FrancophonIA/ELRC3.0 huggingface dataset:
English: What is happening with Abilify for the treatment of other diseases?
Icelandic: Hvad vil der ske med brugen af Abilify til behandling af andre sygdomme?
English: What was Abilify expected to be used for?
Icelandic: Hvad forventedes Abilify anvendt til?
English: What is Abilify?
Icelandic: Hvad er Abilify?
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Icelandic: Det aktive stof i Abilify, aripiprazol, er et antipsykotisk lægemiddel.
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Abilify's product information.
Icelandic: Udvalget besluttede dog, at dataene kunne være vigtig viden for sundhedspersoner, og anbefalede, at de blev indføjet i produktinformationen for Abilify.
English: Although the relapse rate with Abilify in 13 and 14 year olds was similar to the rate in older children (21% and 19% respectively), the number of patients in the main study was too small to draw firm conclusions in the younger group.
Icelandic: Selvom recidivraten (dvs. forekomsten af tilbagevendende symptomer) ved brug af Abilify hos 13-14årige svarede til recidivraten hos ældre børn (21 % mod 19 %), var antallet af børn i hovedundersøgelsen for lavt til at drage sikre konklusioner i denne gruppe.
English: For schizophrenia it is currently approved only for patients aged 15 years and over.
Icelandic: I indikationen skizofreni er det i øjeblikket kun godkendt til patienter i alderen 15 år og derover.
English: The study investigated how effectively Abilify prevented a relapse of their symptoms.
Icelandic: I undersøgelsen så forskerne nærmere på, hvor effektivt Abilify var til at forhindre, at de unges symptomer vendte tilbage.
English: However, the CHMP noted that schizophrenia is rare in younger patients and that including the data in Abilify's product information could help the healthcare professionals who manage them.
Icelandic: CHMP bemærkede imidlertid, at skizofreni forekommer sjældent hos yngre patienter, og at tilføjelsen af dataene i Abilifys produktinformation kunne hjælpe de sundhedspersoner, der behandler yngre patienter.
English: Abilify is a medicine for treating schizophrenia and bipolar disorder.
Icelandic: Abilify er et lægemiddel til behandling af skizofreni og bipolar lidelse.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Abilify.
Icelandic: Der er ingen konsekvenser af udfaldet af denne ansøgning for patienter, der deltager i igangværende eller kommende kliniske undersøgelser med Abilify.
English: On 15 September 2016, the Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of Abilify in schizophrenia to adolescents aged 13 and 14 years.
Icelandic: Udvalget for Lægemidler til Mennesker (CHMP) afsluttede den 15. september 2016 gennemgangen af en ansøgning om udvidelse af brugen af Abilify ved skizofreni til at omfatte unge i alderen 13-14 år.
English: The CHMP therefore concluded that Abilify could not be approved for schizophrenia in 13 and 14 year olds on the basis of these data.
Icelandic: CHMP konkluderede derfor, at Abilify ikke kunne godkendes til behandling af skizofreni hos 13-14-årige børn på grundlag af disse data.
English: There are no consequences on the use of Abilify in bipolar disorder or its currently approved use in patients with schizophrenia aged 15 years and over.
Icelandic: Der er ingen konsekvenser for brugen af Abilify til behandling af bipolar lidelse eller for den allerede godkendte brug hos patienter med skizofreni i alderen 15 år og derover.
English: Abilify contains the active substance aripiprazole.
Icelandic: Det indeholder det aktive stof aripiprazol.
English: The company that markets Abilify applied for it to be used to treat schizophrenia in patients aged 13 years and over.
Icelandic: Virksomheden, der markedsfører Abilify, ansøgte om at få det godkendt til behandling af skizofreni hos patienter i alderen 13 år og derover.
English: Application to extend use of Abilify in schizophrenia to 13 and 14 year olds
Icelandic: Ansøgning om udvidelse af brugen af Abilify ved skizofreni til at omfatte 13-14-årige
English: How does Abilify work?
Icelandic: Hvordan virker Abilify?
English: PHARMACEUTICALS SA EVROU 4 AND MESSINIAS 2
Icelandic: EVROU 4 AND MESSINIAS
English: IAMATICA MON. LTD CHALANDRIOU 6A AGIA PARASKEVI
Icelandic: LTD CHALANDRIOU 6A AGIA PARASKEVI
English: Novartis Norge AS, Postboks 4284 Nydalen
Icelandic: Novartis Norge AS, Postboks 4284
English: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 OriggioVARESE
Icelandic: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 Origgio
English: MEDHEL HELLAS PHARMACEUTICAL INDUSTRY
Icelandic: MEDHEL HELLAS PHARMACEUTICAL
English: 12th Km National Highway
Icelandic: A.E.B.E. 12th Km National Highway
English: PHARMACEUTICALS 1ST KM PAIANIASMARKOPOULOU AVENUE PAIANIA 19002
Icelandic: DOCTUM PHARMACEUTICALS 1ST KM PAIANIASMARKOPOULOU AVENUE PAIANIA 19002
English: Rua Alfredo da Silva, 16 2610-016 Amadora Portugal
Icelandic: Rua Alfredo da Silva, 16 2610-016
English: Wincentego st. Pola 21 58-500, Jelenia Góra, Poland
Icelandic: 58-500, Jelenia Góra, Poland
English: Novartis Hungária Kft. Bartók Béla út 43-47.
Icelandic: Bartók Béla út 43-47.
English: VOTANIA SA PEGASSOU 18
Icelandic: PEGASSOU 18
English: ALPHA GENERICS THERAPY AEBEF KORYTSAS 13
Icelandic: ALPHA GENERICS THERAPY AEBEF
English: FARMEDIA SA ATHINAS 22 AND APOLLONOS GERAKAS ATTIKIS
Icelandic: FARMEDIA SA ATHINAS 22 AND APOLLONOS
English: PHARMACEUTICALS SA GOUNARI 150, GLYFADA 16674
Icelandic: GOUNARI 150, GLYFADA 16674
English: Germany mibe GmbH Arzneimittel Münchener Str. 15
Icelandic: Þýskaland mibe GmbH Arzneimittel Münchener Str. 15
English: ANFARM HELLAS PERIKLEOUS 53-57 ATHENS
Icelandic: ANFARM HELLAS PERIKLEOUS 53-57
English: LEOVAN M. LEON AND CO
Icelandic: LEOVAN M. LEON AND CO MENANDROU 54
English: PHARMACEUTICALS LTD. 425 Irakliou Avenue, 14122 Atena, Grecia
Icelandic: 425 Irakliou Avenue, 14122 Atena, Grecia
English: Slovak Republic ratiopharm International GmbH
Icelandic: Slóvakía ratiopharm International GmbH
English: 18th km Athens-Lamia National Road 146 71 Nea Erythrea Greece
Icelandic: Vianex SA, Tatoiou street, 18th km Athens-Lamia National Road 146 71 Nea Erythrea Greece
English: MEDIMAR SA MEDICINES COSMETICS KIFISSIAS 13
Icelandic: MEDIMAR SA MEDICINES COSMETICS
English: 200IU in 1ml
Icelandic: 200 a.e. in 1ml
English: PHARM LTD ARKOLEON 11
Icelandic: J.A. PHARM LTD ARKOLEON 11
English: 635 00 Brno Czech republic
Icelandic: 635 00 Brno
English: Calcitonin-ratiopharm Nasenspray
Icelandic: Calcitoninratiopharm Nasenspray
English: Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
Icelandic: Przedsiębiorstwo Farmaceutyczne Jelfa S.A. Wincentego st.
English: Via Licinio 11, Erba(Como)
Icelandic: Lisapharma S.p.A. Via Licinio 11, Erba(Como)
English: Novartis Finland Oy Metsänneidonkuja 10 02130 Espoo Finland
Icelandic: Oy Metsänneidonkuja 10 02130
English: Osteodon 200 IU.
Icelandic: Osteodon 200 I.U.
English: SANOFI AVENTIS, S.A.Josep Plá, 2
Icelandic: SANOFI AVENTIS, S.A.Josep Plá, 2 Barcelona 08019
English: Zambon France 13 rue René Jacques 92138 Issy les Moulineaux CedexFrance
Icelandic: Zambon France 13 rue René Jacques 92138
English: LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA Via Licinio, 11
Icelandic: LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA
English: ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3Edificio Suécia III, Piso 1
Icelandic: Avenida do Forte, 3 - Edificio Suécia III,
English: Calcitonin-ratiopharm 200 Nasal
Icelandic: Calcitoninratiopharm 200 Nasal
English: ALMIRALL, S.A.Ronda General Mitre, 151
Icelandic: ALMIRALL, S.A.Ronda General Mitre, 151 08022 Barcelona
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Icelandic: Viðauki I Listi yfir heiti, lyfjaform, styrkleika lyfsins/lyfjanna, íkomuleið(ir), markaðsleyfishafa í aðildarlöndunum
English: Laboratoire Pharmy II Strategy center 26 rue des Gaudines 78100 Saint Germain en Laye - France
Icelandic: II Strategy center 26 rue des Gaudines 78100
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Icelandic: Þýskaland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: Gentsesteenweg 615 1080 Brussels Belgium
Icelandic: Nycomed Belgium sca/cva Gentsesteenweg 615 1080 Brussels Belgium
English: Calcitonin 'Novartis' 200 I.E. - Nasalspray
Icelandic: Calcitonin 'Novartis' 200 I.E.
English: FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain
Icelandic: NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 Barcelona 08013
English: PHARMACEUTICALS SA KIFISSOU AVENUE 122 PERISTERI 1231
Icelandic: KIFISSOU AVENUE 122 PERISTERI 1231
English: EVAGGELOS KALOFOLIAS IAPHARM MENANDROU 54
Icelandic: EVAGGELOS KALOFOLIAS IAPHARM
English: Calcitonin 'Novartis' 100 I.E. - Nasalspray
Icelandic: Calcitonin 'Novartis' 100 I.E.
English: 41 Chalton street, London, NW1 1JD, United Kingdom
Icelandic: VERISFIELD (UK) LTD, U.K. 41 Chalton street, London, NW1 1JD, United Kingdom
English: Solução para Pulverização Nasal
Icelandic: UI solución para pulverización nasal
English: Lagoas Park, Edifício 10
Icelandic: Laboratórios Pfizer, Lda. Lagoas Park, Edifício 10
English: Novartis FarmaProdutos Farmacêuticos, S.A.
Icelandic: Novartis Farma - Produtos Farmacêuticos, S.A.
English: ROTTAPHARM HELLAS ACHAIAS AND TRIZOINIAS NEA KIFISSIA 14564
Icelandic: HELLAS ACHAIAS AND TRIZOINIAS NEA KIFISSIA 14564
English: Av. José MalhoaEdifício Malhoa Plaza nº piso-escritório 2.2 1070-325 Lisboa Portugal
Icelandic: José Malhoa - Edifício Malhoa Plaza nº 2, piso-escritório 2.2
English: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14 03006 Alicante
Icelandic: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14
English: UCB Pharma GmbH Geiselbergstraße 1719/2, 5.Stock 1110 Wien, Austria
Icelandic: UCB Pharma GmbH Geiselbergstraße 17-19/2, 5.Stock
English: GABRIEL HEALTH PHARMACEUTICALS LTD GRIG.
Icelandic: PHARMACEUTICALS LTD GRIG.
English: PIKERMI ATTIKIS 19009
Icelandic: MARATHONOS AVENUE 95 PIKERMI ATTIKIS 19009
English: Miacalcic Nasal 100 100 IU
Icelandic: Miacalcic Nasal 100 100 a.e.
English: PHARMANEL LTD MARATHONOS 106 GERAKAS ATTIKIS
Icelandic: PHARMANEL LTD MARATHONOS 106
English: VOCATE
Icelandic: VOTANIA SA
English: 400 IU
Icelandic: 400 a.e.
English: 2200 i.e./ml
Icelandic: 200 a.e./skammt, 2000 a.e./ML
English: MARATHONOS AVENUE
Icelandic: KM ATHENS-LAVRION AVENUE
English: 50 IU
Icelandic: 50 a.e.
English: The Netherlands
Icelandic: Holland
English: Osseocalcina 200
Icelandic: TONOCALTIN 200
English: ATHENS 17671
Icelandic: ACHARNES 13671
English: NYLEX 100 UI/dose
Icelandic: NYLEX 100 UI/dose 1100 a.e./ml
English: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura
Icelandic: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
English: Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK
Icelandic: Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13453
Icelandic: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13453
English: 100 IU
Icelandic: 100 a.e.
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13452
Icelandic: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13452
English: Calcitonin 'Novartis' 50 I.E./ml - Lösung zur Injektion und Infusion solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Icelandic: Calcitonin 'Novartis' 50 I.E./ml - Lösung zur Injektion und Infusion
English: BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS 30TH KM ATHENSLAVRION AVENUE MARKOPOULO 19003
Icelandic: BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS 30TH
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13451
Icelandic: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13451
English: Via Enrico Fermi 1, Alanno 65020
Icelandic: Alfa Wassermann S.p.A. Via Enrico Fermi 1, Alanno 65020
English: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Icelandic: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie
English: 200 IU
Icelandic: 200 a.e.
English: Sanofi - Produtos Farmacêuticos, Lda.
Icelandic: Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park,
English: PHARMACEUTICAL INDUSTRY
Icelandic: Laboratoire Pharmy
English: Calcitonin-CT 100 I.E./0,1ml Nasenspray 100 IU / dose
Icelandic: Calcitonin-CT 100 I.E./0,1ml
English: Pharma, Gemini, Budova B
Icelandic: Pharma, Gemini, Budova B Na Pankráci 1724/129 Praha 4
English: Pharmaceuticals UK Ltd, Frimley, Camberley, Surrey GU16 7SR, UK
Icelandic: Novartis Pharmaceuticals UK Ltd, Frimley, Camberley, Surrey GU16 7SR, UK
English: Miacalcic Nasal 200 200 IU
Icelandic: Miacalcic Nasal 200 200 a.e.
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
Icelandic: Laboratório NormalProdutos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
English: REMEDINA ABEE GOUNARI 25 & AREOS KAMATERO ATTIKIS
Icelandic: ABEE GOUNARI 25 & AREOS KAMATERO ATTIKIS 13451
English: Karil 200 I.E. Nasenspray
Icelandic: Karil Nasenspray 200 a.e./1 skammt
English: Calcitonin 'Novartis' 100 I.E./ml - Lösung zur Injektion und Infusion solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Icelandic: Calcitonin 'Novartis' 100 I.E./mlLösung zur Injektion und Infusion
English: TONOCALCIN 200 IU nosová aerodisperzia 200 IU/0,1 ml
Icelandic: TONOCALCIN 200 IU nosová aerodisperzia
English: PHARMACEUTICALS LTD PENTELIS AVENUE 34
Icelandic: PENTELIS AVENUE 34-36
English: Via Enrico Fermi, 1 65020 - Alanno (Pescara)
Icelandic: Alfa Wassermann S.p.A. Via Enrico Fermi, 1 65020 - Alanno (Pescara) Italy
English: Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Icelandic: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
English: Pomezia - Roma
Icelandic: - Roma
English: G. LYRA 25, KIFISSIA
Icelandic: Grikkland BIOMEDICA-CHEMICA S.A G. LYRA 25, KIFISSIA
English: Calcitonin-ratiopharm 50 I.E. Ampullen solution for injection intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitoninratiopharm 50 I.E. Ampullen til notkunar í bláæð, til notkunar í vöðva, til notkunar undir húð
English: Novartis Pharma GmbH, Roonstrasse 25, Nurnberg 90429, Germany
Icelandic: GmbH, Roonstrasse 25, Nurnberg 90429, Germany
English: MENANDROU 54 ATHENS 10432
Icelandic: ATHENS 10432
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Icelandic: 5 D-27472 Cuxhaven Germany
English: ETHNIKIS ANTISTASEOS AND TRIFYLLIAS ACHARNES 13671
Icelandic: ETHNIKIS ANTISTASEOS AND TRIFYLLIAS
English: TONOCALCIN 100 IU nosová aerodisperzia 100 IU/0,1 ml
Icelandic: TONOCALCIN 100 IU nosová aerodisperzia
English: S.J.A.
Icelandic: I.E.
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, Torre Fernão de Magalhães10 Esqº
Icelandic: Av. D. João II, Torre Fernão de Magalhães - 10 Esqº 1998-025 Lisboa
English: Rua João de Deus, 19Venda Nova 2700-487 Amadora Portugal
Icelandic: 2700-487 Amadora Portugal
English: Calcitonin-CT 50 I.E./ml Ampullen solution for injection intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitonin-CT 50 I.E./ml Ampullen 50 a.e./1 ml til notkunar í bláæð, til notkunar í vöðva, til notkunar undir húð
English: Empreendimento Lagoas Park,
Icelandic: Zona Industrial do Lagedo
English: OSPOR 200 UI solución para pulverización nasal 200 IU
Icelandic: OSPOR 200 UI solución para pulverización nasal
English: Novartis Pharma B.V. Raapopseweg 1
Icelandic: Novartis Pharma B.V.
English: MEDA PHARMA S.A.U Avda.
Icelandic: MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin.
English: Laboratório NormalProdutos Farmacêuticos, S.A.
Icelandic: ToLife - Produtos Farmacêuticos, S.A.
English: Calcitonin-CT 100 I.E./ml Ampullen solution for injection intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitonin-CT 100 I.E./ml Ampullen 100 a.e./1 ml til notkunar í bláæð, til notkunar í vöðva, til notkunar undir húð
English: Calcitonin 50 I.E.Rotexmedica solution for injection intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitonin 50 I.E.Rotexmedica til notkunar í bláæð, til notkunar í vöðva, til notkunar undir húð
English: 30TH KM ATHENSLAVRION AVENUE MARKOPOULO 19003
Icelandic: MARKOPOULO 19003
English: Pharmaceuticals UK Ltd. Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
Icelandic: Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
English: de Castilla, 2.
Icelandic: Rua da Tapada Grande, 2, Abrunheira
English: Novartis
Icelandic: Novartis Finland
English: Calcitonin 100 I.E.Rotexmedica solution for injection intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitonin 100 I.E.Rotexmedica til notkunar í bláæð, til notkunar í vöðva, til notkunar undir húð
English: MIACALCIC NASAL 200 200 IU/dose
Icelandic: Miacalcic Nasal 200 200 a.e./skammt
English: Calcitonin 100 Jelfa
Icelandic: Calcitonin Stada 100 I.E.
English: 25, ROONSTRASSE D 90429 NUERNBERG
Icelandic: GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany
English: PHARMACEUTICALS LTD, DERVENAKION 38
Icelandic: PHARMACEUTICALS LTD
English: Edif.
Icelandic: ABEE
English: AURORA
Icelandic: Rúmenía
English: Luxembourg
Icelandic: Lisboa
English: CALCO 50 NE/ml injekció solution for injection subcutaneous use, intramuscular use, intravenous use
Icelandic: CALCO 50 NE/ml injekció til notkunar undir húð, til notkunar í vöðva, til notkunar í bláæð
English: NOVARTIS PHARMA GMBH
Icelandic: Novartis Pharma
English: pre-filled syringe subcutaneous use, intramuscular use, intravenous use
Icelandic: Stungulyf/innrennslislyf, lausn til notkunar undir húð, til notkunar í vöðva
English: Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal
Icelandic: Santiago de Besteiros Portugal
English: 200 IU / metered dose
Icelandic: 200 a.e./mældan skammt
English: solution for injection/infusion intravenous use, intramuscular use, subcutaneous use
Icelandic: Stungulyf/innrennslislyf, lausn til notkunar undir húð
English: CALCO 100 NE/ml injekció solution for injection subcutaneous use, intramuscular use, intravenous use
Icelandic: CALCO 100 NE/ml injekció til notkunar undir húð, til notkunar í vöðva, til notkunar í bláæð
English: CALCITONINA SANDOZ 50 UI/ml solution for injection and infusion intravenous use, intramuscular use, subcutaneous use
Icelandic: Calcitonine Sandoz 50 a.e./ml til notkunar í vöðva, til notkunar í bláæð, til notkunar undir húð
English: BIOMEDICA-CHEMICA S.A
Icelandic: Arrowblue Produtos Farmacêuticos S.A.
English: Miacalcic Solution for Injection 100IU/ml solution for injection subcutaneous, intramuscular and intravenous use
Icelandic: Miacalcic Solution for Injection 100IU/ml til notkunar undir húð, til notkunar í vöðva og til notkunar í bláæð
English: ELPEN SA
Icelandic: ELPEN SA PHARMACEUTICAL INDUSTRY
English: blister (alu/alu)
Icelandic: Til inntöku þynna (ál/ál)
English: Pack size bottle (HDPE)
Icelandic: Til inntöku glas (HDPE)
English: Strength Pharmaceutical Form
Icelandic: ESB markaðsleyfisnúmer
English: EU Number
Icelandic: Styrkleiki
English: Strength Pharmaceutical form
Icelandic: Lyfjaform Íkomuleið
English: Immediate packaging
Icelandic: Pakkningastærð
English: Pack size
Icelandic: Styrkleiki
English: MA (EU) Number
Icelandic: ESB markaðsleyfisnúmer
English: Contact our press officer Monika Benstetter
Icelandic: Hafðu samband við fjölmiðlafulltrúa okkar Monika Benstetter
English: 12 December 2016 EMA/868987/2016
Icelandic: 12. desember 2016 EMA/868987/2016
English: More about the medicine
Icelandic: Meira um lyfið
English: References
Icelandic: Heimildir
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Icelandic: Sími +44 (0)20 3660 8427 Netfang: press@ema.europa.eu
English: Information for healthcare professionals
Icelandic: Upplýsingar fyrir heilbrigðisstarfsmenn
English: Information for patients
Icelandic: Upplýsingar fyrir sjúklinga
English: GFR should be assessed before initiation of treatment and at least annually thereafter.
Icelandic: Leggja ætti mat á GFR fyrir upphaf meðferðar og síðan að lágmarki árlega.
English: In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
Icelandic: Í slíkum tilvikum skaltu hætta töku á metformíni í stutta stund og fá frekari leiðbeiningar frá lækninum þínum.
English: • If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
Icelandic: Ef þú hefur spurningar eða áhyggjur af sykursýkismeðferð þinni eða nýrnastarfsemi skaltu ræða við lækni, hjúkrunarfræðing eða lyfjafræðing.
English: The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Icelandic: Endurskoðunin á metformínlyfjum hófst 28. janúar 2016 að beiðni Hollands samkvæmt 31. gr. tilskipunar 2001/83/EB.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Icelandic: Endurskoðunin var framkvæmd af nefnd um lyf, sem ætluð eru mönnum (CHMP), en hún ber ábyrgð á spurningum um lyf sem ætluð eru mönnum en hún samþykkti álit stofnunarinnar.
English: In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Icelandic: Auk þess hefur lyfjablandan glibendclamíð/metformín (Glucovance) verið leyft á landsvísu.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Icelandic: Álit CHMP var áframsent til framkvæmdastjórnar Evrópusambandsins sem gaf út bindandi lokaákvörðun sem gildir í öllum aðildarríkjum Evrópusambandsins frá og með 12/12/2016.
English: The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Icelandic: Núverandi lyfjaupplýsingar eru einnig mismunandi á milli landa og lyfja í ESB og eru ekki lengur í samræmi við klínískar leiðbeiningar.
English: For further information about the centrally authorised medicines, see here.
Icelandic: Frekari upplýsingar um lyf, sem eru háð miðlægri leyfisveitingu, má finna hér.
English: The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Icelandic: Eftirfarandi lyf, sem innihalda blöndu af metformíni og öðrum sykursýkislyfjum í sömu töflu hafa hlotið leyfi með miðlægum hætti í gegnum EMA: pioglitazón/metformín (Competact, Glubrava), dapagliflozín/metformín (Ebymect, Xigduo), sitagliptín/metformín (Efficib, Janumet, Ristfor, Velmetia), linagliptín/metformín (Jentadueto), saxagliptín/metformín (Komboglyze), alogliptín/metformín (Vipdomet), canagliflozín/metformín (Vokanamet), vildagliptín/metformín (Eucreas, Icandra, Zomarist) og empagliflozín/metformín (Synjardy).
English: More about the procedure
Icelandic: Meira um verklagið