldavad 8, 48 mg (0, 216 mEq) kaaliumi.
Cozaar Comp 50 mg/ 12.5 mg and Cozaar Comp 100 mg/ 25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp 50 mg/ 12, 5 mg ja Cozaar Comp 100 mg/ 25 mg sisaldavad ka titaandioksiidi (E171), kinoliinkollase alumiiniumlakki (E104) ja karnaubavaha (E903).
Cozaar Comp 100 mg/ 12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
Karnaubavaha (E903), titaandioksiid (E171)
What Cozaar Comp looks like and contents of the pack
Kuidas Cozaar Comp välja näeb ja pakendi sisu
Cozaar Comp 50 mg/ 12.5 mg is supplied as scored or unscored film-coated tablets.
Cozaar Comp 50 mg/ 12, 5 mg on poolitusjoonega või poolitusjooneta õhukese polümeerikattega tabletid.
Cozaar Comp 100 mg/ 12.5 mg mg is supplied as unscored film-coated tablets.
Cozaar Comp 100 mg/ 12, 5 mg on poolitusjooneta õhukese polümeerikattega tabletid.
Cozaar Comp 100 mg/ 25 mg is supplied as unscored film-coated tablets.
Cozaar Comp 100 mg/ 25 mg on poolitusjooneta õhukese polümeerikattega tabletid.
62 Cozaar Comp 50 mg/ 12.5 mg > - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
66 Cozaar Comp 50 mg/ 12, 5 mg - alumiiniumfooliumiga suletud PVC/ PE/ PVDC blisterpakendid, 4, 7, 10, 14, 20, 28, 30, 50, 56, 98 või 280 tabletti pakendis.
Cozaar Comp 100 mg/ 25 mg - PVC/ PE/ PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Cozaar Comp 100 mg/ 25 mg - alumiiniumfooliumiga suletud PVC/ PE/ PVDC blisterpakendid, 4, 7, 10, 14, 20, 28, 30, 50, 56, 98 või 280 tabletti pakendis.
< To be completed nationally >
< Täidetakse riiklikul tasemel >
Austria Austria Belgium Belgium Belgium Belgium Bulgaria Cyprus Cyprus Denmark Denmark Denmark Denmark Estonia
Austria Austria Belgia Belgia Belgia Belgia Bulgaaria Küpros Küpros Taani Taani Taani Taani Eesti
Cosaar Plus - Filmtabletten Fortzaar-Filmtabletten COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12,5 MG LOORTAN PLUS FORTE 100 MG/ 25 MG LOORTAN PLUS 50 MG/ 12,5 MG Hyzaar FORTZAAR HYZAAR Cozaar Comp.
Cosaar Plus - Filmtabletten Fortzaar- Filmtabletten COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12, 5MG LOORTAN PLUS FORTE 100MG/ 25MG LOORTAN PLUS 50 MG/ 12, 5MG Hyzaar FORTZAAR HYZAAR Cozaar Comp.
100 mg / 12,5 mg Fortzaar HYZAAR
100 mg / 12, 5 mg Fortzaar HYZAAR
Estonia Finland Finland France
Eesti Soome Soome Prantsusmaa
FORTZAAR Cozaar Comp Cozaar Comp Forte Fortzaar 100 mg/ 25 mg film-coated tablets
FORTZAAR Cozaar Comp Cozaar Comp Forte Fortzaar 100 mg/ 25 mg film- coated tablets
Fortzaar 50 mg/ 12,5 mg film-coated tablets
Fortzaar 50 mg/ 12, 5 mg film- coated tablets
Fortzaar 100 mg/ 12,5 mg film-coated tablets
Fortzaar 100 mg/ 12, 5 mg film- coated tablets
Germany Germany Germany Germany Germany Germany Greece
Saksamaa Saksamaa Saksamaa Saksamaa Saksamaa Saksamaa
LORZAAR PLUS 50/ 12,5 mg Filmtabletten CARDOPAL PLUS 50/ 12,5 mg Filmtabletten LORZAAR VARIPHARM PLUS 50/ 12,5 mg Filmtabletten FORTZAAR 100/ 25 mg Filmtabletten FORTZAAR VARIPHARM 100/ 25 mg Filmtabletten LORZAAR PLUS forte 100/ 12,5 mg Filmtabletten HYZAAR
LORZAAR PLUS 50/ 12, 5 mg Filmtabletten CARDOPAL PLUS 50/ 12, 5 mg Filmtabletten LORZAAR VARIPHARM PLUS 50/ 12, 5 mg Filmtabletten FORTZAAR 100/ 25 mg Filmtabletten FORTZAAR VARIPHARM 100/ 25mg Filmtabletten LORZAAR PLUS forte 100/ 12, 5mg Filmtabletten
63 Greece Hungary
67 Saksamaa Greece Greece Ungari Ungari Iirimaa Iirimaa
HYZAAR 100/ 25 Hyzaar 50/ 12.5 mg
HYZAAR HYZAAR HYZAAR 100/ 25 Hyzaar 50/ 12. 5 mg Hyzaar Forte 100/ 25 mg ‘ Cozaar ’ Comp 50 mg/ 12. 5 mg film- coated tablets Cozaar ’ Comp 100 mg/ 25 mg film- coated tablets
Hungary Ireland Ireland
Itaalia Itaalia
Italy HIZAAR 50 mg + 12,5 mg compresse rivestite con film Italy HIZAAR 100 mg + 25 mg compresse rivestite con film
HIZAAR 50 mg + 12, 5 mg compresse rivestite con film HIZAAR 100 mg + 25 mg compresse rivestite con film
Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Malta
Itaalia Itaalia Itaalia Itaalia Itaalia Läti Läti Leedu
HYZAAR (Losartan/ Hydrochlorothiazide) COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12,5 MG LOORTAN PLUS FORTE 100 mg/ 25 mg LOORTAN PLUS 50 mg/ 12,5 mg "Cozaar Comp" 50/ 12.5 mg pilloli miksija b’ rita
FORZAAR 100 mg + 25 mg compresse rivestite con film NEO- LOTAN PLUS 50 mg + 12, 5 mg compresse rivestite con film NEO- LOTAN PLUS 100 mg + 25 mg compresse rivestite con film LOSAZID 50 mg + 12, 5 mg compresse rivestite con film LOSAZID 100 mg + 25 mg compresse rivestite con film HYZAAR 50 mg/ 12, 5 mg; Fortzaar 100 mg/ 25 mg FORTZAAR (Losartan/ Hydrochlorothiazide)
Netherlands Netherlands Netherlands Poland Poland Portugal Portugal Portugal Portugal Portugal Romania Romania Slovenia Slovenia Spain Spain Sweden Sweden
Leedu Luksemburg Luksemburg Luksemburg Luksemburg Malta Malta Malta Holland Holland Holland Poola Poola Portugal Portugal Portugal Portugal Portugal Rumeenia Rumeenia Sloveenia Sloveenia Hispaania Hispaania Rootsi Rootsi Rootsi Suurbritannia Suurbritannia Suurbritannia
Cozaar Plus 100/ 12,5 Fortzaar 100/ 25 Hyzaar 50/ 12,5 HYZAAR HYZAAR FORTE COZAAR Plus FORTZAAR SIAARA LORTAAN Plus Losartan + Hidroclorotiazida Frosst HYZAAR® 50 mg/ 12,5 mg, comprimate filmate FORTZAAR® 100/ 25 mg,, comprimate filmate HYZAAR FORTZAAR Cozaar Plus Fortzaar Cozaar Comp 50 mg/ 12,5 mg filmdragerade tabletter Cozaar Comp 100 mg/ 12,5 mg filmdragerade tabletter
HYZAAR (Losartan/ Hydrochlorothiazide) COZAAR PLUS FORTE 100 MG/ 25 MG COZAAR PLUS 50 MG/ 12, 5 MG LOORTAN PLUS FORTE 100 mg/ 25 mg LOORTAN PLUS 50 mg/ 12, 5 mg "Cozaar Comp" 50/ 12. 5 mg pilloli miksija b’ rita "Cozaar Comp" 100/ 25 mgpilloli miksija b’ rita" Cozaar Comp "100/ 12, 5 mgpilloli miksija b’ rita Cozaar Plus 100/ 12, 5 Fortzaar 100/ 25 Hyzaar 50/ 12, 5 HYZAAR HYZAAR FORTE COZAAR Plus FORTZAAR SIAARA LORTAAN Plus Losartan + Hidroclorotiazida Frosst HYZAAR® 50 mg/ 12, 5 mg, comprimate filmate FORTZAAR® 100 / 25 mg,, comprimate filmate HYZAAR FORTZAAR Cozaar Plus Fortzaar Cozaar Comp 50 mg/ 12, 5 mg filmdragerade tabletter Cozaar Comp 100 mg/ 12, 5 mg filmdragerade tabletter Cozaar Comp Forte 100 mg/ 25 mg filmdragerade tabletter COZAAR- COMP 50/ 12. 5 MG FILM COATED TABLETS COZAAR- COMP 100/ 25 MG FILM COATED TABLETS COZAAR- Comp100 mg/ 12. 5 mg Film- coated tablets
64 Sweden United Kingdom United Kingdom United Kingdom
68
Iceland Iceland Iceland Norway Norway
Island Island Island Norra Norra
COZAAR-COMP 50/ 12.5MG COZAAR-COMP Forte COZAAR-COMP 100/ 12.5MG Cozaar Comp Cozaar Comp Forte
COZAAR- COMP 50/ 12. 5 MG COZAAR- COMP Forte COZAAR- COMP 100/ 12. 5 MG Cozaar Comp Cozaar Comp Forte
65
69
Ref.
London, 3. september 2008 Viide:
EMEA/ CHMP/ 494914/ 2008
EMEA/ CHMP/ 494921/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names
ARVAMUS PÄRAST ARTIKLI 30 KOHAST ESILDIST, MIS KÄSITLES RAVIMIT Cozaar Comp ja sarnased nimetused
International Non-Proprietary Name (INN): losartan + hydrochlorothiazide
Rahvusvaheline mittekaubanduslik nimetus (INN): losartaan + hüdroklorotiasiid
Cozaar Comp and associated names, 50/ 12.5 mg; 100/ 12.5 mg; 100/ 25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.
Cozaar Comp ja sarnased nimetused (50/ 12, 5 mg, 100/ 12, 5 mg ja 100/ 25 mg) on losartaani ja hüdroklorotiasiidi fikseeritud annuse kombinatsiooni sisaldavad õhukese polümeerikattega tabletid.
The losartan/ hydrochlorothiazide combination is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Losartaani ja hüdroklorotiasiidi kombinatsioon on näidustatud hüpertensiooni raviks patsientidel, kellel kas ainult losartaani või hüdroklorotiasiidiga ei saavutata küllaldast vererõhu langust.
On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar Comp. and associated names.
23. veebruaril 2007 esitas Taani Euroopa Ravimiametile muudetud direktiivi 2001/ 83/ EÜ artikli 30 alusel esildise, et ühtlustada ravimi Cozaar Comp ja sarnaste nimetuste ravimi omaduste kokkuvõtted, pakendi infolehed ja märgistus.
Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide; As first step treatment in patients with moderate to severe hypertension and in patients with high or very high cardiovascular risk; Reduction of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Esildise aluseks olid ravimi Cozaar Comp ja sarnaste nimetuste Euroopa Liidu liikmesriikides heakskiidetud ravimi omaduste kokkuvõtete erinevused seoses järgmiste näidustustega: hüpertensiooni ravi patsientidel, kellel ainult losartaani või hüdroklorotiasiidiga ei ole saavutatud küllaldast vererõhu langust; mõõduka kuni raske hüpertensiooniga patsientide ja suure või väga suure südameveresoonkonna riskiga patsientide esmavaliku ravi; südameveresoonkonna haigestumise ja suremuse vähendamine hüpertensiooniga patsientidel, kellel on vasaku vatsakese hüpertroofia.
During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
21. – 24. aprilli 2008 koosolekul oli inimravimikomitee, võttes arvesse esitatud kokkuvõtlikke andmeid ja komiteesisest teaduslikku arutelu, arvamusel, et ravimi omaduste kokkuvõtete, märgistuse ja pakendi infolehtede ühtlustamise ettepanek on vastuvõetav ning need dokumendid tuleb muuta.
The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Asjaomased raviminimetused on esitatud I lisas, teaduslikud järeldused II lisas ning muudetud ravimi omaduste kokkuvõte, märgistus ja pakendi infoleht III lisas.
Merck Sharp & Dohme GmbH Donau-City-Straße 6 1220 Wien Austria
Merck Sharp &
Cosaar 12,5 mg - Filmtabletten
Cosaar
12.5 mg
12, 5 mg - 12, 5 mg
Film-coated tablet
Õhukese polümeerikattega tabletid suukaudne
Oral use
Filmtabletten
Merck Sharp & Dohme GmbH Donau-City-Straße 6 1220 Wien Austria
Merck Sharp & Dohme GmbH Donau- City- Straße 6, 1220 Viin, Austria
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Brüssel, Belgia
COZAAR 12,5 mg
COZAAR 12, 5 mg
12.5 mg
12, 5 mg
21 x 12.5 mg + 14 x 50 mg
21 X 12, 5 MG + 14 X 50 MG
Marketing Authorisation Holder
Õhukese polümeerikattega tabletid suukaudne
Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brüssel, Belgia
100 mg
100 mg 2
LOORTAN 12,5 mg
LOORTAN
12.5 mg
12, 50 mg 12, 5 mg
LOORTAN CARDIO START
LOORTAN START
21 x 12.5 mg + 14 x 50 mg
CARDIO 21 X 12, 5 MG + 14 X 50 MG
1407 Sofia Bulgaria
1407 Sofia, Bulgaaria
Oral use
Küpros
50 mg
50 MG
100 mg
100 MG
Filmcoated tablet
Õhukese polümeerikattega tabletid suukaudne
Denmark
3 Taani
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem Holland
Cozaar Startpakke
Startpakke
12.5 mg + 50 mg
12, 5 mg + 50 mg
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn, Eesti
Cozaar 12,5 mg
Cozaar
Film-coated tablet
12, 5 mg
Oral use
Õhukese polümeerikattega tabletid suukaudne
Waarderweg 39 P. O. Box 581 2003 PC HAARLEM the Netherlands
Waarderweg 39 P. O. Box 581 2003 PC HAARLEM Holland
12.5 mg
12. 5 mg
12.5 mg + 50 mg
12. 5 mg and 50 mg (initiation pack)
Finland
4 Soome
Hoche 75114 Paris Cedex 08 France
Hoche 75114 Paris Cedex 08, Prantsusmaa
Cozaar 100 mg film-coated tablets
100 mg film - tablets
Cozaar 50 mg scored coated tablets
50 mg scored tablets
Scored coated tablet
Õhukese polümeerikattega tabletid suukaudne
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
MSD Chibropharm GmbH Postfach 1202 D- 85530 Haar, Saksamaa
CARDOPAL START 12,5 mg Filmtabletten
CARDOPAL START 12, 5 mg 12, 5 mg Filmtabletten
12.5 mg
Saksamaa
Film-coated tablet
LORZAAR 100 mg 100 mg Filmtabletten
LORZAAR 100 mg Filmtabletten
LORZAAR 50 mg 50 mg Filmtabletten
100 mg
Saksamaa
Film-coated tablet
MSD Chibropharm GmbH Postfach 1202 D- 85530 Haar, Saksamaa
Oral use
LORZAAR 100 mg PROTECT 100 mg Filmtabletten
5 Member State
5
Strength
Saksamaa
LORZAAR 50 mg Filmtabletten
LORZAAR PROTECT 50 mg Filmtabletten
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
MSD Chibropharm
LORZAAR PROTECT Filmtabletten
LORZAAR START
100 mg 100 mg
12, 5 mg
MSD Chibropharm GmbH Postfach 1202 D-85530 Haar Germany
GmbH Postfach 1202 D- 85530 Haar, Saksamaa
50 mg 50 mg
12, 5 mg
Film-coated tablet
Filmtabletten
Germany
PINZAAR
PINZAAR 100 mg Filmtabletten 100 mg
100 mg 100 mg
Film-coated tablet
GmbH Postfach 1202 D- 85530 Haar, Saksamaa
PINZAAR 50 mg Filmtabletten 50 mg
PINZAAR 50 mg 50 mg Filmtabletten
VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 85540, Haar, Germany
VARIPHARM ARZNEIMITTEL GmbH Lindenplatz 1 85540, Haar, Saksamaa
LORZAAR 12.5 mg VARIPHARMSTART 12,5 mg Filmtabletten
LORZAAR 12, 5 mg VARIPHARMSTART 12, 5 mg Filmtabletten
COZAAR 12.5 mg
COZAAR 12. 5 mg
COZAAR 50 mg
COZAAR 50 mg
Film-coated tablet
H- 1123 Budapest, Ungari
Oral use
Cozaar 12, 5 mg
6 Member State
6
Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Õhukese polümeerikattega tabletid suukaudne
12.5 mg
Ungari
Cozaar
Ungari
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Hoddesdon, EN11 9BU, Ühendkuningriik
COZAAR 50 mg Film-coated Tablets
COZAAR 50 mg Film - 50 mg coated Tablets
Strength
Iirimaa
Route of administration
Merck Sharp & Dohme Limited Hertford Hoddesdon, EN11 Ühendkuningriik
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Road, Herts 9BU,
COZAAR 100 mg Film-coated 100 mg Tablets
COZAAR 100 mg 100 mg Film- coated Tablets
Oral use
Iirimaa
Ireland
Merck Sharp & Dohme Limited Hertford Hoddesdon, EN11 Ühendkuningriik
COZAAR 12.5mg Film-coated 12.5mg Tablets
COZAAR 12. 5 mg 12. 5 mg Film- coated Tablets
Via G.
Merck Sharp &
LORTAAN 50 mg compresse 50 mg rivestite con film
LORTAAN 50 mg 50 mg
Merck Sharp & Dohme (Italia) S. p. A.
Dohme (Italia) S. p. A. compresse rivestite con
Fabbroni 6, 00191 Rome, Italy
Fabbroni 6, 00191 Rooma, Itaalia
LORTAAN 12,5 mg compresse 12.5 mg rivestite con film
film
Film-coated tablet
Itaalia
Oral use
Merck Sharp &
Italy
LORTAAN 12, 5 mg 12. 5 mg
LORTAAN 100 mg compresse 100 mg rivestite con film
100 mg 100 mg
Oral use
Via G.
NEO-LOTAN 50 mg compresse 50 mg rivestite con film
NEO- LOTAN 50 mg 50 mg compresse rivestite con film
NEO-LOTAN 12,5 mg 12.5 mg compresse rivestite con film
NEO- LOTAN 12, 5 mg 12. 5 mg compresse rivestite con film
NEO-LOTAN 100 mg 100 mg compresse rivestite con film
NEO- LOTAN 100 mg 100 mg compresse rivestite con film
Sigma-Tau Industrie Farmaceutiche LOSAPREX 50 mg compresse 50 mg Riunite S. p. A. - Viale Shakespeare rivestite con film 47, 00144 Rome Italy
Sigma- Tau Industrie LOSAPREX
Oral use
50 mg 50 mg
Route of administration
Farmaceutiche Riunite compresse rivestite con
Sigma-Tau Industrie Farmaceutiche Riunite S. p. A. - Viale Shakespeare 47, 00144 Rome Italy
S. p. A. - Viale Shakespeare 47, 00144 Rooma, Itaalia
mg
film
Sigma-Tau Industrie Farmaceutiche Riunite S. p. A. - Viale Shakespeare 47, 00144 Rome Italy
Sigma- Tau Industrie LOSAPREX 12, 5 mg 12. 5 mg Farmaceutiche Riunite compresse rivestite con S. p. A. - Viale film Shakespeare 47, 00144 Rooma, Itaalia
LOSAPREX 100 mg compresse 100 mg rivestite con film
Sigma- Tau Industrie LOSAPREX 100 mg 100 mg Farmaceutiche Riunite compresse rivestite con S. p. A. - Viale film Shakespeare 47, 00144 Rooma, Itaalia
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga Latvia
SIA Merck Sharp & Cozaar 50 mg film - 50 mg Dohme Latvia, Latvija; coated tablets Skanstes street 13, LV - 1013, Riia, Läti
Cozaar 50 mg film-coated 50 mg tablets
Õhukese polümeerikattega tabletid suukaudne
Oral use
8 Läti
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga Latvia
SIA Merck Sharp &
Cozaar 100 mg film-coated 100 mg tablets
100 mg film - 100 mg
Oral use
Dohme Latvia, Latvija; coated tablets Skanstes street 13, LV - 1013, Riia, Läti Leedu
UAB Merck Sharp & Dohme, Gelež inio Vilko 18A, LT- 01112 Vilnius Lithuania
UAB Merck Sharp & Cozaar Dohme, Geležinio (Losartan) Vilko 18A, LT - 01112 Vilnius, Leedu
Cozaar 12.5 mg (Losartan)
12, 5 mg
oral use
Leedu
Cozaar 50 mg (Losartan)
50 mg
Cozaar 100 mg (Losartan)
100 mg
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & COZAAR 100 mg Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Brüssel, Belgia
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & COZAAR 50 MG Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Brüssel, Belgia
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & COZAAR 12, 5 mg Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Brüssel, Belgia
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & COZAAR CARDIO Dohme BV - Chaussée START de Waterloo 1135 - B - 1180 Brüssel, Belgia
Luxembourg
9 Luksemburg
Therabel Pharma S. A. - Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brüssel, Belgia
LOORTAN
LOORTAN
12,50 mg
12, 50 mg 12, 5 mg
Invented name
Luksemburg
Luxembourg Therabel Pharma S. A. - Rue Egide Van Ophem 108 B-1180 Brussels Belgium
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brüssel, Belgia
Oral use
Malta
Malta Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Ühendkuningriik
"Cozaar 100 mg" pilloli miksija b’ rita
"Cozaar pilloli
100mg
100 mg "100 mg miksija b’ rita
"Cozaar 50 mg" pilloli miksija b’ rita
"Cozaar pilloli
50mg
50 mg "50 mg miksija b’ rita
The Merck Sharp & Dohme Netherlands PO Box 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Holland
50 mg
10
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Õhukese polümeerikattega tabletid suukaudne
100 mg
Poola
Chł odna 51 00-867 Warsaw Poland
COZAAR Chłodna 51 00- 867 Varssavi, Poola
Merck Sharp & Dohme, Lda.
Merck Sharp & COZAAR Dohme, Lda.
Merck Sharp & Dohme, Lda.
Merck Sharp & COZAAR 100 mg Dohme, Lda.
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora Portugal
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1- 1° Venda Nova 2700- 547 Amadora, Portugal
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora Portugal
LABORATÓRIO
LORTAAN IC- Titulação
LORTAAN IC -
Oral use
MEDINFAR, Produtos Titulação Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1- 1° Venda Nova 2700- 547 Amadora, Portugal
LORTAAN 100mg
LORTAAN
Film-coated tablet
100 mg
Bucureş ti-Ploieş ti, Nr.
Bucureşti- Ploieşti, Nr.
1A, Clă direa C1, Etaj 3 Sector 1, Bucureş ti Romania
1A, Clădirea C1, Etaj 3 Sector 1, Bukarest, Rumeenia
COZAAR, comprimate filmate, 50 mg 50 mg
COZAAR, comprimate 50 mg filmate, 50 mg
Merck Sharp & Dohme, inovativna zdravila d. o. o., Š martinska cesta 140, 1000 Ljubljana Slovenia
Merck Sharp & Dohme, inovativna zdravila d. o. o., Šmartinska cesta 140, 1000 Ljubljana, Sloveenia
Cozaar 12,5 mg filmsko 12.5 mg oblož ene tablete
Cozaar 12, 5 mg 12, 5 mg filmsko obložene tablete
Cozaar 50 mg filmsko oblož ene 50 mg tablete
Cozaar 50 mg filmsko 50 mg obložene tablete
Film-coated tablet
13
Cozaar 100 mg filmsko 100 mg oblož ene tablete
Cozaar 100 mg 100 mg filmsko obložene tablete
C/ Josefa Valcárcel, 38 28027 Madrid Spain
C / Josefa Valcárcel, 38 28027 MADRIID, Hispaania
Cozaar 12.5 mg Inicio 12.5 mg
Cozaar 12, 5 mg Inicio 12, 5 mg
Strength
Hispaania
Cozaar 50 mg
Cozaar 50 mg 50 mg
Cozaar 100 mg
Cozaar 100 mg 100 mg
100 mg
Rootsi
Film-coated tablet
Merck Sharp &
Oral use
Cozaar
Sweden
12, 5 mg 12, 5 mg
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Dohme PO Box 581 2003 PC Haarlem Holland
Cozaar 12,5 mg filmdragerade tabletter
filmdragerade tabletter
Cozaar 12,5 mg + 50 mg filmdragerade tabletter
Cozaar 12, 5 mg + 12, 5 + 50 mg 50 mg filmdragerade tabletter
12.5 mg + 50 mg
14 Rootsi
Sweden
50 mg 50 mg
Cozaar 50 mg filmdragerade tabletter
filmdragerade tabletter
Cozaar 100 mg filmdragerade tabletter
Cozaar 100 mg 100 mg filmdragerade tabletter
100 mg
Ühendkuningriik
Film-coated tablet
COZAAR 50 MG 50 MG FILM- COATED TABLETS
Oral use
Ühendkuningriik
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Ühendkuningriik
COZAAR 50 mg film-coated tablets
COZAAR 100 MG 100 MG FILM- COATED TABLETS
50 mg
Cozaar 50 mg
15 Member State
15
Invented name
Island
Strength
Cozaar
Pharmaceutical Form
100 mg
Route of administration
Õhukese polümeerikattega tabletid suukaudne
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU United Kingdom
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Holland
COZAAR 25 mg film-coated tablets
Cozaar
25 mg
12, 5 mg
Oral use
Norra
United Kingdom
Cozaar
COZAAR 100 mg film-coated tablets
Cozaar
16 ANNEX II
16 II LISA
17 SCIENTIFIC CONCLUSIONS
17 TEADUSLIKUD JÄRELDUSED
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR AND ASSOCIATED NAMES (SEE ANNEX I)
COZAAR COMP. - i JA SARNASTE NIMETUSTE (VT I LISA) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
Cozaar (losartan) was included in the list of products for Product Information harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of the Directive 2001/ 83/ EC in order to resolve divergences amongst the nationally authorised SPCs and therefore to harmonise these divergent SPCs across the European Union.
Cozaar Comp. ja Cozaar Comp Forte (losartaan/ hüdroklorotiasiid) on lisatud ravimi omaduste kokkuvõtete ühtlustamisele kuuluvate ravimite nimekirja, mille koostas inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühm kooskõlas muudetud direktiivi 2001/ 83/ EÜ artikli 30 lõikega 2.
Losartan is indicated for the treatment of hypertension.
Hüdroklorotiasiid on tiasiid- diureetikum, mida kasutatakse ka antihüpertensiivse ravimina.