FrancophonIA/ELRC3.0 huggingface dataset:
English: Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Romanian: Germania neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Romanian: Danemarca Meda AS, Solvang 8, DK-3450 Allerød, Denmark
English: Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Romanian: Luxemburg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
English: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Romanian: Marea Britanie Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
English: PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark
Romanian: Danemarca PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Romanian: calea de administrare a medicamentelor, deţinătorii autorizaţiei de punere pe piaţă în Statele Membre
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Romanian: Olanda ratiopharm Nederland B.V. Swensweg 5
English: Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
Romanian: Marea Britanie Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
English: Sanofi Malta Ltd. St. Julian's Rd.
Romanian: Sanofi Malta Ltd. St.
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Romanian: Marea Britanie Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
English: HEXAL A/S, Kanalholmen 8-12, DK2650 Hvodovre, Denmark
Romanian: Danemarca HEXAL A/S, Kanalholmen 8-12, DK2650 Hvodovre, Denmark
English: Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
Romanian: Marea Britanie Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
English: 10 mg/ml oral drops, solution oral use
Romanian: 10 mg/ml picături orale, soluţie
English: Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Romanian: Luxemburg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Romanian: Marea Britanie Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4
English: Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Romanian: Luxemburg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Luxembourg Genthon BV Microweg, 22
Romanian: Luxemburg Genthon BV Microweg, 22
English: Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Romanian: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
English: Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia
Romanian: ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia
English: Czech Republic sanofi-aventis, s.r.o.
Romanian: Republica Cehă sanofi-aventis, s.r.o.
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Romanian: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
English: Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Romanian: SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Luxembourg Eurogenerics S.A. Esplanade Heysel, b22
Romanian: Luxemburg Eurogenerics S.A. Esplanade Heysel, b22
English: Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Romanian: MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Romanian: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: Rowex Ltd, Bantry, Co. Cork, Ireland
Romanian: Rowex Ltd, Bantry, Co.
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Romanian: Telecom Gardens Medialaan 40
English: Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
Romanian: LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano - Italy
English: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Romanian: Marea Britanie Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22
English: Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Romanian: Danemarca sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970
English: - via Messina 3820154 Milano Italy
Romanian: Teva Italia S.r.l. - via Messina 3820154 Milano Italy
English: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
Romanian: Marea Britanie Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
English: Plom 2-4, 5º Planta , Barcelona.
Romanian: MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º Planta , Barcelona.
English: Czech Republic Generics [UK] Ltd. Station Close
Romanian: Marea Britanie Generics [UK] Ltd. Station Close
English: Luxembourg Apotex Europe B.V. Darwinweg 20
Romanian: Luxemburg Apotex Europe B.V. Darwinweg 20
English: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Romanian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
English: Józefińska 2
Romanian: z o.o. ul. Józefińska 2
English: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Romanian: 92931 Paris La Défense Cedex FRANCE
English: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Romanian: Marea Britanie Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
English: C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
Romanian: TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
English: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
Romanian: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g. LT-09310 Vilnius Lithuania
English: Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Romanian: Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd.
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Romanian: Republica Slovacă sanofi-aventis Slovakia s.r.o. Einsteinova 24
English: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Romanian: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten comprimat efervescent
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Romanian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
English: INSOM 10 mg pezsgőtabletta effervescent tablet oral use
Romanian: INSOM 10 mg pezsgőtabletta comprimat efervescent
English: - Viale Bodio 37/b, 20158 Milano Italy
Romanian: ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, 20158 Milano Italy
English: Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Romanian: Marea Britanie ratiopharm GmbH Graf Arco Strasse 3
English: Czech Republic Vitabalans Oy Varastokatu 8
Romanian: Danemarca Vitabalans Oy Varastokatu 8
English: Heumann Pharma GmbH & Co. Generica KG
Romanian: Heumann Pharma GmbH & Co.
English: Insom effervescent tablet oral use
Romanian: Insom comprimat efervescent
English: LEK farmacevtska družba d.d.
Romanian: LEK farmacevtska družba d.d. Verovškova 57
English: Farma-Projekt Sp. z o.o.
Romanian: Farma-Projekt Sp.
English: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Romanian: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten comprimat efervescent
English: Turati 40, Milano - 20121 Italy
Romanian: Doc Generici S.r.l. Turati 40, Milano - 20121 Italy
English: Zolpidemtartraat ADOH 10 mg, bruistabletten effervescent tablet oral use
Romanian: Zolpidemtartraat ADOH 10 mg, bruistabletten comprimat efervescent
English: Stilnoct, tabletten 10 mg tablet oral use
Romanian: Stilnoct, tabletten 10 mg comprimat
English: ADORMA 5 mg filmom obalené tablety 5 mg
Romanian: ADORMA 5 mg filmom obalené tablety
English: Perluna 5 mg filmsko obožene tablete 5 mg
Romanian: Perluna 5 mg filmsko obožene tablete
English: Czech Republic SANDOZ s.r.o.
Romanian: SANDOZ s.r.o.
English: Zolpidem Sandoz 10 mg film-coated tablets
Romanian: Zolpidem Sandoz 10 mg filmcoated tablets
English: Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Romanian: Zolpidemtartraat Actavis 10 mg, tabletten comprimat
English: Šlandrova ulica 4
Romanian: Marea Britanie ALKALOID-INT d.o.o. Šlandrova ulica 4
English: Sanval 10 mg filmsko obožene tablete 10 mg
Romanian: Sanval 10 mg filmsko obožene tablete
English: Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Romanian: Takeda GmbH Byk-Gulden-Str.
English: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Romanian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Lunata 5 mg filmom obložene tablete 5 mg
Romanian: Lunata 5 mg filmom obložene tablete
English: Zolpeduar sublingual tablet sublingual use
Romanian: Zolpeduar comprimat sublingual
English: Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Romanian: Edluar 10 mg, tablet voor sublinguaal gebruik comprimat sublingual administrare sublinguală
English: Sanval 10 mg filmom obložene tablete 10 mg
Romanian: Sanval 10 mg filmom obložene tablete
English: EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Romanian: EDLUAR 10 mg nyelvalatti tabletta 10 mg comprimat sublingual administrare sublinguală
English: Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Romanian: Stilnoct 5mg fiilm-coated tablets 5 mg drajeu
English: Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Romanian: Zolpidemtartaat Actavis 5 mg, tabletten comprimat
English: Stilnoct 5mg Film-coated Tablets
Romanian: Stilnoct 5mg Film-coated Tablets 5 mg
English: ul.
Romanian: Co.
English: 2ª planta.
Romanian: Edif. Berlin. 2ª planta.
English: Zolpidem Tartrate 10mg tablets
Romanian: Zolpidem Tartrate 10mg tablets 10 mg
English: Croatia
Romanian: Republica Croaţia
English: Sanval 5 mg filmom obložene tablete 5 mg
Romanian: Sanval 5 mg filmom obložene tablete
English: Zolpidem Tartrate 5mg tablets
Romanian: Zolpidem Tartrate 5mg tablets 5 mg
English: Mondeal 10 mg - Filmtabletten
Romanian: Mondeal 10 mg - Filmtabletten 10 mg
English: Sanval 5 mg filmsko obložene tablete 5 mg
Romanian: Sanval 5 mg filmsko obložene tablete
English: Zolpidem "Hexal" - Filmtabletten
Romanian: Zolpidem "Hexal" - Filmtabletten 10 mg
English: Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Romanian: Edluar 5 mg, tablet voor sublinguaal gebruik comprimat sublingual administrare sublinguală
English: Lunata 10 mg filmom obložene tablete 10 mg
Romanian: Lunata 10 mg filmom obložene tablete
English: SANOFI-AVENTIS ROMÂNIA S.R.L.
Romanian: SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et.
English: Zolpidem Cinfa 10 mg Comprimidos 10 mg
Romanian: Zolpidem Cinfa 10 mg Comprimidos
English: Zolsana 5 mg coated tablets coated tablet oral use
Romanian: Zolsana 5 mg coated tablets drajeu
English: Zolpidem Aristo 10 mg Filmtabletten 10 mg
Romanian: Zolpidem Aristo 10 mg Filmtabletten
English: Zolpidem Tartrate 10mg, film-coated tablets
Romanian: Zolpidem Tartrate 10mg, filmcoated tablets
English: Zolpidem Tartrate 5mg, film-coated tablets
Romanian: Zolpidem Tartrate 5mg, filmcoated tablets
English: Stilnox 10 mg film-coated tablets
Romanian: Stilnox 10 mg film-coated tablets 10 mg
English: Verovskova 57
Romanian: LEK Pharmaceuticals d.d. Verovskova 57
English: EDLUAR 5 mg nyelvalatti tabletta sublingual tablet sublingual use
Romanian: EDLUAR 5 mg nyelvalatti tabletta 5 mg comprimat sublingual administrare sublinguală
English: Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Romanian: Zolpidem Sandoz 10 mg Filmtabletten
English: Zolpidem Hexal 10 mg Filmtabletten 10 mg
Romanian: Zolpidem Hexal 10 mg Filmtabletten
English: Zolpidem Tartrate Teva 10 mg Filmcoated Tablets
Romanian: Zolpidem Tartrate Teva 10 mg Film-coated Tablets
English: Zolpidem-CT 5 mg Filmtabletten
Romanian: Zolpidem-CT 5 mg Filmtabletten 5 mg
English: Edluar sublingual tablet sublingual use
Romanian: Edluar comprimat sublingual
English: Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
Romanian: Takeda GmbH 2 Byk-Gulden Strasse
English: Zoldem 10 mg film coated tablets
Romanian: Zoldem 10 mg film coated tablets 10 mg
English: Zolpidem Tartrate 10mg film-coated tablets
Romanian: Zolpidem Tartrate 10mg filmcoated tablets
English: ZOLPIDEM VITABALANS 10MG
Romanian: ZOLPIDEM VITABALANS 10MG 10 mg comprimat
English: Zolpidem AL 5 mg Filmtabletten
Romanian: Zolpidem STADA 5 mg Filmtabletten
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet sublingual use
Romanian: Edluar 10 mg Sublingualtabletten 10 mg comprimat sublingual
English: Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Romanian: Zolpidem-Actavis 10 mg Filmtabletten
English: Edluar 5 mg sublingual tablets sublingual tablet sublingual use
Romanian: Edluar 5 mg sublingual tablets comprimat sublingual
English: Stilnoct 10mg Film-coated Tablets
Romanian: Hypnogen 10 mg film-coated tablets
English: Zolsana 10 mg coated tablets coated tablet oral use
Romanian: Zolsana 10 mg coated tablets drajeu
English: Zolpidem dura 10 mg Filmtabletten 10 mg
Romanian: Zolpidem dura 10 mg Filmtabletten
English: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Romanian: Zolpidemtartraat ratiopharm 10 mg, tabletten comprimat
English: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Romanian: Zolpidemtartraat ratiopharm 5 mg, tabletten comprimat
English: Hypnogen 10 mg film-coated tablets 10 mg
Romanian: Stilnoct 10mg Film-coated Tablets 10 mg
English: 10 mg - Filmtabletten 10 mg
Romanian: Zoldem 10 mg - Filmtabletten 10 mg
English: Zolpidem STADA 5 mg Filmtabletten 5 mg
Romanian: Zolpidem AL 5 mg Filmtabletten 5 mg
English: Zolsana 5 mg filmom obložene tablete 5 mg
Romanian: Zolsana 5 mg filmom obložene tablete
English: effervescent tablet oral use
Romanian: comprimat efervescent
English: Zolpidem STADA 10 mg Filmtabletten 10 mg
Romanian: Zolpidem STADA 10 mg Filmtabletten
English: Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Romanian: Germania ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolpidem IPCA 10 mg Filmtabletten 10 mg
Romanian: Zolpidem IPCA 10 mg Filmtabletten
English: Zolsana 5 mg filmsko obložene tablete 5 mg
Romanian: Zolsana 5 mg filmsko obložene tablete
English: Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Romanian: Suedia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolnod 10mg film-coated tablets
Romanian: Zolnod 10mg film-coated tablets 10 mg
English: Edluar 5mg sublingual tablets sublingual tablet oral use
Romanian: Edluar 5mg sublingual tablets comprimat sublingual
English: Stilnoct tablet oral use
Romanian: Stilnoct comprimat
English: sublingual tablet sublingual use
Romanian: comprimat sublingual administrare sublinguală
English: SOMNOGEN 10 mg filmtabletta
Romanian: SOMNOGEN 10 mg filmtabletta 10 mg
English: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Romanian: Aliud Pharma GmbH Gottlieb-Daimler-Str.
English: Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Romanian: Finlanda ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Edluar 5 mg podjezične tablete sublingual tablet sublingual use
Romanian: Edluar 5 mg podjezične tablete 5 mg comprimat sublingual administrare sublinguală
English: Meda Pharma GmbH & Co. KG Benzstrasse 1
Romanian: KG Benzstrasse 1
English: Zolpi-Lich 10 mg Filmtabletten
Romanian: Zolpi-Lich 10 mg Filmtabletten 10 mg
English: Edluar 5 mg Sublingualtabletten sublingual tablet sublingual use
Romanian: Edluar 5 mg Sublingualtabletten 5 mg comprimat sublingual administrare sublinguală
English: The European Commission issued a decision on 5 October 2010.
Romanian: Comisia Europeană a emis o decizie la 5 octombrie 2010.
English: The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Romanian: Societatea a dorit recunoaşterea autorizaţiei în Bulgaria, Germania, Franţa, Irlanda şi Italia („statele membre în cauză”).
English: Daniela Melchiorri (Italy)
Romanian: Daniela Melchiorri (Italia)
English: Kristina Dunder (Sweden)
Romanian: Kristina Dunder (Suedia)
English: What is Norsed Combi D?
Romanian: Ce este Norsed Combi D?
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Romanian: Cu toate acestea, statele membre nu au putut ajunge la un acord, iar agenţia de reglementare în domeniul medicamentului din Suedia a sesizat în acest sens CHMP în vederea unui arbitraj la 29 aprilie 2010.
English: The grounds for the referral were concerns over the evidence provided of the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
Romanian: Motivele sesizării au fost reprezentate de preocupările legate de dovezile prezentate cu privire la eficacitatea acestui medicament combinat, valabilitatea afirmaţiilor că acest mod de asociere a substanţelor active va aduce beneficii pacienţilor în comparaţie cu substanţele active individuale şi valabilitatea afirmaţiilor că medicamentul ameliorează complianţa (capacitatea pacienţilor de a adera la tratament).
English: Blocking the action of these cells leads to less bone loss.
Romanian: Blocarea acţiunii acestor celule determină o mai mică pierdere a masei osoase.
English: 20 May 2010
Romanian: 20 mai 2010
English: It is used to reduce the risk of fractures (in the hip and spine.
Romanian: Acesta se utilizează pentru a reduce riscul de fracturi (ale şoldului şi coloanei vertebrale).
English: Sanofi-aventis S.p.A. submitted Norsed Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006.
Romanian: Sanofi-aventis S.p.A. a depus o cerere pentru recunoaşterea reciprocă a Norsed Combi D în baza autorizaţiei iniţiale acordate de Suedia la 3 octombrie 2006.
English: Why was Norsed Combi D reviewed?
Romanian: De ce a fost evaluat Norsed Combi D?
English: Norsed Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Romanian: Norsed Combi D se utilizează pentru tratamentul osteoporozei (o boală în care oasele devin fragile) la femeile care au trecut prin menopauză.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Romanian: Acesta împiedică acţiunea osteoclastelor, celulele care sunt implicate în descompunerea ţesutului osos.
English: 5 October 2010
Romanian: 5 octombrie 2010
English: The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Romanian: Substanţele active din granulele efervescente asigură calciu şi vitamina D, care sunt necesare pentru formarea normală a oaselor.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Norsed Combi D outweigh its risks, and therefore the marketing authorisation for Norsed Combi D should be granted in all concerned Member States.
Romanian: Pe baza evaluării datelor disponibile în prezent şi a dezbaterii ştiinţifice din cadrul comitetului, CHMP a concluzionat că beneficiile Norsed Combi D sunt mai mari decât riscurile asociate şi, prin urmare, autorizaţia de punere pe piaţă pentru Norsed Combi D trebuie acordată în toate statele membre în cauză.
English: Norsed Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol.
Romanian: Norsed Combi D este un medicament care conţine trei substanţe active, risedronat de sodiu, carbonat de calciu şi colecalciferol.
English: It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol.
Romanian: Acesta constă în comprimate care conţin 35 mg risedronat de sodiu, împreună cu pliculeţe de granule efervescente care conţin 1 000 mg calciu sub formă de carbonat de calciu şi 880 UI colecalciferol.
English: The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Romanian: Substanţa activă din comprimate, risedronatul de sodiu, este un bifosfonat.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Norsed Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Norsed Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in other Member States of the EU.
Romanian: Comitetul pentru produse medicamentoase de uz uman (CHMP) al agenţiei a concluzionat că beneficiile Norsed Combi D sunt mai mari decât riscurile asociate şi că autorizaţia de punere pe piaţă acordată în Suedia poate fi recunoscută în alte state membre ale UE.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Romanian: Concentraţia Forma farmaceutică Calea de administrare Ambalajul primar Mărimea ambalajului
English: These measures should help to protect the environment.
Romanian: Aceste măsuri vor ajuta la protejarea mediului înconjurător.
English: Their effect is essentially confined to rapidly dividing organisms.
Romanian: Efectul lor este limitat esenţial la organismele cu divizare rapidă.
English: Efficacy studies under field conditions have not been conducted.
Romanian: Nu au fost realizate studii de eficacitate în condiţii de teren.
English: Treat all the birds in the affected flock.
Romanian: Trataţi toate păsările din grupul afectat.
English: One additional yearly periodic safety update report (PSUR) is required, and thereafter PSURs shall be submitted at three-yearly intervals, unless otherwise required.
Romanian: Este obligatoriu un raport periodic de siguranță actualizat (PSUR) anual suplimentar, iar ulterior PSUR-urile vor fi depuse la intervale de trei ani, cu excepția cazului în care cerințele impun altceva.
English: In order to obtain the correct dose, the concentration of Aivlosin has to be adjusted accordingly.
Romanian: Pentru a obţine o dozare corectă, concentraţia de Aivlosin trebuie ajustată corespunzător.
English: OTHER CONDITIONS:
Romanian: • ALTE CONDIŢII:
English: Bacteria can develop resistance to antimicrobial substances.
Romanian: Bacteriile pot dezvolta rezistenţă la substanţele antimicrobiene.
English: Wash contaminated skin.
Romanian: Spălaţi pielea contaminată.
English: Do not release pheasants for at least two days after the end of medication.
Romanian: Nu eliberaţi fazanii inca cel puţin două zile după încheierea medicaţiei.
English: Major incompatibilities:
Romanian: Incompatibilităţi majore:
English: Store in the original container.
Romanian: A se păstra în containerul original.
English: The tmax for tylvalosin is about 2.2 hours; the terminal half-life for the elimination is approximately 2.2 hours.
Romanian: Valoarea tmax pentru tilvalozină este de aproximativ 2,2 ore; timpul terminal de înjumătăţire prin eliminare este de aproximativ 2,2 ore.
English: Overdose (symptoms, emergency procedures, antidotes):
Romanian: Supradozare (simptome, proceduri de urgenţă, antidoturi):
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Romanian: Întrebaţi veterinarul cum să eliminaţi medicamentele de care nu mai aveţi nevoie.