FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg Eurogenerics SA Esplanade Heysel b22
Swedish: Luxemburg Eurogenerics SA Esplanade Heysel b22
English: DK-2970 Hørsholm
Swedish: DK-2970 Hørsholm Denmark
English: 90449 Nürnberg
Swedish: 90449 Nürnberg Germany
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Swedish: Lettland sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
English: Finland Sanofi Oy Huopalahdentie 24 PL 22
Swedish: Sanofi Oy Huopalahdentie 24 PL 22
English: Sweden Sanofi AB Box 30052
Swedish: Sanofi AB Box 30052
English: 61118 Bad Vilbel
Swedish: 61118 Bad Vilbel Germany
English: Germany Mylan dura GmbH Wittichstr.
Swedish: Mylan dura GmbH Wittichstr.
English: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Swedish: Österrike sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
English: 02101 Espoo
Swedish: 02101 Espoo Finland
English: Winthrop Pharmaceuticals UK Limited
Swedish: Storbritannien Winthrop Pharmaceuticals UK Limited
English: 86156 Augsburg
Swedish: 86156 Augsburg Germany
English: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus
Swedish: Remedica Ltd Aharnon Street Limassol Industrial Estate 3056 Lemesos Cyprus valproate sodium
English: Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Swedish: Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
English: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Swedish: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
English: Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Swedish: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Lithuania UAB „SANOFI-AVENTIS LIETUVA“
Swedish: UAB „SANOFI-AVENTIS LIETUVA“
English: Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Swedish: GEROT PHARMAZEUTIKA Ges.m.b.H.
English: Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Swedish: Sanofi-aventis Ireland Ltd. T/A SANOFI
English: Luxembourg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Swedish: Luxemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Swedish: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2
English: 83607 Hozkirchen
Swedish: 83607 Hozkirchen Germany
English: Luxembourg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Swedish: Luxemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
English: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands
Swedish: Veluwezoom 22 1327 AH ALMERE The Netherlands
English: Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Swedish: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
English: 1080 Brussels
Swedish: 1080 Bruxelles
English: Germany Stadapharm GmbH Stadastr 2-18
Swedish: Stadapharm GmbH Stadastr 2-18
English: Gebäude K703
Swedish: Industriepark Höchst Gebäude K703
English: Denmark Sanofi-aventis Denmark A/S
Swedish: Sanofi-aventis Denmark A/S
English: Valproic acid Convulex gelule gastro résistante
Swedish: Valproinsyra Convulex gelule gastro résistante
English: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Swedish: Storbritannien Generics UK Limited Station Close, Potter's Bar Hertfordshire
English: Oral liquid
Swedish: Oral vätska
English: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Swedish: Darwinweg 20 2333 CR LEIDEN The Netherlands
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Swedish: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
English: Germany Sanofi-Aventis Deutschland GmbH
Swedish: Sanofi-Aventis Deutschland GmbH
English: Valproic acid Ácido Valpróico Generis
Swedish: Valproinsyra Ácido Valpróico Generis
English: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Swedish: Swensweg 5 2031 GA HAARLEM The Netherlands
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Swedish: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
English: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Swedish: Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
English: Finland Orion Pharma Orionintie 1
Swedish: Orion Pharma Orionintie 1 PL 65
English: Germany Neuraxpharm Arzneimittel GmbH
Swedish: Neuraxpharm Arzneimittel GmbH
English: 500-1000 mg Modified-release granules
Swedish: 500-1000 mg Granulat med modifierad frisättning
English: Germany Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Swedish: Storbritannien Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Valproic acid VALPROATE SODIUM SANDOZ 500MG
Swedish: Valproinsyra VALPROATE SODIUM SANDOZ 500MG
English: Depakine Chronosphere 250 166.76 mg 72.61 mg
Swedish: Depakine Chronosphere 250 (166,76 mg + 72,61 mg)/sachet
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Swedish: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Dragerade granulat i dospåse
English: Germany Winthrop Arzneimittel GmbH
Swedish: Winthrop Arzneimittel GmbH
English: Depakine Chronosphere 100 66,66 mg 29.03 mg
Swedish: Depakine Chronosphere 100 (66,66 mg + 29,03 mg)/sachet
English: Valproic acid CONVULEX 100 mg/ml oldatos injekció
Swedish: Valproinsyra CONVULEX 100 mg/ml oldatos injekció
English: Modified-release granules
Swedish: Granulat med modifierad frisättning
English: Valproic acid ORFIRIL SAFT
Swedish: Valproinsyra ORFIRIL SAFT
English: Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Swedish: Valproinsyra DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Swedish: Storbritannien Ratiopharm GmbH Graf-Arco-Strasse 3
English: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Swedish: Takeda Belgien Gentsesteenweg 615 1080 Brussels Belgium
English: LT-09310 Vilnius
Swedish: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
English: Germany G.L.
Swedish: Storbritannien G.L.
English: Valproic acid Orfiril Retard
Swedish: Valproinsyra Orfiril Retard
English: Powder for injection Intravenous use
Swedish: Pulver till injektionsvätska
English: One Onslow Street Guildford, Surrey GU1 4YS
Swedish: Guildford, Surrey
English: Valproic acid Diplexil
Swedish: Valproinsyra Diplexil
English: Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Swedish: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany
English: Valproic acid CONVULEX 50 mg/ml szirup gyermekeknek
Swedish: Valproinsyra CONVULEX 50 mg/ml szirup gyermekeknek
English: Valproic acid Orfiril Long
Swedish: Valproinsyra Orfiril Long
English: Valproic acid Valproat "Sandoz"
Swedish: Valproinsyra Valproat "Sandoz"
English: Germany betapharm Arzneimittel GmbH
Swedish: betapharm Arzneimittel GmbH
English: Romania S.C.
Swedish: S.C.
English: Valproic acid Depakine 400 mg/4 ml
Swedish: Valproinsyra Depakine 400 mg/4 ml
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Swedish: Convulex 300 mg/mlLösung zum Einnehmen
English: Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Swedish: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
English: Valproic acid Convulex 50 mg/ml - Sirup für Kinder
Swedish: Valproinsyra Convulex 50 mg/ml - Sirup für Kinder
English: Belgium Takeda Belgium Gentsesteenweg 615
Swedish: Luxemburg Takeda Belgium Chaussée de Gand 615
English: Valproic acid Convulex 100 mg/mlInjektionslösung
Swedish: Valproinsyra Convulex 100 mg/mlInjektionslösung
English: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Swedish: Storbritannien Aventis Pharma Limited One Onslow Street
English: Valproic acid Depakine Chronosphere
Swedish: Valproinsyra Depakine Chronosphere
English: Valproic acid DEPAKINE 50 mg/ml szirup 50 mg/ml
Swedish: Valproinsyra DEPAKINE 50 mg/ml szirup 50 mg/ml
English: Valproic acid Diplexil 1000
Swedish: Valproinsyra Diplexil 1000
English: Germany 1 A Pharma GmbH Keltenring 1 + 3
Swedish: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
English: Valproic acid ORFIRIL 150
Swedish: Valproinsyra ORFIRIL 150
English: Valproic acid ORFIRIL 600
Swedish: Valproinsyra ORFIRIL 600
English: 13435 Berlin espa-valept 300 mg retard 199.8 mg, 87 mg
Swedish: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany espa-valept 300 mg retard 199.8 mg, 87 mg
English: Valproic acid Diplexil 150
Swedish: Valproinsyra Diplexil 150
English: 104 25 Stockholm Sweden
Swedish: 104 25 Stockholm Sweden valproinsyra natriumvalpr oat
English: Valproic acid Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Swedish: Valproinsyra Depakine chrono 300 mg tablete s podaljšanim sproščanjem
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Swedish: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
English: Valproic acid ORFIRIL 300
Swedish: Valproinsyra ORFIRIL 300
English: Valproic acid Convulex 300 mg - Kapseln 300 mg
Swedish: Valproinsyra Convulex 300 mg - Kapseln 300 mg
English: Valproic acid Absenor 300 mg tablety s predĺženým uvoľňovaním
Swedish: Valproinsyra Absenor 300 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Swedish: Valproinsyra Depakine chrono 500 mg tablete s podaljšanim sproščanjem
English: Valproic acid CONVULEX RETARD 500MG 500 mg
Swedish: Valproinsyra CONVULEX RETARD 500MG 500 mg
English: Valproic acid Absenor 500 mg tablety s predĺženým uvoľňovaním
Swedish: Valproinsyra Absenor 500 mg tablety s predĺženým uvoľňovaním
English: Valproic acid CONVULEX RETARD 300MG 300 mg
Swedish: Valproinsyra CONVULEX RETARD 300MG 300 mg
English: Valproic acid Convulex 150
Swedish: Valproinsyra Convulex 150
English: Valproic acid Convulex 500 mg - Kapseln 500 mg
Swedish: Valproinsyra Convulex 500 mg - Kapseln 500 mg
English: Valproic acid Delepsine
Swedish: Valproinsyra Delepsine
English: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Swedish: Luxemburg Hexal AG Industriestrasse 25
English: Valproic acid Convulex 150 mg - Kapseln 150 mg
Swedish: Valproinsyra Convulex 150 mg - Kapseln 150 mg
English: Valproic acid Convulex Capsules 150mg 150 mg
Swedish: Valproinsyra Convulex Capsules 150mg 150 mg
English: Coated granules in sachet
Swedish: Dragerade granulat i dospåse
English: Valproic acid CONVULEX 300 MG/ML
Swedish: Valproinsyra CONVULEX 300 MG/ML
English: Depakine Chronosphere 500 333.30 mg 145,14 mg
Swedish: Depakine Chronosphere 500 (333,30 mg + mg)/sachet
English: Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Swedish: Valproinsyra CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
English: Oral drops, solution Oral Use
Swedish: Depotkapsel, hård Oral användning
English: Solution for injection/infusion
Swedish: Injektions- och infusionsvätska, lösning
English: Valproid acid, Sodium valproate
Swedish: Valproate sodium, Valproinsyra
English: Valproic acid Diplexil 500
Swedish: Valproinsyra Diplexil 500
English: Valproic acid Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
Swedish: Valproinsyra Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
English: Valproic acid Diplexil 300
Swedish: Valproinsyra Diplexil 300
English: Depakine Chronosphere 1000 666,60 mg 290.27 mg
Swedish: Depakine Chronosphere 1000 (666,60 mg + mg)/sachet
English: Valproic acid DEPAKINE CHRONO 300 MG 300 mg
Swedish: Valproinsyra DEPAKINE CHRONO 300 MG 300 mg
English: Valproic acid Convulex 150 mg gastroresistant capsules, soft
Swedish: Valproinsyra Convulex 150 mg gastroresistant capsules, soft
English: Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Swedish: Valproinsyra CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
Swedish: Valproinsyra Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
English: Film-coated tablet Oral Use
Swedish: Enterokapsel, mjuk Oral användning
English: Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Swedish: Valproinsyra CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Convulex 300 mg gastroresistant capsules, soft
Swedish: Valproinsyra Convulex 300 mg gastroresistant capsules, soft
English: Valproic acid Convulex 500
Swedish: Valproinsyra Convulex 500
English: Valproic acid Convulex Capsules 300mg 500 mg
Swedish: Valproinsyra Convulex Capsules 300mg 500 mg
English: Gastroresistant tablets
Swedish: Dragerad tablett
English: Valproic acid Convulex 300 mg kapsuly
Swedish: Valproinsyra Convulex 300 mg kapsuly
English: Valproic acid Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
Swedish: Valproinsyra Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
English: Valproic acid Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
Swedish: Valproinsyra Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
English: Valproic acid ORFIRIL LONG 1000 MG 1000 mg
Swedish: Valproinsyra ORFIRIL LONG 1000 MG 1000 mg
English: Valproic acid Convulex 150 mg kapsuly
Swedish: Valproinsyra Convulex 150 mg kapsuly
English: Valproic acid Convulex Capsules 500mg 300 mg
Swedish: Valproinsyra Convulex Capsules 500mg 300 mg
English: Elisabeth-Selbert-Str. 23
Swedish: Elisabeth-Selbert-Str. 23 40764 Langelfeld Germany
English: Valproic acid Convulex 300
Swedish: Valproinsyra Convulex 300
English: Valproic acid Convulex 500 mg gastroresistant capsules, soft
Swedish: Valproinsyra Convulex 500 mg gastroresistant capsules, soft
English: Valproic acid Convulex
Swedish: Valproinsyra CONVULEX
English: Valproic acid CONVULEX
Swedish: Valproinsyra Convulex
English: Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Swedish: Valproinsyra Propymal Enteric 150 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Swedish: Valproinsyra Propymal Enteric 600 mg, maagsapresistente capsules
English: Valproic acid Convulex 500 mg kapsuly
Swedish: Valproinsyra Convulex 500 mg kapsuly
English: Valproic acid DEPAKINE CHRONO 500 MG 500 mg
Swedish: Valproinsyra DEPAKINE CHRONO 500 MG 500 mg
English: Valproic acid CONVULEX 150 MG
Swedish: Valproinsyra CONVULEX 150 MG
English: Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Swedish: Valproinsyra Propymal Enteric 450 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Swedish: Valproinsyra Propymal Enteric 300 mg, maagsapresistente capsules
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Swedish: TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany
English: Valproic acid ORFIRIL LONG 150 MG
Swedish: Valproinsyra ORFIRIL LONG 150 MG
English: Valproic acid ORFIRIL
Swedish: Valproinsyra ORFIRIL
English: Valproic acid Orfiril
Swedish: Valproinsyra Orfiril
English: Depakine Chronosphere 750 500,06 mg 217,75 mg
Swedish: Depakine Chronosphere 750 (500,06 mg + mg)/sachet
English: Valproic acid Depakine Chrono 500
Swedish: Valproinsyra Depakine Chrono 500
English: Valproic acid ORFIRIL LONG 300 MG
Swedish: Valproinsyra ORFIRIL LONG 300 MG
English: 13435 Berlin espa-valept 500 mg retard 333 mg, 145 mg
Swedish: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany espa-valept 500 mg retard 333 mg, 145 mg
English: Valproic acid ORFIRIL LONG 500 MG
Swedish: Valproinsyra ORFIRIL LONG 500 MG
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Swedish: Heizel Esplanade b22 1020 Brussels Belgium
English: Valproic acid
Swedish: Valproid Acid,
English: Powder and solvent for solution for injection/infusion
Swedish: Pulver och vätska till injektions- och infusionsvätska, lösning
English: MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose
Swedish: 750 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid Convulex 300 mg
Swedish: Valproinsyra CONVULEX 300 MG
English: Valproic acid CONVULEX 300 MG
Swedish: Valproinsyra Convulex 300 mg
English: MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
Swedish: 1000 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid Delepsine Retard
Swedish: Valproinsyra Delepsine Retard
English: Valproic acid CONVULEX 500 MG
Swedish: Valproinsyra CONVULEX 500 MG
English: MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose
Swedish: 250 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose
Swedish: 500 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose
Swedish: 100 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid Depakine
Swedish: Valproinsyra Depakine
English: Valproic acid DEPAKINE
Swedish: Valproinsyra DEPAKINE
English: Valproic acid Depakine Chrono 300
Swedish: Valproinsyra Depakine Chrono 300
English: Gastro-resistant film-coated tablet
Swedish: Filmdragerad depottablett
English: Depakine Crono 300 mg comprimidos recubiertos
Swedish: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Depakine Crono 500 mg comprimidos recubiertos
Swedish: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Valproat Aristo 600 mg magensaftresistente Filmtabletten
Swedish: Valproat Aristo 600 mg magensaftresistente Filmtabletten betapharm Arzneimittel GmbH
English: Valpro beta chrono 300 mg Retardtabletten
Swedish: Valpro beta chrono 300 mg Retardtabletten betapharm Arzneimittel GmbH
English: Valproic acid CONVULEX 500 mg retard filmtabletta prolonged release film-coated tablet
Swedish: Valproinsyra CONVULEX 500 mg retard filmtabletta
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Swedish: Ändringarna i de relevanta avsnitten av produktresumén och bipacksedeln återfinns i bilaga III.
English: The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Swedish: Godkännandena för försäljning av klormadinon-innehållande kombinerade hormonella preventivmedel är underställda de villkor som anges i bilaga IV.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied.
Swedish: Efter att ha övervägt PRAC:s rekommendation av den 10 oktober 2013 i enlighet med artikel 107k.3 i direktiv 2001/83/EG anser CHMP att godkännandena för försäljning av kombinerade hormonella preventivmedel innehållande klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norgestimat bör ändras.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation
Swedish: Vetenskapliga slutsatser och skäl till ändringen av villkoren för godkännanden för försäljning och detaljerad förklaring av skillnaderna från rekommendationen från kommittén för säkerhetsövervakning och riskbedömning av läkemedel
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Swedish: Till följd av detta fann PRAC att nytta-riskförhållandet för de läkemedel som identifierats i bilaga I förblir gynnsamt vid indikationen antikonception, under förutsättning av överenskomna begränsningar, varningar och övriga ändringar i produktinformationen samt kompletterande riskminimeringsåtgärder.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Swedish: Efter att ha övervägt detta fann PRAC att nytta-riskförhållandet för de läkemedel som identifierats i bilaga I förblir gynnsamt vid indikationen, antikonception, förutsatt att de överenskomna begränsningarna, varningarna och övriga ändringar läggs in i produktinformationen.
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Swedish: Datum för det första godkännandet: 21 mars 2007 Datum för den senaste förnyelsen: 23 februari 2012
English: Other medicines and Januvia
Swedish: Andra läkemedel och Januvia
English: What Januvia is and what it is used for
Swedish: Vad Januvia är och vad det används för
English: STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
Swedish: SLUTA ta Januvia och kontakta läkare omedelbart om du märker någon av följande allvarliga biverkningar:
English: Your doctor may ask you to stop Januvia.
Swedish: Din läkare kan säga till dig att sluta ta Januvia.
English: It is important to stay on the diet and exercise recommended by your doctor while taking Januvia.
Swedish: Det är viktigt att fortsätta med den kost och motion som läkaren rekommenderat under tiden du tar Januvia.
English: If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
Swedish: Om en dos av Januvia missats, bör den tas så snart som patienten kommer ihåg.
English: Due to lack of human data, Januvia should not be used during pregnancy.
Swedish: I avsaknad av humandata bör Januvia inte användas under graviditet.
English: The level of digoxin in your blood may need to be checked if taking with Januvia.
Swedish: Nivån av digoxin i blodet kan behöva kontrolleras om det tas tillsammans med Januvia.
English: Do not take Januvia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Swedish: Använd inte Januvia - om du är allergisk mot sitagliptin eller något annat innehållsämne i detta läkemedel (anges i avsnitt 6).
English: Method of administration Januvia can be taken with or without food.
Swedish: Administreringssätt Januvia kan intas med eller utan föda.
English: What you need to know before you take Januvia
Swedish: Vad du behöver veta innan du tar Januvia
English: Incidenc e rate per 100 patientyears* N (%)
Swedish: Incidensen per 100 patientår* N (%)
English: Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Swedish: Allmänt Januvia ska inte användas till patienter med typ 1-diabetes eller för behandling av diabetesketoacidos.
English: If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted.
Swedish: Om man misstänker pankreatit ska behandling med Januvia och andra potentiellt misstänkta läkemedel sättas ut. Om akut pankreatit bekräftas bör Januvia inte återinsättas.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
Swedish: Eftersom dosjustering baseras på njurfunktion rekommenderas att en bedömning av njurfunktionen görs före påbörjad behandling med Januvia och därefter regelbundet.
English: If you have kidney problems, your doctor may prescribe lower doses(such as 25mg or 50mg).
Swedish: Om du har njurbesvär är det möjligt att läkaren förskriver lägre doser till dig (såsom 25 mg eller 50 mg).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Swedish: Europeiska läkemedelsmyndigheten har senarelagt kravet att skicka in studieresultat för Januvia för en eller flera grupper av den pediatriska populationen för diabetes mellitus typ 2 (se avsnitt 4.2 för information om pediatrisk användning).