FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you have porphyria (a liver enzyme disease)
Lithuanian: • Sergate porfirija (kepenų fermento sutrikimas).
English: 6.6 Special precautions for disposal
Lithuanian: 6.6 Specialūs reikalavimai atliekoms tvarkyti ir vaistiniam preparatui ruošti
English: Vulvovaginal mycotic infection
Lithuanian: Tromboembolinės venų ligos
English: • If you become pregnant
Lithuanian: • Jei pastojote.
English: • Swelling or discomfort of the abdomen (stomach)
Lithuanian: • Pilvo pūtimas, diskomforto jausmas pilve (skrandyje).
English: • If you have a blood clot (like deep vein thrombosis or lung embolism) or previously have had a blood clot without obvious cause, e.g. in connection with surgery or pregnancy
Lithuanian: • Jeigu Jums buvo susidarę kraujo krešuliai kojų arba plaučių kraujagyslėse arba yra padidėjusi jų susidarymo rizika (giliųjų venų trombozė arba plaučių arterijos tromboembolija).
English: • Migraine (see “Stop taking Activelle” in section 2)
Lithuanian: 2 skyriuje „Būklės, kurioms pasireiškus reikia nedelsiant nutraukti Activelle vartojimą“).
English: What Activelle contains
Lithuanian: KAS YRA ACTIVELLE IR NUO KO JIS VARTOJAMAS
English: Effects on the skin
Lithuanian: Kojų mėšlungis
English: Vulvovaginal mycotic infection, see also “Reproductive system and breast disorders
Lithuanian: Makšties mikozė arba lytinių organų kandidozė, taip pat žr.
English: • Dizziness
Lithuanian: • Pykinimas.
English: • Hepatobilitary disorders: Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis re-occurrence
Lithuanian: • Kepenų, tulžies pūslės ir latakų sutrikimai: cholecistitas, tulžies akmenligė, jos pasunkėjimas arba atsinaujinimas.
English: Activelle 0,5 mg/0,1 mg comprimé pelliculé
Lithuanian: Activelle 0,5 mg/ 0,1 mg comprimidos
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Lithuanian: PARDAVIMO (IŠDAVIMO) TVARKA [Pildoma, kaip patvirtinta šalyje narėje]
English: Treatment should not be restarted until the woman is completely mobilised.
Lithuanian: PHT galima atnaujinti tik tuomet, kai pacientė vėl galės vaikščioti.
English: • Liver disorders (e.g. liver adenoma)
Lithuanian: • Kepenų ligos (pvz., kepenų adenoma).
English: Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Lithuanian: 0,5 mg estradiolio (hemihidrato pavidalu) ir 0,1 mg noretisterono acetato
English: Other conditions
Lithuanian: PAGRINDAS
English: • Painful swelling in your leg
Lithuanian: • staigus skausmas krūtinėje,
English: • Feeling sick
Lithuanian: Pilvo skausmas
English: Fluid retention, see also “General disorders and administration site conditions
Lithuanian: “Bendrieji sutrikimai ir vartojimo vietos pažeidimai”
English: Estradiol 0.5 mg (as hemihydrate) and norethisterone acetate 0.1 mg.
Lithuanian: 0,5 mg estradiolio (hemihidrato pavidalu) ir 0,1 mg noretisterono acetato.
English: What Activelle is and what it is used for Before you take Activelle How to use Activelle Possible side effects How to store Activelle Further information
Lithuanian: Kas yra Activelle ir nuo ko jis vartojamas 2.
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
Lithuanian: , krūtinės angina, miokardo infarktas).
English: It is estimated that for women who use conjugated oestrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years.
Lithuanian: Nustatyta, kad 50-59 metų moterų, penkerius metus vartojusių konjuguotų estrogenų ir medroksiprogesterono acetato, grupėje papildomų insulto atvejų buvo nuo 0 iki 3 (vidutiniškai 1) iš 1000.
English: Coronary artery disease (CAD)
Lithuanian: • Venų tromboembolinės ligos, t.
English: Estonia - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finland - Activelle 0,5 mg/0,1 mg tabl.
Lithuanian: Islandija - Activelle low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Airija - Activelle low 0.5mg/0.1mg film-coated tablets Italija - Activelle
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Lithuanian: Vienoje plėvele dengtoje tabletėje yra: 0,5 mg estradiolio (hemihidrato pavidalu), 0,1 mg noretisterono acetato.
English: • If you have or have had a liver disorder and your liver tests have not returned to normal
Lithuanian: • Sergate arba praeityje sirgote kepenų ligomis ir kepenų veiklos rodikliai išliko pakitę.
English: • Cholelithiasis
Lithuanian: • Spuogai.
English: Av. do Forte, nº 3 - Parque Suécia, Edifício.
Lithuanian: do Forte, nº 3 - Parque Suécia, Edifício.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Lithuanian: Pavadinimų, farmacinių formų, vaistų stiprumo, vartojimo būdo, rinkodaros teisės turėtojų valstybėse narėse sąrašas
English: Via Ponte della Fabbrica, 3/a, Abano Terme, Padova - 35031
Lithuanian: Via Ponte della Fabbrica, 3/a, Abano Terme, Padova - 35031 Italy
English: Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Lithuanian: TEVA PHARMA BELGIUM NV Laarstraat 16
English: Alameda da Beloura, Edifício 1, 2ºEscritório 15
Lithuanian: Alameda da Beloura, Edifício 1, 2º - Escritório 15
English: Co. Tipperary Ireland
Lithuanian: Tipperary Ireland
English: EN6 1TL Hertfordshire - Potters Bar United Kingdom
Lithuanian: EN6 1TL Hertfordshire - Potters Bar
English: Sweden sanofi-aventis AB Box 14142
Lithuanian: Švedija sanofi-aventis AB Box 14142
English: 1990-095 Lisboa
Lithuanian: 1990-095 Lisboa Portugal
English: 1526 Ljubljana Slovenia
Lithuanian: 1526 Ljubljana
English: Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Lithuanian: Latvija sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
English: Novo Mesto Smarjeska cesta 6.
Lithuanian: Krka d.d. Novo Mesto Smarjeska cesta 6.
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Lithuanian: Rua João de Deus, 19 2700-487 Amadora Portugal
English: Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Lithuanian: Danija sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
English: 81829 München
Lithuanian: 81829 München Germany
English: Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Lithuanian: Triados 36, Palaio Faliro 17562
English: Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
Lithuanian: Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS
English: Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Lithuanian: Austrija sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
English: Luxembourg MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Lithuanian: Liuksemburgas MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
English: Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Lithuanian: Austrija ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
English: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Lithuanian: Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
English: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Lithuanian: Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
English: Marszałka J. Piłsudskiego 5 95-200 Pabianice
Lithuanian: Piłsudskiego 5 95-200 Pabianice Poland
English: Eurogenerics S.A. Esplanade Heysel, b22 1020 Bruxelles Belgium
Lithuanian: Esplanade Heysel, b22 1020 Bruxelles Belgium
English: Luxembourg Apotex Europe B.V. Darwinweg 20
Lithuanian: Liuksemburgas Apotex Europe B.V. Darwinweg 20
English: LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid).
Lithuanian: Ronda de Valdecarrizo, 6, Tres Cantos (Madrid).
English: Synthon B.V.
Lithuanian: Synthon B.
English: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Lithuanian: Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
English: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C7.3 e 7.4
Lithuanian: João II, Lote 1.06.2.2 C - 7.3 e 7.4
English: Luxembourg MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Lithuanian: Liuksemburgas MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Luxembourg SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Lithuanian: Liuksemburgas SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Luxembourg Genthon BV Microweg, 22
Lithuanian: Liuksemburgas Genthon BV Microweg, 22
English: Belgium MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
Lithuanian: MEDA PHARMA Chaussee de la Hulpe 166 1170 Watermael-Boitsfort Belgium
English: Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
Lithuanian: SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19 1831 Diegem
English: Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
Lithuanian: Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
English: Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Lithuanian: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
English: Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Lithuanian: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Lithuanian: Telecom Gardens Medialaan 40
English: Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia
Lithuanian: , Maksimirska 120, Zagreb, 1000, Croatia
English: Actavis B.V.
Lithuanian: Actavis B.
English: FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid).
Lithuanian: Aragoneses, 2, Alcobendas (Madrid).
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark
Lithuanian: Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
English: Teva Pharma B. V. Computerweg 10
Lithuanian: V. Computerweg 10
English: Centrafarm B.V.
Lithuanian: Centrafarm B.
English: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Lithuanian: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
English: ADOH B.V.
Lithuanian: ADOH B.
English: Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Lithuanian: Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul.
Lithuanian: Pabianickie Zakłady Farmaceutyczne Polfa S.A.
English: B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
Lithuanian: 44B Sector 3, Bucureşti, România
English: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Lithuanian: Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Lithuanian: Slovakijos Respublika sanofi-aventis Slovakia s.r.o.
English: 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Lithuanian: 92931 Paris La Défense Cedex FRANCE
English: RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.
Lithuanian: C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.
English: Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Lithuanian: Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd.
English: Meda Pharma B.V.
Lithuanian: Meda Pharma B.
English: Czech Republic sanofi-aventis, s.r.o.
Lithuanian: Čekijos Respublika sanofi-aventis, s.r.o.
English: Genfarma B.V.
Lithuanian: Genfarma B.
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Lithuanian: Nyderlandai ratiopharm Nederland B.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main Germany
Lithuanian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
English: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Lithuanian: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten
English: MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano - Italy
Lithuanian: , Viale brenta 18, 20139 Milano - Italy
English: McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Lithuanian: McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36
English: VULM CZ, a.s. Olivova 1888 Ricany
Lithuanian: Olivova 1888 Ricany
English: ZOLPIDEM-RATIOPHARM 10 MG 10 mg
Lithuanian: ZOLPIDEM-RATIOPHARM 10 mg
English: Czech Republic MEDA Pharma s.r.o.
Lithuanian: MEDA Pharma s.r.o.
English: UAB „SANOFI-AVENTIS LIETUVA“ A. Juozapavičiaus 6/2 g.
Lithuanian: UAB „SANOFI-AVENTIS LIETUVA“ A.
English: Belgium Eurogenerics S.A. Esplanade Heysel, b22
Lithuanian: Esplanade Heysel, b22
English: 110 00 Prague 10
Lithuanian: Kodaňská 1441/46 110 00 Prague 10
English: PHARMAGENUS, S.A. Avda.
Lithuanian: PHARMAGENUS, S.A.
English: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Lithuanian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Šlandrova ulica 4
Lithuanian: Swensweg 5
English: Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Lithuanian: Vokietija neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str.
English: Heumann Pharma GmbH & Co. Generica KG
Lithuanian: Heumann Pharma GmbH & Co.
English: SANDOZ FARMACÉUTICA, S.A. Avda.
Lithuanian: SANDOZ FARMACÉUTICA, S.A.
English: Farma-Projekt Sp. z o.o.
Lithuanian: Farma-Projekt Sp.
English: ADORMA 5 mg filmom obalené tablety 5 mg
Lithuanian: ADORMA 5 mg filmom obalené tablety
English: Czech Republic Takeda GmbH Byk-Gulden-Str. 2
Lithuanian: Takeda GmbH Byk-Gulden-Str.
English: Stilnoct, tabletten 10 mg tablet oral use
Lithuanian: Stilnoct, tabletten 10 mg
English: ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona.
Lithuanian: Osi, 7-9 Barcelona.
English: ITALFARMACO S.p.A. Viale Fulvio Testi 330, 20126 Milano, Italy
Lithuanian: Viale Fulvio Testi 330, 20126 Milano, Italy
English: Italfarmaco S.p.A. Viale Fulvio 330 20126 Milano Italy
Lithuanian: Viale Fulvio 330 20126 Milano Italy
English: Actavis Deutschland GmbH & Co.KG Willy-Brandt-Allee 2
Lithuanian: Willy-Brandt-Allee 2
English: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Lithuanian: Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten
English: Sanval 10 mg filmsko obožene tablete 10 mg
Lithuanian: Sanval 10 mg filmsko obožene tablete
English: Czech Republic SANDOZ s.r.o.
Lithuanian: SANDOZ s.r.o.
English: LEK farmacevtska družba d.d.
Lithuanian: LEK farmacevtska družba d.d. Verovškova 57
English: Zolpidemtartraat ADOH 10 mg, bruistabletten effervescent tablet oral use
Lithuanian: Zolpidemtartraat ADOH 10 mg, bruistabletten
English: tablet oral use
Lithuanian: Poliežuvinė tabletė
English: Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Lithuanian: Edluar 5 mg, tablet voor sublinguaal gebruik
English: Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Lithuanian: Edluar 10 mg, tablet voor sublinguaal gebruik
English: Zolpidem "Hexal" - Filmtabletten
Lithuanian: Zolpidem "Hexal" - Filmtabletten 10 mg
English: Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Lithuanian: Stilnoct 5mg fiilm-coated tablets
English: Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Lithuanian: Zolpidemtartraat Actavis 10 mg, tabletten
English: Sanval 10 mg filmom obložene tablete 10 mg
Lithuanian: Sanval 10 mg filmom obložene tablete
English: Lunata 10 mg filmom obložene tablete 10 mg
Lithuanian: Lunata 10 mg filmom obložene tablete
English: Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Lithuanian: Edluar 10 mg Sublingualtabletten 10 mg
English: Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Lithuanian: Zolpidemtartaat Actavis 5 mg, tabletten
English: Zolsana 5 mg coated tablets coated tablet oral use
Lithuanian: Zolsana 5 mg coated tablets
English: Zolpidem-CT 5 mg Filmtabletten
Lithuanian: Zolpidem-CT 5 mg Filmtabletten 5 mg
English: Takeda GmbH 2 Byk-Gulden Strasse 78467 Konstanz Germany
Lithuanian: Takeda GmbH 2 Byk-Gulden Strasse
English: Zolpidem-Actavis 10 mg Filmtabletten 10 mg
Lithuanian: Zolpidem-Actavis 10 mg Filmtabletten
English: Zolpidem Sandoz 10 mg Filmtabletten 10 mg
Lithuanian: Zolpidem Sandoz 10 mg Filmtabletten
English: G.L.
Lithuanian: L.
English: Zoldem 10 mg film coated tablets
Lithuanian: Zoldem 10 mg film coated tablets 10 mg
English: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Lithuanian: Aliud Pharma GmbH Gottlieb-Daimler-Str.
English: Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Lithuanian: Švedija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Luxembourg Eurogenerics S.A. Esplanade Heysel, b22
Lithuanian: Liuksemburgas Eurogenerics S.A.
English: United Kingdom ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Lithuanian: Jungtinė Karalystė ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Lithuanian: Vokietija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: Zolsana 5 mg filmsko obložene tablete 5 mg
Lithuanian: Zolsana 5 mg filmsko obložene tablete
English: Zolsana 5 mg filmom obložene tablete 5 mg
Lithuanian: Zolsana 5 mg filmom obložene tablete
English: Zolsana 10 mg coated tablets coated tablet oral use
Lithuanian: Zolsana 10 mg coated tablets
English: Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
Lithuanian: Zolpidemtartraat ratiopharm 5 mg, tabletten
English: Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Lithuanian: Zolpidemtartraat ratiopharm 10 mg, tabletten
English: Meda Pharma GmbH & Co. KG Benzstrasse 1
Lithuanian: KG Benzstrasse 1
English: Finland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Lithuanian: Suomija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany
Lithuanian: 5 27472 Cuxhaven Germany
English: The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Lithuanian: Bendrovė siekė rinkodaros teisės pripažinimo Bulgarijoje, Vokietijoje, Prancūzijoje, Airijoje ir Italijoje (susijusiose valstybėse narėse).
English: Kristina Dunder (Sweden)
Lithuanian: Kristina Dunder (Švedija)
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Lithuanian: Iš dalies pakeistos Direktyvos 29 straipsnyje numatytos procedūros rezultatai
English: Daniela Melchiorri (Italy)
Lithuanian: Daniela Melchiorri (Italija)
English: The European Commission issued a decision on 5 October 2010.
Lithuanian: Europos Komisija sprendimą priėmė 2010 m.
English: Procedure start date:
Lithuanian: Procedūros pradžios data:
English: EMA/CHMP/405858/2010 rev.1 EMEA/H/A-29/1273
Lithuanian: spalio 5 d EMA/CHMP/405858/2010 rev.1 EMEA/H/A-29/1273
English: What is Norsed Combi D?
Lithuanian: Kas yra Norsed Combi D?
English: Why was Norsed Combi D reviewed?
Lithuanian: Kodėl Norsed Combi D buvo peržiūrėtas?
English: 20 May 2010
Lithuanian: gegužės 20 d.
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).
Lithuanian: Kreipimosi procedūra pradėta kilus abejonėms dėl pateiktų šio vaistinių preparatų derinio veiksmingumo įrodymų ir dėl teiginių, kad taip vartojamų veikliųjų medžiagų pacientams teikiama nauda yra didesnė nei vartojamų po vieną ir kad vartojant šį vaistą, griežčiau laikomasi vaistų vartojimo reikalavimų (pacientai geriau laikosi gydymo nurodymų).
English: 5 October 2010
Lithuanian: spalio 5 d.
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.
Lithuanian: Atsižvelgdamas į šiuo metu turimų duomenų vertinimą ir komitete įvykusią mokslinę diskusiją, CHMP padarė išvadą, kad Norsed Combi D teikiama nauda yra didesnė už jo keliamą riziką, todėl reikėtų suteikti Norsed Combi D rinkodaros teisę visose susijusiose valstybėse narėse.
English: Co-rapporteur:
Lithuanian: Pranešėjos padėjėja:
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.
Lithuanian: Norsed Combi D skiriamas osteoporoze (liga, kuri lemia kaulų trapumą) sergančioms moterims po menopauzės.
English: Blocking the action of these cells leads to less bone loss.
Lithuanian: Slopinant šių ląstelių veikimą, sunyksta mažiau kaulinio audinio.
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.
Lithuanian: Bendrovė „Sanofi-aventis S.p.A“ pateikė paraišką dėl Norsed Combi D rinkodaros teisės suteikimo pagal savitarpio pripažinimo procedūrą, remdamasi 2006 m.
English: Norsed Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol.
Lithuanian: Norsed Combi D yra vaistas, kuriame yra trijų veikliųjų medžiagų: natrio rizedronato, kalcio karbonato ir kolekalciferolio.
English: The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Lithuanian: Putojančiose granulėse yra veikliųjų medžiagų kalcio ir vitamino D, kurių reikia normaliam kauliniam audiniui formuotis.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Lithuanian: Jis stabdo osteoklastų (ląstelių, kurios susijusios su kaulinio audinio irimu) veikimą.
English: It is used to reduce the risk of fractures (in the hip and spine.
Lithuanian: Vaistas vartojamas siekiant mažinti klubo kaulų ir stuburo lūžių pavojų.
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.
Lithuanian: Švedijos vaistų kontrolės agentūra perdavė klausimą svarstyti CHMP pagal arbitražo procedūrą.
English: The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Lithuanian: Tabletėse esanti veiklioji medžiaga natrio rizedronatas yra bifosfonatas.
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.
Lithuanian: Vaistas sudarytas iš tablečių, kuriose yra 35 mg natrio rizedronato, ir maišelių su putojančiomis granulėmis, kuriose yra 1 000 mg kalcio (kalcio karbonato forma) ir 880 tarptautinių vienetų (TV) kolekalciferolio.
English: Questions and answers on Norsed Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules) EMA/CHMP/405858/2010 rev.
Lithuanian: Klausimai ir atsakymai dėl Norsed Combi D ir susijusių pavadinimų (natrio rizedronato 35 mg tablečių / kalcio ir kolekalciferolio 1 000 mg / 880 TV putojančių granulių) EMA/CHMP/405858/2010 rev.
English: Questions and answers on Norsed Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules)
Lithuanian: Klausimai ir atsakymai dėl Norsed Combi D ir susijusių pavadinimų (natrio rizedronato 35 mg tablečių / kalcio ir kolekalciferolio 1 000 mg / 880 TV putojančių granulių)