FrancophonIA/ELRC3.0 huggingface dataset:
English: London, 4 July 2006 EMEA/169383/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR STAMARIL and associated names (See Annex I) International Non-Proprietary Name (INN): Live attenuated yellow fever virus
Danish: London, den 4. juli 2006 EMEA/169383/2006 UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG I HENHOLD TIL ARTIKEL 30 I RÅDETS DIREKTIV 2001/83/EF OM STAMARIL og tilknyttede navne (se bilag I) Internationalt fællesnavn ( INN): Levende, svækket gul feber-virus
English: On 11 August 2005, Sanofi Pasteur MSD on behalf of all the Marketing Authorisation Holders (see Annex I) presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product STAMARIL and associated names.
Danish: Den 11. august 2005 indbragte Sanofi Pasteur MSD på vegne af alle indehavere af markedsføringstilladelsen (se bilag 1) en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på at harmonisere de nationale produktresuméer for lægemidlet STAMARIL og tilknyttede navne.
English: Ref. EMEA/610140/2008
Danish: EMEA/610140/2008
English: London, 20 November 2008 Doc.
Danish: London, den 20. november 2008 Ref. dok.
English: In both groups, trastuzumab treatment was continued for a year.
Danish: I begge gruppe blev behandlingen med trastuzumab videreført i et år.
English: In both cases, all medicines were to be started at the same time.
Danish: I begge tilfælde blev indgivelsen af lægemidlerne startet samtidig.
English: The main measure of effectiveness was how long the patients survived until their cancer came back.
Danish: Det primære effektmål var den tid, patienterne overlevede, indtil deres kræft vendte tilbage.
English: The evaluation had finished and the CHMP had given a negative opinion.
Danish: Vurderingen var afsluttet, og CHMP havde afgivet en negativ udtalelse.
English: The letters from the company notifying the EMEA of the withdrawal of the application are available here and here.
Danish: Brevene fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her og her.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for yderligere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: The company had initiated an appeal process, but this had not yet finished when the company withdrew.
Danish: Virksomheden havde indledt en appelsag, men denne var endnu ikke afsluttet, da virksomheden trak ansøgningen tilbage.
English: International non-proprietary name (INN): docetaxel
Danish: Internationalt fællesnavn (INN): docetaxel
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Danish: Docetaxel blokerer cellernes evne til at ødelægge det interne "skelet", der gør det muligt for dem at dele og sprede sig.
English: It contains the active substance docetaxel.
Danish: Det indeholder det aktive stof docetaxel.
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Danish: Når skelettet stadig er der, kan cellerne ikke dele sig, og de dør med tiden.
English: What were the main concerns of the CHMP?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder?
English: Docetaxel affects not only cancer cells, but also non-cancer cells such as blood cells, which can cause side effects.
Danish: Docetaxel påvirker ikke blot kræftcellerne, men også celler, der ikke er kræftceller som f.eks. blodceller, hvilket kan medføre bivirkninger.
English: The study compared the effectiveness of the following treatment combinations, which were used in addition to surgery:
Danish: I undersøgelsen blev effektiviteten af følgende behandlingskombinationer, der blev anvendt som supplement til kirurgi, sammenlignet:
English: Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Taxotere/Docetaxel Winthrop
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om ændring af markedsføringstilladelsen for Taxotere/Docetaxel Winthrop
English: There are no consequences on the use of Taxotere/Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser for anvendelsen af Taxotere/Docetaxel Winthrop til de godkendte indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
English: Taxotere/Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be ‘expressing' large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.
Danish: Taxotere/Docetaxel Winthrop forventedes også anvendt til brystkræft, der kan behandles kirurgisk, når kræften har vist sig at "udtrykke" store mængder HER2: Dette er en type kræft, som producerer (udtrykker) et specifikt protein kaldet HER2 i store mængder på overfladen af tumorcellerne.
English: On 14 November 2008, Sanofi-Aventis Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Taxotere/Docetaxel Winthrop, to add the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Danish: Den 14. november 2008 meddelte Sanofi-Aventis Pharma S.A. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om en ny indikation for Taxotere/Docetaxel Winthrop for at tilføje behandling af patienter med operabel brystkræft, hvis tumorer overudtrykker HER2, i kombination med trastuzumab med eller uden carboplatin.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Taxotere/Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Taxotere/Docetaxel Winthrop ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Taxotere/Docetaxel Winthrop has been studied in one main study involving over 3,000 women with HER2-expressing breast cancer that could be treated with surgery.
Danish: Taxotere/Docetaxel Winthrop er blevet undersøgt i en hovedundersøgelse med deltagelse af over 3.000 kvinder med HER2-ekspressiv brystkræft, der kunne behandles kirurgisk.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Taxotere/Docetaxel Winthrop til patienter med operabel brystkræft, hvis tumorer overudtrykker HER2, i kombination med trastuzumab med eller uden carboplatin.
English: The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/Docetaxel Winthrop, carboplatin and trastuzumab.
Danish: CHMP var også betænkelig ved, at virksomheden ikke fremlagde tilstrækkelige kliniske beviser, der kunne retfærdiggøre brugen af kombinationen Taxotere/Docetaxel Winthrop, carboplatin og trastuzumab.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Taxotere/Docetaxel Winthrop?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med Taxotere/Docetaxel Winthrop?
English: Taxotere/Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab;
Danish: Winthrop i 12 uger, enten alene eller i kombination med trastuzumab
English: • together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide;
Danish: • sammen med trastuzumab (et andet lægemiddel mod kræft) efter behandling med doxurubicin og cyclophosphamid
English: In these patients, Taxotere/Docetaxel Winthrop is used in addition to surgery to remove the tumour, together with doxorubicin and cyclophosphamide (other anticancer medicines).
Danish: Hos disse patienter anvendes Taxotere/Docetaxel Winthrop sammen med kirurgi til at fjerne tumoren sammen med doxorubicin og cyclophosphamid (andre lægemidler mod kræft).
English: The active substance in Taxotere/Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the ‘taxanes'.
Danish: Det aktive stof i Taxotere/Docetaxel Winthrop, docetaxel, tilhører gruppen af lægemidler mod kræft kendt som ”taxaner”.
English: • the combination of Taxotere/Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.
Danish: • kombinationen Taxotere/Docetaxel Winthrop, trastuzumab og carboplatin i 18 uger.
English: The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed.
Danish: CHMP fandt grund til betænkelighed ved, at det ikke var muligt at fastslå fordelene ved de behandlingskombinationer, der omfattede Taxotere/Docetaxel Winthrop som supplement til kirurgi, på grund af udformningen af den eneste hovedundersøgelse.
English: Taxotere/Docetaxel Winthrop is an anticancer medicine.
Danish: Taxotere/Docetaxel Winthrop er et lægemiddel mod kræft.
English: What is happening for Taxotere/Docetaxel Winthrop for the treatment of other types of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer?
Danish: Hvad sker der med Taxotere/Docetaxel Winthrop til behandling af andre typer brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk adenocarcinom og kræft i hoved og hals?
English: • together with trastuzumab and carboplatin (another anticancer medicine).
Danish: • sammen med trastuzumab og carboplatin (et andet lægemiddel mod kræft).
English: Taxotere/Docetaxel Winthrop was expected to be used in addition to surgery to remove the tumour in the following treatment combinations:
Danish: Taxotere/Docetaxel Winthrop forventedes anvendt sammen med kirurgi til at fjerne tumoren i følgende behandlingskombinationer:
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/Docetaxel Winthrop.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Taxotere/Docetaxel Winthrop.
English: It is used in breast cancer that is advanced or ‘metastatic' (has spread to other parts of the body), and in breast cancer that can be treated with surgery.
Danish: ”metastatisk” brystkræft (den har bredt sig til andre dele af kroppen) og til operabel brystkræft.
English: Taxotere/Docetaxel Winthrop is a concentrate and solvent, which are made up into a solution for infusion (drip into a vein).
Danish: Taxotere/Docetaxel Winthrop er et koncentrat og en opløsning, der blandes til en infusionsvæske (drop i en vene).
English: What is Taxotere/Docetaxel Winthrop?
Danish: Hvad er Taxotere/Docetaxel Winthrop?
English: • the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by
Danish: • kombinationen af doxorubicin og cyclophosphamid i 12 uger efterfulgt af Taxotere/Docetaxel
English: Taxotere/Docetaxel Winthrop is also used in advanced or metastatic non-small cell lung cancer, in prostate cancer, in metastatic gastric adenocarcinoma (a type of stomach cancer) and in advanced head and neck cancer.
Danish: Taxotere/Docetaxel Winthrop anvendes også til fremskreden eller metastatisk ikke-småcellet lungekræft, prostatakræft, metastatisk gastrisk adenocarcinom (en type mavekræft) og fremskreden kræft i hoved og hals.
English: How is Taxotere/Docetaxel Winthrop expected to work?
Danish: Hvordan forventes Taxotere/Docetaxel Winthrop at virke?
English: What was Taxotere/Docetaxel Winthrop expected to be used for?
Danish: Hvad forventedes Taxotere/Docetal Winthrop anvendt til?
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej samt indehavere af markedsføringstilladelse i medlemsstaterne
English: Slovak Republic ratiopharm International GmbH
Danish: Slovakiet ratiopharm International GmbH
English: ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL del Mare 36 - 00040
Danish: ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL del Mare 36 - 00040 Pomezia - Roma
English: PHARMACEUTICALS 1ST KM PAIANIASMARKOPOULOU AVENUE PAIANIA 19002
Danish: DOCTUM PHARMACEUTICALS 1ST KM PAIANIASMARKOPOULOU AVENUE PAIANIA 19002
English: Germany mibe GmbH Arzneimittel Münchener Str. 15
Danish: Tyskland mibe GmbH Arzneimittel Münchener Str. 15
English: Zambon France 13 rue René Jacques 92138 Issy les Moulineaux CedexFrance
Danish: Zambon France 13 rue René Jacques 92138 Issy les Moulineaux Cedex - France
English: 200IU in 1ml
Danish: 200 IE i 1ml
English: Wincentego st. Pola 21 58-500, Jelenia Góra, Poland
Danish: 58-500, Jelenia Góra, Poland
English: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 OriggioVARESE
Danish: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 Origgio - VARESE
English: ALPHA GENERICS THERAPY AEBEF KORYTSAS 13
Danish: ALPHA GENERICS THERAPY AEBEF
English: VOTANIA SA PEGASSOU 18
Danish: PEGASSOU 18
English: PHARMACEUTICALS SA GOUNARI 150, GLYFADA 16674
Danish: GOUNARI 150, GLYFADA 16674
English: FARMEDIA SA ATHINAS 22 AND APOLLONOS GERAKAS ATTIKIS
Danish: FARMEDIA SA ATHINAS 22 AND APOLLONOS
English: LEOVAN M. LEON AND CO
Danish: LEOVAN M. LEON AND CO MENANDROU 54
English: MEDIMAR SA MEDICINES COSMETICS KIFISSIAS 13
Danish: MEDIMAR SA MEDICINES COSMETICS
English: 18th km Athens-Lamia National Road 146 71 Nea Erythrea Greece
Danish: Vianex SA, Tatoiou street, 18th km Athens-Lamia National Road 146 71 Nea Erythrea Greece
English: Osteodon 200 IU.
Danish: Osteodon 200 I.U.
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Danish: Tyskland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: 635 00 Brno Czech republic
Danish: 635 00 Brno
English: TONOCALCIN 100 IU nosová aerodisperzia 100 IU/0,1 ml
Danish: TONOCALCIN 100 IU nosová aerodisperzia 100 IE/0,1 ml
English: LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA Via Licinio, 11
Danish: LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA
English: ALMIRALL, S.A.Ronda General Mitre, 151
Danish: ALMIRALL, S.A.Ronda General Mitre, 151 08022 Barcelona
English: ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3Edificio Suécia III, Piso 1
Danish: Avenida do Forte, 3 - Edificio Suécia III,
English: 200 IU/dose, 2000 IU/ML
Danish: 200 IE/dosis, 2000 IE/ml
English: FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain
Danish: NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 Barcelona 08013 Spain
English: Gentsesteenweg 615 1080 Brussels Belgium
Danish: Nycomed Belgium sca/cva Gentsesteenweg 615 1080 Brussels Belgium
English: EVAGGELOS KALOFOLIAS IAPHARM MENANDROU 54
Danish: EVAGGELOS KALOFOLIAS IAPHARM
English: Av. José MalhoaEdifício Malhoa Plaza nº piso-escritório 2.2 1070-325 Lisboa Portugal
Danish: Av. José Malhoa - Edifício Malhoa Plaza nº 2, piso-escritório 2.2
English: 41 Chalton street, London, NW1 1JD, United Kingdom
Danish: VERISFIELD (UK) LTD, U.K. 41 Chalton street, London, NW1 1JD, United Kingdom
English: PHARMACEUTICALS SA KIFISSOU AVENUE 122 PERISTERI 1231
Danish: KIFISSOU AVENUE 122 PERISTERI 1231
English: Via Enrico Fermi, 1 65020 - Alanno (Pescara)
Danish: Via Enrico Fermi, 1 65020 - Alanno (Pescara) Italy
English: Novartis FarmaProdutos Farmacêuticos, S.A.
Danish: Novartis Farma - Produtos Farmacêuticos, S.A.
English: SANOFI AVENTIS, S.A.Josep Plá, 2
Danish: SANOFI AVENTIS, S.A.Josep Plá, 2 Barcelona 08019 SPAIN
English: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14 03006 Alicante
Danish: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14
English: VOCATE
Danish: VOTANIA SA
English: Laboratoire Sandoz 49 avenue Georges Pompidou
Danish: Laboratoire Sandoz 49 avenue Georges Pompidou 92300 Levallois-PerretFrance
English: UCB Pharma GmbH Geiselbergstraße 1719/2, 5.Stock 1110 Wien, Austria
Danish: UCB Pharma GmbH Geiselbergstraße 17-19/2, 5.Stock
English: PIKERMI ATTIKIS 19009
Danish: MARATHONOS AVENUE 95 PIKERMI ATTIKIS 19009
English: Miacalcic Nasal 200 Nasal Spray Solution 200IU/dose
Danish: Miacalcic Nasal 200 Nasal Spray Solution 200IE/dosis
English: 200 IU / metered dose
Danish: 200 IE/afmålt dosis
English: PHARMANEL LTD MARATHONOS 106 GERAKAS ATTIKIS
Danish: PHARMANEL LTD MARATHONOS 106
English: Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
Danish: Przedsiębiorstwo Farmaceutyczne Jelfa S.A. Wincentego st. Pola 21
English: 400 IU
Danish: 400 IE
English: 50 IU
Danish: 50 IE
English: 12th Km National Highway
Danish: 12th Km National Highway Metamorfosi Attikis 14452
English: NYLEX 100 UI/dose
Danish: NYLEX 100 UI/dosis 1100 IE/ml
English: Miacalcic Nasal 100 100 IU
Danish: Miacalcic Nasal 100 100 IE
English: Calcitonin-CT 100 I.E./0,1ml Nasenspray 100 IU / dose
Danish: Calcitonin-CT 100 I.E./0,1ml Nasenspray
English: ATHENS 17671
Danish: ACHARNES 13671
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13453
Danish: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13453
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13452
Danish: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13452
English: PHARMACEUTICALS SA EVROU 4 AND MESSINIAS 2
Danish: EVROU 4 AND MESSINIAS 2 GERAKAS 15344
English: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura
Danish: Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
English: Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK
Danish: Novartis Pharmaceuticals Uk Ltd, Frimley Business Park, Frimley, Camberley, Surrey, UK
English: Miacalcic 400 IU /2ml Solution for Injection and infusion
Danish: Miacalcic 400 IE /2ml Injektionsvæske, opløsning and infusion
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13451
Danish: IASIS PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13451
English: Osseocalcina 200
Danish: Osseocalcina 200 200 IE/dosis
English: Calcitonin 'Novartis' 50 I.E./ml - Lösung zur Injektion und Infusion solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Danish: Calcitonin 'Novartis' 50 I.E./ml - Lösung zur Injektion und Infusion
English: 200 IU
Danish: 200 IE
English: Calcitonin 100 Jelfa
Danish: Calcitonin 100 Jelfa 100 IE/ml
English: Miacalcic Nasal 200 200 IU
Danish: Miacalcic Nasal 200 200 IE
English: Miacalcic 200 IU Nasal Spray
Danish: Miacalcic 200 IE Nasal Spray
English: G. LYRA 25, KIFISSIA
Danish: BIOMEDICA-CHEMICA S.A G. LYRA 25, KIFISSIA
English: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Danish: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie
English: United Kingdom
Danish: England
English: Pharma, Gemini, Budova B
Danish: Pharma, Gemini, Budova B Na Pankráci 1724/129 Praha 4
English: Pharmaceuticals UK Ltd, Frimley, Camberley, Surrey GU16 7SR, UK
Danish: Novartis Pharmaceuticals UK Ltd, Frimley, Camberley, Surrey GU16 7SR, UK
English: 2200 i.e./ml
Danish: Osteos 50 I.E./ml
English: 30TH KM ATHENSLAVRION AVENUE MARKOPOULO 19003
Danish: 30TH KM ATHENS-LAVRION AVENUE
English: Calcitonin 'Novartis' 100 I.E./ml - Lösung zur Injektion und Infusion solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Danish: Calcitonin 'Novartis' 100 I.E./ml - Lösung zur Injektion und Infusion
English: 100 IU
Danish: 100 IE
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
Danish: Laboratório NormalProdutos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal
English: Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Danish: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
English: Injection subcutaneous use
Danish: Intramuskulær anvendelse
English: PHARMACEUTICALS LTD PENTELIS AVENUE 34
Danish: PENTELIS AVENUE 34-36
English: MENANDROU 54 ATHENS 10432
Danish: ATHENS 10432
English: ETHNIKIS ANTISTASEOS AND TRIFYLLIAS ACHARNES 13671
Danish: ETHNIKIS ANTISTASEOS AND TRIFYLLIAS
English: MIACALCIC NASAL 200 200 IU/dose
Danish: Miacalcic Nasal 200 200 IE/dosis
English: powder and solvent for solution for injection intramuscular use, subcutaneous use
Danish: Pulver og solvens til injektionsvæske, opløsning
English: PHARMACEUTICAL INDUSTRY
Danish: ELPEN SA PHARMACEUTICAL INDUSTRY
English: MIACALCIC 50 NE/ml oldatos injekció és infúzió solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Danish: MIACALCIC 50 NE/ml oldatos injekció és infúzió
English: OSPOR 200 UI solución para pulverización nasal 200 IU
Danish: OSPOR 200 UI solución para pulverización nasal
English: solution for injection subcutaneous use, intramuscular use, intravenous use
Danish: Subkutan anvendelse, Intramuskulær anvendelse, Intravenøs anvendelse
English: Novartis Pharma B.V. Raapopseweg 1
Danish: Novartis Pharma B.V.
English: TONOCALCIN 200 IU nosová aerodisperzia 200 IU/0,1 ml
Danish: TONOCALCIN 200 IU nosová aerodisperzia
English: Rua João de Deus, 19Venda Nova 2700-487 Amadora Portugal
Danish: 2700-487 Amadora Portugal
English: Laboratório NormalProdutos Farmacêuticos, S.A.
Danish: ToLife - Produtos Farmacêuticos, S.A.
English: 200 IU/dose nasal spray, liquid nasal use
Danish: 200 IE/1 dosis Næsespray, opløsning
English: solution for injection intramuscular use, intravenous use, subcutaneous use
Danish: Intramuskulær anvendelse, Intravenøs anvendelse, Subkutan anvendelse
English: BALU COMMERCE OF PARAPHARMACEUTICALS AND COSMETICS 30TH KM ATHENSLAVRION AVENUE MARKOPOULO 19003
Danish: MEDHEL HELLAS PHARMACEUTICAL INDUSTRY 30TH KM ATHENS-LAVRION AVENUE
English: Pharmaceuticals UK Ltd. Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
Danish: Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
English: solution for injection intravenous use, intramuscular use, subcutaneous use
Danish: Intravenøs anvendelse, Intramuskulær anvendelse, Subkutan anvendelse
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, Torre Fernão de Magalhães10 Esqº
Danish: Av. D. João II, Torre Fernão de Magalhães - 10 Esqº 1998-025 Lisboa Portugal
English: MARATHONOS AVENUE
Danish: PARADEISOS MAROUSSIOU
English: Calcitonin Stada 50 I.E. Injektionslösung solution for injection intravenous use, intramuscular use, subcutaneous use
Danish: Calcitonin Stada 50 I.E. Injektionslösung 50 IE/1 ml
English: solution for injection intramuscular use, subcutaneous use
Danish: Intramuskulær anvendelse, Subkutan anvendelse
English: Annex I
Danish: ALAPIS ABEE
English: Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal
Danish: Santiago de Besteiros Portugal
English: Calcitonin-ratiopharm 50 I.E. Ampullen solution for injection intravenous use, intramuscular use, subcutaneous use
Danish: Calcitonin-ratiopharm 50 I.E. Ampullen