FrancophonIA/ELRC3.0 huggingface dataset:
Croatian: • je PRAC pregledao sve dostupne podatke iz kliničkih ispitivanja, farmakoepidemioloških ispitivanja, objavljene literature, iskustva nakon stavljanja lijeka u promet, uključujući odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet putem pisanih i oralnih pojašnjenja kao i stavove ad hoc stručne skupine o djelotvornosti i sigurnosti KHKova, posebice s obzirom na rizik od tromboembolije.
Estonian: • ravimiohutuse riskihindamise komitee vaatas läbi kõik olemasolevad andmed kliinilistest ja farmakoepidemioloogilistest uuringutest ning kirjanduses avaldatud ja turustamisjärgse kogemuse andmed, sealhulgas müügiloa hoidjate poolt kirjalikult ja suulistel selgitustel antud andmed kombineeritud hormonaalsete kontratseptiivide efektiivsuse ja ohutuse kohta, eelkõige seoses trombemboolia riskiga.
Croatian: • je PRAC zaključio da su daljnji podaci potrebni za kombinirane hormonalne kontraceptive koji sadrže klormadinon i nametnuo je provođenje ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (PASS) kako bi se ocijenio relativan rizik od tromboembolijskih događaja zato što su ovi lijekovi uspoređeni s onima koji sadrže levonorgestrel.
Estonian: • ravimiohutuse riskihindamise komitee otsustas, et kloormadinooni sisaldavate kombineeritud hormonaalsete kontratseptiivide kohta on vaja lisaandmeid, mistõttu peavad seda toimeainet sisaldavate ravimite müügiloa hoidjad tegema müügiloajärgse ohutusuuringu (PASS), et hinnata trombemboolia suhtelist riski nende toodete kasutamisel võrreldes levonorgestreeli sisaldavate kombineeritud hormonaalsete kontratseptiividega.
Croatian: • je PRAC zaključio da je, s obzirom na trenutno dostupne podatke o sigurnosti primjene, omjer koristi i rizika kombiniranih hormonalnih kontraceptiva povoljan, što je predmetom ograničenja, upozorenja i drugih izmjena u informacijama o proizvodu.
Estonian: • ravimiohutuse riskihindamise komitee otsustas, et kombineeritud hormonaalsete kontratseptiivide kasulikkuse ja riski tasakaal on jätkuvalt soodne, kui ravimite tooteinfosse lisatakse piirangud, hoiatused ja tehakse muud muudatused.
Croatian: CHMP je razmotrio niže navedenu preporuku PRAC-a od dana 10. listopada 2013. s obzirom na kombinirane hormoralne kontraceptive koji sadrže klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ili nomegestrol.
Estonian: Inimravimite komitee arutas Euroopa Ravimiameti ravimiohutuse riskihindamise komitee alltoodud 10. oktoobri 2013. aasta soovitusi, mis puudutasid kloormadinooni, desogestreeli, dienogesti, drospirenooni, etonogestreeli, gestodeeni, norelgestromiini, norgestimaati või nomegestrooli sisaldavaid kombineeritud hormonaalseid kontratseptiive.
Croatian: Rizik od VTE-a sa KHK-ovima razlikuje se među proizvodima ovisno o tipu progestogena kojeg sadrže.
Estonian: Venoosse trombemboolia risk eri kombineeritud hormonaalsete kontratseptiivide korral sõltub neis sisalduva progestogeeni tüübist.
Croatian: I u indikaciji kontracepcije ostaje povoljan, što je predmetom usuglašenih uvjeta, ograničenja, upozorenja, drugih izmjena u informacijama o lijeku i dodatnih mjera minimiziranja rizika.
Estonian: Seetõttu otsustas ravimiohutuse riskihindamise komitee, et I lisas toodud ravimite kasulikkuse ja riski tasakaal rasestumisvastasel näidustusel on jätkuvalt soodne, kui ravimite tooteinfosse lisatakse kokkulepitud tingimused, piirangud, hoiatused ja tehakse muud muudatused ning võetakse kasutusele täiendavad riskivähendamise meetmed.
Croatian: Rizik od VTE-a također je povišen u slučaju prisutnosti intrinzičnih faktora rizika.
Estonian: Venoosse trombemboolia risk on suurem ka patsiendipoolsete riskitegurite esinemisel.
Croatian: • je PRAC mišljenja da koristi lijekova koji sadrže kombinirane hormonalne kontraceptive i dalje nadmašuju rizike u indikaciji kontracepcije.
Estonian: • ravimiohutuse riskihindamise komitee arvates on kombineeritud hormonaalsete kontratseptiivide kasulikkus rasestumisvastasel näidustusel jätkuvalt suurem kui sellega seotud riskid;
Croatian: Mnoga su ispitivanja ocijenila rizik od VTE-a i njegovih komplikacija (duboke venske tromboze, pulmonalne embolije) u korisnika različitih KHK-ova.
Estonian: Venoosse trombemboolia ja selle tüsistuste (süvaveeni tromboos, kopsuemboolia) riski eri kombineeritud hormonaalsete kontratseptiivide kasutamisel on hinnatud paljudes uuringutes.
Croatian: Kraja prosinca 2018.
Estonian: 2018. aasta detsembri lõpp
Croatian: Završno izvješće o ispitivanju treba se dostaviti do:
Estonian: Uuringu lõppauranne tuleb esitada:
Croatian: Protokol ovog ispitivanja treba se dostaviti PRAC-u u roku od 6 mjeseci nakon objavljivanja Odluke EK-a.
Estonian: Nimetatud uuringu plaan tuleb ravimiohutuse riskihindamise komiteele esitada 6 kuu jooksul pärast Euroopa Komisjoni otsuse teatavakstegemist.
Croatian: Za kombinirane hormonalne kontraceptive koji sadrže klormadinon
Estonian: Kloormadinooni sisaldavad kombineeritud hormonaalsed kontratseptiivid
Croatian: Dodatak IV Uvjeti odobrenja za stavljanje lijeka u promet
Estonian: IV lisa Müügilubade tingimused
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet Nacionalna nadležna tijela država članica ili referentnih država članica, ako je primjenjivo, osigurat će da nositelji odobrenja ispune sljedeće uvjete:
Estonian: Riikide ravimiametid või vajaduse korral viiteliikmesriikide ravimiametid peavad tagama, et müügiloa hoidjad täidavad järgmisi tingimusi:
Croatian: Nositelji odobrenja za KHK-ove koji sadrže klormadinon trebaju provesti ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet kako bi se usporedio rizik od VTE s klormadinonom/ etiniestradiolom u odnosu na levonorgestrel/etiniestradiol.
Estonian: Kloormadinooni sisaldavate kombineeritud hormonaalsete kontratseptiivide müügiloa hoidjad peavad tegema müügiloajärgse ohutusuuringu, et võrrelda kloormadinooni/etinüülöstradiooli ja levonorgestreeli/etinüülöstradiooli venoosse trombemboolia riski osas.
Croatian: Francuska IDD (International Drug Development)
Estonian: Prantsusmaa IDD (International Drug Development)
Croatian: Francuska EG LABO - LABORATOIRES EUROGENERICS
Estonian: Prantsusmaa EG LABO - LABORATOIRES EUROGENERICS
Croatian: Francuska TEVA SANTE 110 Esplanade du Général de Gaulle
Estonian: Prantsusmaa TEVA SANTE 110 Esplanade du Général de Gaulle
Croatian: Francuska Laboratoires Majorelle 12 Rue de Berri
Estonian: Prantsusmaa Laboratoires Majorelle 12 Rue de Berri
Croatian: Nákladového nádraží 10 13000 Praha - 3
Estonian: U Nákladového nádraží 10 13000 Praha - 3
Croatian: Njemačka "ARAC" At Regulatory Affairs Consulting GmbH
Estonian: Saksamaa "ARAC" At Regulatory Affairs Consulting GmbH
Croatian: Njemačka MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung
Estonian: Saksamaa MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung
Croatian: Njemačka Hexal Aktiengesellschaft Industriestr.
Estonian: Saksamaa Hexal Aktiengesellschaft Industriestr.
Croatian: Francuska LABORATOIRES CRISTERS 22, quai Galliéni
Estonian: Prantsusmaa LABORATOIRES CRISTERS 22, quai Galliéni
Croatian: Španjolska FAES FARMA, S.A. Maximo Aguirre, 14.
Estonian: FAES FARMA, S.A. Maximo Aguirre, 14.
Croatian: Francuska PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue
Estonian: Prantsusmaa PFIZER HOLDING France 23-25 avenue du Docteur Lannelongue
Croatian: Rumunjska Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105
Estonian: Rumeenia Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105
Croatian: Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
Estonian: LISA I Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
Croatian: L.F. WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium
Estonian: WILL & CIE SA Rue du Manil 80 1301 Wavre Belgium
Croatian: Edward Thomsens Vej 14 DK-2300 København
Estonian: Edward Thomsens Vej 14 DK-2300 København S Denmark
Croatian: Francuska Janssen-Cilag 1 rue Camille Desmoulins TSA 91003
Estonian: Prantsusmaa Janssen-Cilag 1 rue Camille Desmoulins TSA 91003
Croatian: Njemačka Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss
Estonian: Saksamaa Janssen-Cilag GmbH Johnson & Johnson Platz 1 41470 Neuss
Croatian: Španjolska LABORATORIOS CINFA, S.A. Olaz-Chipi, 10
Estonian: LABORATORIOS CINFA, S.A. Olaz-Chipi, 10
Croatian: Francuska RANBAXY PHARMACIE GENERIQUES
Estonian: Prantsusmaa RANBAXY PHARMACIE GENERIQUES
Croatian: Francuska Bayer Sante 220 avenue de la Recherche 59120 Loos
Estonian: Prantsusmaa Bayer Sante 220 avenue de la Recherche 59120 Loos
Croatian: Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 50131 Florence
Estonian: A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - 50131 Florence
Croatian: Polígono Industrial Colón II 08228 Tarrasa
Estonian: Polígono Industrial Colón II 08228 Tarrasa Barcelona
Croatian: Francuska CHEMICAL FARMA 3, Quai Louis Blériot 75016 Paris
Estonian: Prantsusmaa CHEMICAL FARMA 3, Quai Louis Blériot 75016 Paris
Croatian: N.V. Organon Kloosterstraat 6 P.O.
Estonian: Organon Kloosterstraat 6 P.O.
Croatian: 08022 Barcelona
Estonian: 08022 Barcelona Spain
Croatian: N.V. Organon P.O.Box 20
Estonian: Organon P.O.Box 20
Croatian: Njemačka Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703
Estonian: Saksamaa Zentiva Pharma GmbH Industriepark FrankfurtHöchst, Gebäude K703
Croatian: Parque Empresarial la Moraleja 28108 Alcobendas (Madrid) Spain
Estonian: de Europa 20 B Parque Empresarial la Moraleja 28108 Alcobendas (Madrid) Spain
Croatian: Španjolska LABORATORIOS EFFIK, S.A. San Rafael, 3
Estonian: LABORATORIOS EFFIK, S.A. San Rafael, 3
Croatian: 2909 LD Capelle a/d IJssel The Netherlands
Estonian: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Croatian: Francuska SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 Paris
Estonian: Prantsusmaa SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 Paris
Croatian: Francuska BIOGARAN 15 Bd Charles de Gaulle 92700 Colombes France
Estonian: Prantsusmaa BIOGARAN 15 Bd Charles de Gaulle 92700 Colombes France
Croatian: Njemačka Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Estonian: Saksamaa Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Croatian: Rumunjska Pfizer Europe MA EEIG Ramsgate Road
Estonian: Rumeenia Pfizer Europe MA EEIG Ramsgate Road
Croatian: Rumunjska Famy Care Europe Ltd.
Estonian: Rumeenia Famy Care Europe Ltd.
Croatian: Francuska STRAGEN France SAS 52 rue de la République 69002 Lyon
Estonian: Prantsusmaa STRAGEN France SAS 52 rue de la République 69002 Lyon
Croatian: Njemačka 1 A Pharma GmbH Keltenring 1 + 3
Estonian: Saksamaa 1 A Pharma GmbH Keltenring 1 + 3
Croatian: 243 Messoghion Avenue, 154 51 N.
Estonian: 243 Messoghion Avenue, 154 51 N. Psychiko, Greece
Croatian: Njemačka Mylan dura gmbH Wittstichstr.
Estonian: Saksamaa Mylan dura gmbH Wittstichstr.
Croatian: Njemačka Varipharm Arzneimittel GmbH Lindenplatz 1
Estonian: Saksamaa Varipharm Arzneimittel GmbH Lindenplatz 1
Croatian: Temapharm Sp. z o.o. ul.
Estonian: Temapharm Sp. z o.o.
Croatian: N.V. Organon Kloosterstraat 6 5349 AB, Oss The Netherlands
Estonian: Organon Kloosterstraat 6 5349 AB, Oss The Netherlands
Croatian: Rumunjska Jenapharm GmbH & Co.
Estonian: Rumeenia Jenapharm GmbH & Co.
Croatian: Španjolska BAYER HISPANIA, S.L Avda.
Estonian: BAYER HISPANIA, S.L Avda.
Croatian: C/ Anabel Segura, 11
Estonian: C/ Anabel Segura, 11 Edificio Albatros B 1ª planta
Croatian: Rumunjska S.C. SANDOZ S.R.L.
Estonian: Rumeenia S.C. SANDOZ S.R.L.
Croatian: A 12 rue Danjou
Estonian: Le Quintet - bâtiment A 12 rue Danjou
Croatian: Francuska Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France
Estonian: Prantsusmaa Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France
Croatian: Španjolska BIAL INDUSTRIAL FARMACEUTICA, S.A.
Estonian: BIAL INDUSTRIAL FARMACEUTICA, S.A.
Croatian: 28108 Alcobendas
Estonian: 28108 Alcobendas Madrid
Croatian: Njemačka Hormosan Pharma GmbH Wilhelmshoeher Str. 106
Estonian: Saksamaa Hormosan Pharma GmbH Wilhelmshoeher Str. 106
Croatian: Njemačka Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
Estonian: Saksamaa Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
Croatian: Rumunjska Zentiva, k.s.
Estonian: Rumeenia Zentiva, k.s.
Croatian: Rumunjska N.V.
Estonian: Rumeenia N.V.
Croatian: Nizozemska WeCare, Lagedijk 1-3;
Estonian: Lagedijk 1-3;
Croatian: Rumunjska Bayer Pharma AG Muellerstrasse 170-178
Estonian: Rumeenia Bayer Pharma AG Muellerstrasse 170-178
Croatian: Njemačka UCB Pharma GmbH Alfred-Nobel-Str. 10
Estonian: Saksamaa UCB Pharma GmbH Alfred-Nobel-Str. 10
Croatian: Njemačka Aristo Pharma GmbH Wallenroder Straße 8-10
Estonian: Saksamaa Aristo Pharma GmbH Wallenroder Straße 8-10
Croatian: Rumunjska Teva Pharmaceuticals S.R.L.
Estonian: Rumeenia Teva Pharmaceuticals S.R.L.
Croatian: Rumunjska Ivowen Limited 3 Anglesa St
Estonian: Rumeenia Ivowen Limited 3 Anglesa St
Croatian: Nizozemska Teva Nederland B.V.
Estonian: Teva Nederland B.V.
Croatian: Njemačka Ivowen Limited 3 Anglesa St
Estonian: Saksamaa Ivowen Limited 3 Anglesa St
Croatian: Rumunjska LadeePharma Kft Lajos utca 48-66
Estonian: Rumeenia LadeePharma Kft Lajos utca 48-66
Croatian: VIVAX EuroAsia s.r.o. Karloveske rameno 6 841 01 Bratislava Slovensko
Estonian: Karloveske rameno 6 841 01 Bratislava Slovensko
Croatian: Njemačka Jenapharm GmbH & Co.
Estonian: Saksamaa Jenapharm GmbH & Co.
Croatian: Dienogest Etinilestradiol maxim
Estonian: Dienogest Ethinylestradiol maxim
Croatian: Bayer, spol. s r.o. Digital Park II Einsteinova 25
Estonian: Digital Park II Einsteinova 25
Croatian: 2031 GA Haarlem
Estonian: 2031 GA Haarlem The Netherlands
Croatian: Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
Estonian: Marszałka J. Piłsudskiego 5 95-200 Pabianice Poland
Croatian: Rumunjska Bayer Pharma AG Muellerstr.
Estonian: Rumeenia Bayer Pharma AG Muellerstr.
Croatian: Francuska EFFIK 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France
Estonian: Prantsusmaa EFFIK 9-11 rue Jeanne Braconnier Bâtiment « Le Newton » 92366 Meudon la Foret cedex France
Croatian: JANSSEN-CILAG N.V. Antwerpseweg 15-17 2340 Beerse Belgium
Estonian: Antwerpseweg 15-17 2340 Beerse Belgium
Croatian: Francuska ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
Estonian: Prantsusmaa ZYDUS FRANCE ZAC Les Hautes Patures 25 Rue des peuliers 92752 Nanterre Cedex France
Croatian: C/ La Vallina s/n, Pol.
Estonian: C/ La Vallina s/n, Pol. Ind., Navatejera
Croatian: Francuska Arrow Generiques 26 avenue Tony Garnier 69007 Lyon
Estonian: Prantsusmaa Arrow Generiques 26 avenue Tony Garnier 69007 Lyon
Croatian: Dr. Kade Pharmazeutische Fabrik GmbH
Estonian: Kade Pharmazeutische Fabrik GmbH
Croatian: Francuska Arrow génériques SAS 26 Avenue Tony Garnier 69007 Lyon
Estonian: Prantsusmaa Arrow génériques SAS 26 Avenue Tony Garnier 69007 Lyon
Croatian: Nizozemska EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Estonian: Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrijk
Croatian: Španjolska Famy Care Europe Ltd.
Estonian: Famy Care Europe Ltd.
Croatian: Njemačka Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11
Estonian: Saksamaa Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Croatian: Nizozemska betapharm Arzneimittel GmbH Kobelweg 95
Estonian: Holland betapharm Arzneimittel GmbH Kobelweg 95
Croatian: Španjolska MYLAN PHARMACEUTICALS S.L.
Estonian: MYLAN PHARMACEUTICALS S.L.
Croatian: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Estonian: Rue Saint Georges 5 4000 Liège
Croatian: Španjolska QUALITEC EUROPA, S.L Paseo Pintor Rosales, 42
Estonian: QUALITEC EUROPA, S.L Paseo Pintor Rosales, 42 28008 Madrid Spain
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline continu 0,15 mg 0,03 mg
Estonian: Prantsusmaa MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline continu 0,15 mg 0,03 mg
Croatian: Scarlatti, 31 20124 Milano Italy
Estonian: Via D. Scarlatti, 31 20124 Milano Italy
Croatian: Španjolska ACTAVIS SPAIN, S.A. Avda. de Burgos, 16-D 28036 Madrid
Estonian: de Burgos, 16-D 28036 Madrid Spain
Croatian: Španjolska GEDEON RICHTER, PLC Gyömroi ut 19-21
Estonian: GEDEON RICHTER, PLC Gyömroi ut 19-21
Croatian: 08960 Sant Just Desvern Barcelona
Estonian: Frederic Mompou, 5 08960 Sant Just Desvern Barcelona
Croatian: WH-Pharma s.r.o. Talafusova 970
Estonian: Talafusova 970
Croatian: Rowex Ltd Bantry Co.
Estonian: Rowex Ltd Bantry Co. Cork Ireland
Croatian: Alkotás street 53 Budapest 1123
Estonian: Pfizer Hungary LTD. Alkotás street 53 Budapest 1123
Croatian: 1327 AH Almere The Netherlands
Estonian: Veluwezoom 22 1327 AH Almere The Netherlands
Croatian: Španjolska Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38
Estonian: Merck Sharp and Dohme de España, S.A c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)
Croatian: Boccioni, 1 21040 Origgio (VA) Italy
Estonian: Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
Croatian: Njemačka Ratiopharm GmbH Graf-Arco-Strasse 3
Estonian: Saksamaa Ratiopharm GmbH Graf-Arco-Strasse 3
Croatian: Njemačka betapharm Arzneimittel GmbH Kobelweg 95
Estonian: Saksamaa betapharm Arzneimittel GmbH Kobelweg 95
Croatian: Dezogestrel/ Etinylestradiol
Estonian: Desogestrel/ Etinylestradiol
Croatian: Njemačka Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
Estonian: Saksamaa Helm AG Nordkanalstrasse 28 20097 Hamburg Germany
Croatian: POTAHOVANÝCH TABLET
Estonian: POTAHOVANÝCH TABLETT
Croatian: Nizozemska Bayer B.V.
Estonian: Bayer B.V.
Croatian: Nizozemska Mylan B.V.
Estonian: Mylan B.V.
Croatian: Francuska SANDOZ 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France
Estonian: Prantsusmaa SANDOZ 49 avenue Georges Pompidou 92593 Levellois-Perret Cedex France
Croatian: Luksemburg Teva Pharma Belgium N.V. Laarstraat 16
Estonian: Luksemburg Teva Pharma Belgium N.V.
Croatian: Nizozemska Berlipharm B.V.
Estonian: Berlipharm B.V.
Croatian: Francuska SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Estonian: Prantsusmaa SANDOZ 49 avenue Georges Pompidou 92593 Levallois-Perret Cedex France
Croatian: Španjolska Actavis Group PTC ehf Reykjavikurvegi 76-78
Estonian: Saksamaa Actavis Group PTC ehf Reykjavikurvegi 76-78
Croatian: Teva Italia S.r.l. via Messina 38 20154 Milano Italy
Estonian: via Messina 38 20154 Milano Italy
Croatian: Nizozemska Velvian Germany GmbH Carl-Zeiss-Ring 9
Estonian: Saksamaa Velvian Germany GmbH Carl-Zeiss-Ring 9
Croatian: Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19
Estonian: Zakłady Farmaceutyczne POLPHARMA S.A. ul.
Croatian: Rumunjska Johnson & Johnson d.o.o. Šmartinska cesta 53
Estonian: Rumeenia Johnson & Johnson d.o.o.
Croatian: Sun-Farm Sp. z o.o. Człekówka 75
Estonian: Sun-Farm Sp. z o.o.
Croatian: Nizozemska Apothecon B.V.
Estonian: Apothecon B.V.
Croatian: Johnson & Johnson, s. r. o.
Estonian: Johnson & Johnson d.o.o.
Croatian: Nizozemska Sandoz B.V.
Estonian: Sandoz B.V.
Croatian: Dienogest Etinilestradiol ladonna sanol 2 mg /0,03 mg
Estonian: Dienogest Ethinylestradiol ladonna sanol 2 mg /0,03 mg
Croatian: Luksemburg Mithra Pharmaceuticals S.A. Rue Saint Georges 5
Estonian: Luksemburg Mithra Pharmaceuticals S.A.
Croatian: Ltd One Wood Street EC2V 7WS London United Kingdom
Estonian: One Wood Street EC2V 7WS
Croatian: Nizozemska LadeePharma Kft Lajos u 48-66 1036
Estonian: LadeePharma Kft Lajos u 48-66 1036 Budapest
Croatian: Španjolska TEVA PHARMA S.L.U.
Estonian: TEVA PHARMA S.L.U.
Croatian: H-1103 Budapest
Estonian: H-1103 Budapest Hungary
Croatian: Njemačka Madaus GmbH Colonia Allee 15
Estonian: Saksamaa Madaus GmbH Colonia Allee 15
Croatian: Nizozemska Pfizer B.V.
Estonian: Pfizer B.V.
Croatian: Njemačka Pharbil Waltrop GmbH Im Wirrigen 25
Estonian: Saksamaa Pharbil Waltrop GmbH Im Wirrigen 25
Croatian: 0,15 mg/0,02 mg Tableta
Estonian: 0,15 mg/0,02 mg Tablett
Croatian: Slovenija sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia
Estonian: Dunajska cesta 151 1000 Ljubljana Slovenia
Croatian: Nizozemska Janssen-Cilag B.V.
Estonian: Janssen-Cilag B.V.
Croatian: Španjolska SANDOZ FARMACÉUTICA, S.A. Avda.
Estonian: SANDOZ FARMACÉUTICA, S.A. Avda.
Croatian: 28B III/5 1095 Budapest Hungary
Estonian: Aramis Pharma Kft. Mester u. 28B III/5 1095 Budapest Hungary
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Estonian: Prantsusmaa MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France
Croatian: 53 Budapest 1123 Hungary
Estonian: Alkotás u. 53 Budapest 1123 Hungary
Croatian: Nizozemska Centrafarm B.V.
Estonian: Centrafarm B.V.
Croatian: Plom, 2-4, 5ª planta
Estonian: Plom, 2-4, 5ª planta 08038 Barcelona Spain
Croatian: Španjolska SANDOZ FARMACEUTICA, S.A. Avda.
Estonian: SANDOZ FARMACEUTICA, S.A. Avda.
Croatian: Rumunjska Medico Uno Pharma Kft.
Estonian: Rumeenia Medico Uno Pharma Kft. Viadukt u. 12
Croatian: Španjolska Schering - Plough S.A. c/ Josefa Valcárcel, 38
Estonian: Schering - Plough S.A. c/ Josefa Valcárcel, 38 28027 Madrid España (Spain)
Croatian: Njemačka TEVA GmbH Graf-Arco-Str.
Estonian: Saksamaa TEVA GmbH Graf-Arco-Str. 3
Croatian: Francuska MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline
Estonian: Prantsusmaa MSD France 34 avenue Léonard de Vinci 92418 Courbevoie Cedex France varnoline
Croatian: Johnson & Johnson d.o.o. Šmartinska cesta 53 1000 Ljubljana Slovenija
Estonian: Šmartinska cesta 53 1000 Ljubljana Slovenija
Croatian: Španjolska WYETH FARMA, S.A. Ctra. de Burgos, Km 23.
Estonian: WYETH FARMA, S.A. Ctra.
Croatian: Pfizer, spol. s r.o.
Estonian: Pfizer, spol.
Croatian: Etinilestradiol Gestoden
Estonian: Ethinylestradiol Gestodene
Croatian: Rumunjska Bayer Pharma AG D-13342 Berlin
Estonian: Rumeenia Bayer Pharma AG D-13342 Berlin
Croatian: Etonogestrel Etinilestradiol
Estonian: Etonogestrel Ethinylestradiol
Croatian: Sandoz Pharmaceuticals d.d. Verovškova 57
Estonian: Sandoz Pharmaceuticals d.d.
Croatian: Zaštitite druge ljude
Estonian: Teiste inimeste kaitsmine
Croatian: • ako ste ozbiljno pretili (posebice ako ste žena)
Estonian: • kui te olete tõsiselt ülekaaluline (eriti kui te olete naine).
Croatian: • ako konzumiraju alkohol
Estonian: • kui nad tarbivad alkoholi
Croatian: Nemojte voziti ili koristiti strojeve ako se ne osjećate dobro.
Estonian: Ärge juhtige autot ega käsitsege masinaid, kui te ei tunne end hästi.
Croatian: Geometrijska sredina promjene (%) (Mogući mehanizam)
Estonian: Geomeetriline keskmine muutus (%) (võimalik mehhanism)
Croatian: Zato je vrlo važno da svog liječnika obavijestite o svim promjenama Vašeg zdravstvenog stanja.
Estonian: Seetõttu on väga tähtis, et te informeeriksite arsti kõigist oma tervisliku seisundi muutustest.
Croatian: Obratite pozornost na važne simptome
Estonian: Jälgige olulisi sümptomeid
Croatian: Studije interakcija provedene su samo kod odraslih.
Estonian: Koostoimete uuringud on läbi viidud ainult täiskasvanutel.
Croatian: Niti jedan slučaj nije završio smrću i svi su se bolesnici oporavili.
Estonian: Surmajuhtumeid ei ole esinenud ja kõik patsiendid on paranenud.
Croatian: • duboko, ubrzano, otežano disanje
Estonian: • sügav, kiire ja raske hingamine
Croatian: • ako je imunološki sustav vrlo oslabljen
Estonian: • kui nende immuunsüsteem on väga nõrk
Croatian: Datum posljednje obnove odobrenja: 13. veljače 2008.
Estonian: Müügiloa uuendamise kuupäev: 13. veebruar 2008
Croatian: • ako su uzimali kombiniranu terapiju kroz duže razdoblje
Estonian: • kui nad on saanud kombineeritud ravi pikka aega
Croatian: Drugi lijekovi i Combivir
Estonian: Muud ravimid ja Combivir
Croatian: Ako imate bilo koji od gore navedenih simptoma ili bilo koje druge simptome koji Vas zabrinjavaju:
Estonian: Kui teil on mõni ülalnimetatud sümptomitest või kui mõni muu sümptom teile muret teeb:
Croatian: Kako Combivir izgleda i sadržaj pakiranja
Estonian: Kuidas Combivir välja näeb ja pakendi sisu
Croatian: Autoimuni poremećaji mogu se pojaviti mnogo mjeseci nakon početka liječenja.
Estonian: Autoimmuunsed häired võivad tekkida mitu kuud pärast ravi algust.
Croatian: Ako ste primijetili neki od ovih simptoma:
Estonian: Kui te täheldate selliseid sümptomeid: