natgillin/translations-raw huggingface dataset:
23 EMEA 2005 Dosisjustering ved nedsat leverfunktion Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se afsnit 4. 4 “ Særlige advarsler og forsigtighedsregler vedrørende brugen ” og 5. 2 ” Farmakokinetiske egenskaber ”).
No dosage adjustment is necessary in patients with hepatic impairment (see sections 4.4 “ Special warnings and special precautions for use” and 5.2 “ Pharmacokinetic properties”) 22  EMEA 2005 Paediatric use:
24 EMEA 2005 Hos nogle patienter med bilateral nyrearteriestenose eller stenose af arterien til en solitær nyre er der set øgning i mængden af urinstof i blodet og forhøjelse af serumkreatinin ved behandling med ACE - hæmmere.
In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, who have been treated with ACE inhibitors, increases in blood urea and serum creatinine, usually reversible 23  EMEA 2005 upon discontinuation of therapy, have been seen.
Patienter, der modtager ACE- hæmmerbehandling, og som udvikler
Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up (see 4.8 Undesirable effects).
25 EMEA 2005 ikterus eller markante forhøjelser af leverenzymer, skal seponere ACE- hæmmerbehandlingen og modtage passende medicinsk opfølgning (4. 8 Bivirkninger).
24  EMEA 2005 Neutropenia/ Agranulocytosis/ Thrombocytopenia/ Anaemia:
Neutropeni/ agranulocytose/ trombocytopeni/ anæmi Der er rapporteret neutropeni/ agranulocytose, trombocytopeni og anæmi hos patienter i ACE - hæmmerbehandling.
Neutropenia/ agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors.
26 EMEA 2005 Graviditet og amning (Se afsnit 4. 3 ” Kontraindikationer ” og afsnit 4. 6 ” Graviditet og amning ”).
(See section 4.3 “ Contraindications” and section 4.6 “ Pregnancy and lactation”).
4. 5 Interaktion med andre lægemidler og andre former for interaktion
25  EMEA 2005 4.5 Interaction with other medicinal products and other forms of interaction
27 EMEA 2005 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
Kontrollerede studier med ACE- hæmmere er ikke gennemført på mennesker, men i et begrænset antal tilfælde af brug i første trimester synes der ikke at have været nogen misdannelser, der kan forenes med human fosterforgiftning som beskrevet nedenfor.
Controlled studies with ACE inhibitors have not been done in humans, but in a 26  EMEA 2005 limited number of cases with first trimester exposure there do not appear to have been any malformations consistent with human foetotoxicity as described below.
Såfremt der er sket brug af perindopril fra andet trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet.
Lactation:
Almindelige: kvalme, opkastninger, mavesmerter, dysgeusi, dyspepsi, diarré, forstoppelse 28 EMEA 2005 Ualmindelige: tør mund Meget sjældne: pancreatitis
Common: nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea, constipation Uncommon: dry mouth Very rare: pancreatitis
Lever- galde- forstyrrelser:
Hepato-biliary disorders:
Hud - og subkutane vævsforstyrrelser:
27  EMEA 2005 Skin and subcutaneous tissue disorders:
(Se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen, Hæmodialysepatienter.) Pacemaker- behandling er indiceret ved 29 EMEA 2005 behandlingsresistent bradycardia.
(See 4.4 Special warnings and special precautions for use, Haemodialysis Patients.) Pacemaker therapy is indicated for therapy-resistant bradycardia.
5.
28  EMEA 2005 5.
30 EMEA 2005 Forsøgspopulationen havde evidens for koronararteriesygdom uden kliniske tegn på hjertesvigt. Generelt havde 90% af patienterne tidligere haft et myokardieinfarkt og/ eller gennemgået koronar revaskularisering.
Overall, 90% of the patients had a previous myocardial infarction and/ or a previous coronary revascularisation.
Det væsentligste effektmål omfattede kardiovaskulær mortalitet, non- fatal myokardieinfarkt og/ eller hjertestop med vellykket genoplivning.
The main efficacy criterion was the composite of cardiovascular mortality, non fatal myocardial infarction and/ or cardiac arrest with successful resuscitation.
Behandlingen med perindopril 8 mg en gang daglig resulterede i en signifikant absolut reduktion i det primære endepunkt på 1, 9% (relativ risikoreduktion på 20% (95% CI [9, 4; 28, 6] – p < 0, 001).
The treatment with perindopril 8 mg once 29  EMEA 2005 daily resulted in a significant absolute reduction in the primary endpoint of 1.9% (relative risk reduction of 20%, 95%CI [9.4; 28.6] – p < 0.001).
31 EMEA 2005 6. 2 Uforligeligheder
6.2 Incompatibilities
< [Udfyldes nationalt] >
< [To be completed nationally] > 30  EMEA 2005 6.4 Special precautions for storage
6. 5 Emballage (art og indhold)
6.6 Nature and contents of container
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Særnavn Losartankalium og hydrochlorthiazid
Invented name
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Bruxelles Belgien
Merck Sharp & Dohme GmbH Donau-City-Straße 6 1220 Wien Austria
COZAAR PLUS FORTE 100 MG/ 25 MG
Cosaar Plus - Filmtabletten
100 mg losartankalium - 25 mg hydrochlorthiazid
50 mg losartan potassium - 12.5 mg hydrochlorothiazide
Filmovertrukken tablet
Oral use
Oral anvendelse
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
COZAAR PLUS 50 MG/ 12, 5 50 mg
COZAAR PLUS FORTE 100 MG/ 25 MG
Filmovertrukken Oral anvendelse
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Chaussée de Waterloo 1135 - B - 1180 Bruxelles Belgien
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels Belgium
MG
COZAAR PLUS 50 MG/ 12,5 MG
losartankalium - tablet 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Bruxelles, Belgien
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
LOORTAN PLUS FORTE 100 MG/ 25 MG
LOORTAN PLUS FORTE 100 MG/ 25 MG
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 25 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
LOORTAN PLUS 50 MG/ 12, 5 MG
LOORTAN PLUS 50 MG/ 12,5 MG
50 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 25 mg hydrochlorthiazid
100 mg losartan potassium - 25 mg hydrochlorothiazide
2 Danmark
Denmark
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Filmovertrukken Oral anvendelse tablet
Oral use
100 mg losartankalium - 25 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Cozaar Comp. mg
Cozaar Comp.
100 mg / 12, 5
100 mg / 12,5 mg
100 mg losartankalium - 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Filmovertrukken Oral anvendelse tablets
100 mg losartan potassium – Film-coated tablets Oral use 25 mg hydrochlorothiazide
Peterburi tee 46, Tallinn 11415, Estland
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia
losartankalium - 12, 5 mg hydrochlorthiazid
HYZAAR
tablet
50 mg losartan potassium - Film-coated tablet Oral use 12.5 mg hydrochlorothiazide
Filmovertrukken Oral anvendelse tablet
100 mg losartan potassium - Film-coated tablet Oral use 25 mg hydrochlorothiazide
Waarderweg 39 P. O. Box 581 2031 BN Haarlem Holland
Waarderweg 39 P. O. Box 581 2031 BN Haarlem The Netherlands
Filmovertrukken Oral anvendelse tablet
50 mg losartan potassium - Film-coated tablet Oral use 12.5 mg hydrochlorothiazide
Finland
3 Member State
Merck Sharp & Dohme B. V.
Marketing Authorisation Holder
Cozaar Comp
Invented name
Filmovertrukken Oral anvendelse
Route of administration
losartankalium - tablet 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - 12.5 mg hydrochlorothiazide
3 Finland
Finland
Filmovertrukken Oral anvendelse
100 mg losartan potassium - 25 mg hydrochlorothiazide
Waarderweg 39 P. O. Box 581 2031 BN Haarlem Holland
Film-coated tablet
losartankalium - tablet 25 mg hydrochlorthiazid
Oral use
Hoche 75114 Paris Cedex 08 Frankrig
Hoche 75114 Paris Cedex 08 France
Fortzaar 100 mg/ 25 mg Film- coated tablets
Fortzaar 100 mg/ 25 mg film-coated tablets
Frankrig
Oral use
Hyzaar 100 mg/ 25 mg Film- coated tablets
Hyzaar 100 mg/ 25 mg film-coated tablets
Fortzaar 50 mg/ 12, 5 mg Film- coated tablets
50 mg/ 12,5 mg film-coated tablets
50 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
12.5 mg hydrochlorothiazide
Hyzaar 50 mg/ 12, 5 mg Film- coated tablets
Hyzaar 50 mg/ 12,5 mg film-coated tablets
Fortzaar 100 mg/ 12, 5 mg Film- coated tablets
losartan potassium -
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
LORZAAR VARIPHARM PLUS 50/ 12,5 mg Filmtabletten
Tatoiou Street, Nea Erythraia 14671, Grækenland
Tatoiou Street, Nea Erythraia 14671, Greece
Grækenland
Oral use
4 Holland
Hungary
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Holland
Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Cozaar Plus 100/ 12, 5
Hyzaar 50/ 12.5 mg
100 mg losartankalium - 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Holland
Hungary
Fortzaar 100/ 25
Hyzaar Forte 100/ 25 mg
100 mg losartankalium - 25 mg hydrochlorthiazid
100 mg losartan potassium - 25 mg hydrochlorothiazide
Holland
Iceland
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem Holland
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Hyzaar 50/ 12, 5
COZAAR-COMP 50/ 12.5MG
Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
‘ Cozaar ’ Comp 50mg/ 12. 5mg Film- coated tablets
COZAAR-COMP Forte
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Merck Sharp & Dohme Limited,
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
Cozaar ’ Comp 100mg/ 25mg
COZAAR-COMP 100/ 12.5MG
100 mg
Ireland
Filmovertrukken Oral anvendelse
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, Storbritannien
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
Film- coated tablets
Cozaar’ Comp 100mg/ 25mg film-coated tablets
losartankalium - tablet 25 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Fabbroni 6, 00191 Rom, Italien
Merck Sharp & Dohme Italia S. p. A. via G Fabbroni 6, 00191 Rome Italy
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 25 mg hydrochlorthiazid
losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
5 Italien
Italy
Fabbroni, 6 00191 Rom, Italien
NEO-LOTAN PLUS 50
NEO- LOTAN PLUS 50 mg + 50 mg 12, 5 mg compresse rivestite con film
50 mg losartan potassium - Film-coated tablet
losartankalium - 12, 5 mg hydrochlorthiazid
Fabbroni, 6 00191 Rome, Italy
Filmovertrukken Oral anvendelse tablet
mg + 12,5 mg compresse 12.5 mg hydrochlorothiazide rivestite con film
Fabbroni, 6 00191 Rom, Italien
Fabbroni, 6 00191 Rome, Italy
NEO- LOTAN PLUS 100 mg + 100 mg 25 mg compresse rivestite con losartankalium - film 25 mg hydrochlorthiazid
NEO-LOTAN PLUS 100 100 mg losartan potassium - Film-coated tablet mg + 25 mg compresse 25 mg hydrochlorothiazide rivestite con film
Sigma- Tau Industrie Farmaceutiche Riunite S. p. A. - viale Shakespeare 47, 00144 Rom, Italien
Sigma-Tau Industrie Farmaceutiche Riunite S. p. A. - viale Shakespeare 47, 00144 Rome, Italy
LOSAZID 50 mg + 12, 5 mg 50 mg compresse rivestite con film losartankalium - 12, 5 mg hydrochlorthiazid
LOSAZID 50 mg + 12,5 mg compresse rivestite con film
Filmovertrukken Oral anvendelse tablet
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
LOSAZID 100 mg + 25 mg 100 mg compresse rivestite con film losartankalium - 25 mg hydrochlorthiazid
LOSAZID 100 mg + 25 mg compresse rivestite con film
Filmovertrukken Oral anvendelse tablet
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Letland
oral use
SIA Merck Sharp & Dohme Lat - HYZAAR via, Latvija; Skanstes street 13, LV- 1013, Riga, Letland
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga, Latvia
50 mg/ 12, 5 mg;
HYZAAR 50 mg/ 12,5 mg
Filmovertrukken Oral anvendelse tablet
oral use
SIA Merck Sharp & Dohme Lat -
SIA Merck Sharp & Dohme Latvia, Latvija; Skanstes street 13, LV-1013, Riga, Latvia
Fortzaar 100 mg/ 25 mg 100
Fortzaar 100 mg/ 25 mg
mg
oral use
Filmovertrukken Oral anvendelse
UAB Merck Sharp & Dohme, Gelež inio Vilko 18A, LT- 01112 Vilnius Lithuania
via, Latvija; Skanstes street 13, LV- 1013, Riga, Letland
FORTZAAR (Losartan/ Hydrochlorothia zide)
losartankalium - 25 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Litauen
7 Member State
UAB Merck Sharp & Dohme, Ge - FORTZAAR ležinio Vilko 18A, (Losartan/ Hydrochlorothiazide LT - 01112 Vilnius, Litauen)
Marketing Authorisation Holder
100 mg losartankalium - 25 mg hydrochlorthiazid
Pharmaceutical Form
Filmovertrukken Oral anvendelse tablet
Route of administration
UAB Merck Sharp & Dohme, Ge - HYZAAR ležinio Vilko 18A, (Losartan/ Hydrochlorothiazide LT - 01112 Vilnius, Litauen)
UAB Merck Sharp & Dohme, Gelež inio Vilko 18A, LT- 01112 Vilnius Lithuania
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
HYZAAR (Losartan/ Hydrochlorothia zide)
Filmovertrukken Oral anvendelse tablet
50 mg losartan potassium - 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme BV - COZAAR PLUS FORTE 100 100 mg Chaussée de Waterloo 1135 - B - MG/ 25 MG 1180 Bruxelles, Belgien
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
losartankalium - 25 mg hydrochlorthiazid
COZAAR PLUS FORTE 100 MG/ 25 MG
6
Oral use
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B - 1180 Bruxelles, Belgien
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
COZAAR PLUS 50 MG/ 12, 5 50 mg MG losartankalium - 12, 5 mg hydrochlorthiazid
COZAAR PLUS 50 MG/ 12,5 MG
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Bruxelles, Belgien
Van Ophem 108 - B-1180 Brussels, Belgium
LOORTAN PLUS FORTE 100 mg 100 mg/ 25 mg losartankalium - 25 mg hydrochlorthiazid
100 mg/ 25 mg
Filmovertrukken Oral anvendelse tablet
25 mg hydrochlorothiazide
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B- 1180 Brussels, Belgien
Therabel Pharma S. A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
LOORTAN PLUS 50 mg/ 12, 5 50 mg mg losartankalium - 12, 5 mg hydrochlorthiazid
LOORTAN PLUS 50 mg/ 12,5 mg
Merck Sharp & Dohme Ltd.,
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon,
"Cozaar Comp" 50/ 12. 5 mg 50 mg
"Cozaar Comp" 50/ 12.5 mg
Hertfordshire Road, Hoddesdon, pilloli miksija b’ rita Hertfordshire, EN11 9BU, Storbritannien
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
losartankalium - 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme Ltd., "Cozaar Comp" Hertfordshire Road, Hoddesdon, 100/ 25 mg Hertfordshire, EN11 9BU, pilloli miksija b’ rita Storbritannien
Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
100 mg losartankalium - 25 mg hydrochlorthiazid
"Cozaar Comp" 100/ 25 mg pilloli miksija b’ rita
Malta
Oral use
Merck Sharp & Dohme Ltd., "Cozaar Comp" Hertfordshire Road, Hoddesdon, 100/ 12, 5 mg Hertfordshire, EN11 9BU, pilloli miksija b’ rita Storbritannien
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
100 mg losartankalium - 12, 5 mg hydrochlorthiazid
Cozaar Plus 100/ 12,5
Filmovertrukken Oral anvendelse tablet
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Polen
Oral use
HYZAAR ul.
8 Member State
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
Marketing Authorisation Holder
Filmovertrukken Oral anvendelse tablet
Invented name
Polen
Strength
MSD Polska Sp. z o. o.
Pharmaceutical Form
HYZAAR FORTE ul.
The Netherlands
Chłodna 51 00- 867 Warsawa, Polen
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
100 mg losartankalium - 25 mg hydrochlorthiazid
Fortzaar 100/ 25
Merck Sharp & Dohme, Lda.
The Netherlands
COZAAR Plus Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
Hyzaar 50/ 12,5
7
Oral use
Portugal
Norway
Merck Sharp & Dohme, Lda.
MSD BV Waarderweg 39 2031 BN Haarlem The Netherlands
COZAAR Plus
Cozaar Comp
100 mg
Norway
Filmovertrukken Oral anvendelse
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
MSD BV Waarderweg 39 2031 BN Haarlem The Netherlands
Box 214 2770- 192 Paço d 'Arcos, Portugal
Cozaar Comp Forte
losartankalium - tablet 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Merck Sharp & Dohme, Lda.
MSD Polska Sp. z o. o. ul.
Box 214 2770- 192 Paço d 'Arcos, Portugal
Chł odna 51 00-867 Warsaw Poland
FORTZAAR
HYZAAR
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 25 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Heptafarma - Companhia Far - macêutica, Sociedade Unipessoal, Lda Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
MSD Polska Sp. z o. o. ul.
SIAARA
HYZAAR FORTE
LORTAAN Plus
9 Member State
50 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
Marketing Authorisation Holder
Portugal
Invented name
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1- 1° Venda Nova 2700- 547 Amadora, Portugal
Strength
LORTAAN Plus
Pharmaceutical Form
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
Route of administration
Frosst Portuguesa – Produtos Farmacêuticos, Lda.
Merck Sharp & Dohme, Lda.
Quinte da Fonte Edificio Vasco da Gama, 19 P. O.
Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
BOX 214 Porto Salvo 2780- 730 Paço d´Arcos, Portugal
Box 214 2770-192 Paço d 'Arcos Portugal
Losartan + Hidroclorotiazida Frosst
COZAAR Plus
100 mg Filmovertrukken Oral anvendelse losartankalium - tablet 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme Romania
Film-coated tablet
HYZAAR®
Oral use
50 mg/ 12, 5 mg, 50 mg
Portugal
Bucharest Business Park Şos.
Merck Sharp & Dohme, Lda.
Bucureşti- Ploieşti, Nr.
Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
1A, Clădirea C1, Etaj 3 Sector 1, Bukarest, Rumænien
Box 214 2770-192 Paço d 'Arcos Portugal
comprimate filmate
COZAAR Plus
losartankalium - tablet 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme Romania S. R. L.
Merck Sharp & Dohme, Lda.
FORTZAAR® 100 / 25 mg,, comprimate filmate
FORTZAAR
Slovenien
Oral use
HYZAAR
Portugal
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
Heptafarma- Companhia Farmacêutica, Sociedade Unipessoal, Lda Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo P. O.
Filmovertrukken Oral anvendelse tablet
Box 214 2770-192 Paço d 'Arcos, Portugal
Slovenien
SIAARA
100 mg losartankalium - 12, 5 mg hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
Merck Sharp & Dohme, inovativna FORTZAAR zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana, Slovenien
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora, Portugal
100 mg losartankalium - 25 mg hydrochlorthiazid
LORTAAN Plus
Spanien
Oral use
C / Josefa Valcárcel, 38 28027 MADRID, Spanien
10 Member State
Spanien
Strength
C / Josefa Valcárcel, 38 28027 MADRID, Spanien
Pharmaceutical Form
Storbritannien
Portugal
Merck Sharp & Dohme Limited COZAAR- COMP 50/ 12. 5MG
LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova 2700-547 Amadora, Portugal
50 mg
LORTAAN Plus
Filmovertrukken Oral anvendelse
100 mg losartan potassium - 12.5 mg hydrochlorothiazide
Hertford Road, Hoddesdon, Herts FILM COATED TABLETS losartankalium - EN11 9BU, Storbritannien 12, 5 mg hydrochlorthiazid
Film-coated tablet
9 Storbritannien Merck Sharp & Dohme Limited
Quinte da Fonte Edificio Vasco da Gama, 19 P. O.
COZAAR- COMP 100/ 25MG 100 mg
Losartan + Hidroclorotiazida Frosst
Hertford Road, Hoddesdon, Herts FILM COATED TABLETS losartankalium - EN11 9BU, Storbritannien 25 mg hydrochlorthiazid
Film-coated tablet
Storbritannien
Romania
Merck Sharp & Dohme Limited COZAAR- Comp 100 mg Hertford Road, Hoddesdon, Herts 100 mg/ 12. 5 mg Film- coated losartankalium - EN11 9BU, Storbritannien tablets 12. 5 mg hydrochlorthiazid
1A, Clă direa C1, Etaj 3 Sector 1, Bucureş ti Romania
Filmovertrukken Oral anvendelse tablet
HYZAAR® 50 mg/ 12,5 mg, comprimate filmate
Merck Sharp & Dohme Cozaar Comp 50 mg/ 12, 5 mg 50 mg PO Box 581 filmdragerade tabletter losartankalium - 2003 PC Haarlem 12, 5 mg Holland hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Merck Sharp & Dohme Cozaar Comp 100 mg/ 12, 5 mg 100 mg PO Box 581 filmdragerade tabletter losartankalium - 2003 PC Haarlem 12, 5 mg Holland hydrochlorthiazid
1A, Clă direa C1, Etaj 3 Sector 1, Bucureş ti Romania
Filmovertrukken Oral anvendelse tablet
FORTZAAR® 100/ 25 mg, comprimate filmate
Merck Sharp & Dohme Cozaar Comp Forte 100 100 mg PO Box 581 mg/ 25 mg filmdragerade losartankalium - 2003 PC Haarlem tabletter 25 mg Holland hydrochlorthiazid
100 mg losartan potassium - Film-coated tablet 25 mg hydrochlorothiazide
MSD Chibropharm GmbH Post - LORZAAR PLUS 50/ 12, 5 mg 50 mg fach 1202 D- 85530 Haar, Tyskland Filmtabletten losartankalium - 12, 5 mg hydrochlorthiazid
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana Slovenia
Tyskland
HYZAAR
MSD Chibropharm GmbH Post - CARDOPAL PLUS 50/ 12, 5 50 mg fach 1202 D- 85530 Haar, Tyskland mg Filmtabletten losartankalium - 12, 5 mg hydrochlorthiazid
50 mg losartan potassium - Film-coated tablet 12.5 mg hydrochlorothiazide
Tyskland
11 Member State
Filmovertrukken Oral anvendelse tablet
Marketing Authorisation Holder
Tyskland
Invented name
Filmovertrukken Oral anvendelse
Pharmaceutical Form
fach 1202 D- 85530 Haar, Tyskland Filmtabletten
Route of administration
VARIPHARM ARZNEIMITTEL FORTZAAR VARIPHARM
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana Slovenia
100 mg
HYZAAR
100/ 25 mg Filmtabletten
Film-coated tablet
MSD Chibropharm GmbH Post -
Merck Sharp & Dohme, inovativna zdravila d. o. o., Smartinska cesta 140, 1000 Ljubljana Slovenia
LORZAAR PLUS forte
FORTZAAR
100 mg Filmovertrukken Oral anvendelse
100 mg losartan potassium - 25 mg hydrochlorothiazide
100/ 12, 5 mg Filmtabletten
Film-coated tablet
Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
MERCK SHARP AND DOHME DE ESPAÑA, S. A.
H- 1123 Budapest, Ungarn
C/ Josefa Valcárcel, 38 28027 MADRID Spain
Hyzaar 50/ 12. 5 mg
Cozaar Plus
Hyzaar Forte 100/ 25 mg
Fortzaar
Merck Sharp & Dohme GmbH Donau- City- Straße 6, 1220 Wien Østrig
Merck Sharp & Dohme PO Box 581 2003 PC Haarlem The Netherlands
50 mg losartankalium - 12, 5 mg hydrochlorthiazid
Cozaar Comp 50 mg/ 12,5 50 mg losartan potassium - Film-coated tablet mg filmdragerade tabletter 12.5 mg hydrochlorothiazide
100 mg losartankalium - 25 mg hydrochlorthiazid
Cozaar Comp 100 mg/ 12,5 100 mg losartan potassium - Film-coated tablet mg filmdragerade tabletter 12.5 mg hydrochlorothiazide
Island
Sweden