FrancophonIA/ELRC3.0 huggingface dataset:
English: < Lansoprazol-ratiopharm and associated names (see Annex I) 30 mg magensaftresistente Hartkapseln > Lansoprazol
Danish: < Lansoprazol-ratiopharm og tilknyttede navne (se Bilag I) 30 mg gastro-resistente hårde kapsler > Lansoprazol
English: < Lansoprazol-ratiopharm and associated names (see Annex I) 15 mg magensaftresistente Hartkapseln > Lansoprazol
Danish: < Lansoprazol-ratiopharm og tilknyttede navne (se Bilag I) 15 mg gastro-resistente hårde kapsler > Lansoprazol
English: ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Germany
Danish: ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm Tyskland
English: NAME OF THE MEDICINAL PRODUCT < Lansoprazol-ratiopharm and associated names (see Annex I) 15 mg magensaftresistente Hartkapseln > lansoprazole
Danish: LÆGEMIDLETS NAVN < Lansoprazol-ratiopharm og tilknyttede navne (se Bilag I) 15 mg gastro-resistent hård kapsel > lansoprazol
English: NAME OF THE MEDICINAL PRODUCT < Lansoprazol-ratiopharm and associated names (see Annex I) 30 mg magensaftresistente Hartkapseln > lansoprazole
Danish: LÆGEMIDLETS NAVN < Lansoprazol-ratiopharm og tilknyttede navne (se Bilag I) 30 mg gastro-resistent hård kapsel > lansoprazol
English: Luxembourg ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danish: Luxembourg ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Tyskland
English: Sweden ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danish: Sverige ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Tyskland
English: HOW TO TAKE Lansoprazol-ratiopharm
Danish: Lansoprazol-ratiopharm
English: Italy ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danish: Italien ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Tyskland
English: Denmark ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danish: Danmark ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Tyskland
English: It is available in all European Member States.
Danish: Det fås i alle EU's medlemsstater.
English: Zometa has been authorised since March 2001.
Danish: Zometa har været godkendt siden marts 2001.
English: The study included 1,803 women previously treated with surgery who received Zometa every six months for three years, and were followed up for five years.
Danish: Undersøgelsen omfattede 1 803 kvinder, som tidligere var blevet kirurgisk behandlet, og som fik Zometa hver sjette måned i tre år og blev fulgt i fem år.
English: The full European Public Assessment Report for Zometa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Zometa findes på EMA's websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The Committee also had concerns regarding the reliability of the data collected during the study.
Danish: Desuden havde udvalget betænkeligheder med hensyn til pålideligheden af de data, der blev indsamlet under undersøgelsen.
English: The study measured ‘disease-free survival' (how long the patients lived without cancer).
Danish: I undersøgelsen målte man den "sygdomsfrie overlevelse" (hvor længe patienterne levede uden kræft).
English: The study was ‘open label': both the doctor and the patient knew which treatment they were using.
Danish: Undersøgelsen var åben, dvs. at både lægen og patienterne vidste, hvilken behandling de fik.
English: There are no consequences on the use of Zometa in its authorised indications.
Danish: Der er ingen konsekvenser for brugen af Zometa i de godkendte indikationer.
English: By blocking this enzyme, it was expected to prevent the growth of cancer cells and cause their death.
Danish: Ved at blokere dette enzym forventedes det at forhindre kræftcellernes vækst og at slå kræftcellerne ihjel.
English: The Committee noted that the treatments used in the control groups to which Zometa was compared were not all representative of the standards of care in Europe.
Danish: Udvalget bemærkede, at de behandlinger, der blev anvendt i de kontrolgrupper, som Zometa blev sammenlignet med, ikke alle var repræsentative for behandlingsstandarderne i Europa.
English: It is approved for use as a drip into a vein every three to four weeks to prevent bone complications such as fractures in adults with advanced cancer that is affecting the bone.
Danish: Det er godkendt til anvendelse som drop i en vene hver tredje til fjerde uge for at forebygge knoglekomplikationer såsom knoglebrud hos voksne med fremskreden kræft, der påvirker knoglerne.
English: The study compared anastrozole and tamoxifen (medicines used in hormone-receptor positive breast cancer) with or without Zometa.
Danish: I undersøgelsen sammenlignede man anastrozol og tamoxifen (lægemidler, der anvendes ved hormonreceptorpositiv brystkræft) med eller uden Zometa.
English: Early breast cancer is breast cancer that has not spread and has been treated by surgery.
Danish: Tidlige stadier af brystkræft er brystkræft, som ikke har bredt sig og er blevet behandlet kirurgisk.
English: What is happening with Zometa for the prevention of bone events in cancer patients?
Danish: Hvad sker der med Zometa til forebyggelse af knoglekomplikationer hos kræftpatienter?
English: Zometa is a medicine that contains the active substance zoledronic acid.
Danish: Zometa er et lægemiddel, der indeholder det aktive stof zoledronsyre.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Danish: På tilbagetrækningstidspunktet var CHMP således af den opfattelse, at lægemidlet ikke kunne have været godkendt på baggrund af de data, som virksomheden havde fremlagt.
English: The company informed the CHMP that this withdrawal does not an impact on ongoing clinical trials with Zometa.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for igangværende kliniske undersøgelser med Zometa.
English: On 14 December 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the treatment of early breast cancer in premenopausal women.
Danish: Den 14. december 2010 meddelte Novartis Europharm Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om en ny indikation for Zometa til behandling af tidlige stadier af brystkræft hos præmenopausale kvinder.
English: The company provided data from one main study to support the use of Zometa in early breast cancer.
Danish: Virksomheden fremlagde data fra en hovedundersøgelse for at underbygge brugen af Zometa ved tidlige stadier af brystkræft.
English: Zometa can also be used to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Danish: Zometa kan også anvendes til behandling af hypercalcæmi (højt calciumniveau i blodet), der skyldes tumorer.
English: Zometa was only to be used if the breast cancer was ‘hormone receptor positive' (the cancer is likely to respond to hormonal treatment), and in combination with hormonal treatment.
Danish: Zometa skulle kun anvendes, hvis brystkræften var hormonreceptorpositiv (dvs. at kræften sandsynligvis vil respondere på hormonbehandling), og i kombination med hormonbehandling.
English: All women also received goserelin, a medicine that suppresses the activity of the ovaries.
Danish: Alle kvinder fik også goserelin, som er et lægemiddel, der hæmmer æggestokkenes aktivitet.
English: It also had concerns regarding the way the study in early breast cancer had been carried out.
Danish: Udvalget havde ligeledes betænkeligheder med hensyn til den måde, som undersøgelsen af tidlige stadier af brystkræft var blevet gennemført på.
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zometa could not have been approved for the adjuvant treatment of early breast cancer.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Zometa ikke kunne have været godkendt til tillægsbehandling af tidlige stadier af brystkræft.
English: Zoledronic acid, the active substance in Zometa, blocks an enzyme called ‘farnesyl pyrophosphate synthase'.
Danish: Zoledronsyre, det aktive stof i Zometa, blokerer et enzym, der kaldes farnesylpyrofosfatsyntase.
English: Zometa was expected to be used as an adjuvant (add-on) in the treatment of early breast cancer in women who have not been through the menopause.
Danish: Zometa forventedes anvendt som adjuvans (tillægsbehandling) til behandling af tidlige stadier af brystkræft hos kvinder, som ikke har været igennem menopausen.
English: The Committee had concerns that the anti-tumour activity of Zometa when used as add-on had not been sufficiently supported by the data from the study.
Danish: Udvalget havde betænkeligheder med hensyn til, at Zometas kræfthindrende aktivitet, når det anvendes som tillægsbehandling, ikke var blevet tilstrækkeligt underbygget af data fra undersøgelsen.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zometa eller i programmer for anvendelse af Zometa med særlig udleveringstilladelse?
English: The way Zometa is expected to works in early breast cancer is not fully elucidated.
Danish: Det er endnu ikke fuldstændigt klart, hvordan Zometa forventes at virke ved tidlige stadier af brystkræft.
English: Studies and Reviews
Danish: Undersøgelser og gennemgange
English: Particular attention should be given to indication, dosage and duration of treatment.
Danish: Der skal udvises særlig opmærksomhed over for indikation, dosering og behandlingsvarighed.
English: Hepatic reactions should be given cumulatively and for the period covered by the PSUR.
Danish: Leverreaktionerne skal vises kumulativt og for den periode, PSUR omfatter.
English: Further updates of the Risk Management Plan should be submitted for assessment at national level.
Danish: Der skal fremlægges yderligere opdateringer af risikostyringsplanen med henblik på vurdering på nationalt plan.
English: The communication shall include comprehensive information on the safety risks associated with the use of nimesulide.
Danish: Denne meddelelse skal indeholde fyldestgørende oplysninger om sikkerhedsrisici forbundet med anvendelse af nimesulid.
English: This retrospective study should lead to a follow-up prospective study in transplant centres.
Danish: Denne retrospektive undersøgelse skal føre til en opfølgende prospektiv undersøgelse i transplantationscentre.
English: A report should be provided to the National Competent authorities for assessment every 6 months as part of the PSUR (starting within one semester after adoption of the Commission Decision).
Danish: Der skal forelægges en rapport for de nationale kompetente myndigheder med henblik på vurdering hver 6. måned som led i PSUR (begyndende inden for et semester efter vedtagelsen af Kommissionens afgørelse).
English: The following conditions in relation to post-marketing surveillance, studies and review and communication shall be fulfilled by the Marketing Authorisation Holders of nimesulide containing medicinal products (systemic formulation).
Danish: Følgende betingelser i relation til overvågning efter markedsføring, undersøgelser og gennemgang samt kommunikation skal opfyldes af indehaverne af markedsføringstilladelsen for lægemidler indeholdende nimesulid (systemisk formulering).
English: This study should address the relative risk of nimesulide in respect to other NSAIDs to cause severe hepatic reactions leading to transplants.
Danish: I denne undersøgelse skal der ses nærmere på den relative risiko ved nimesulid i forhold til andre NSAID med hensyn til at forårsage svære leverreaktioner, der fører til transplantationer.
English: The draft DHPC should be submitted to the CHMP within one month after adoption of the Commission Decision.
Danish: Udkastet til DHPC skal forelægges CHMP senest en måned efter vedtagelsen af Kommissionens afgørelse.
English: Conditions of the Marketing Authorisations
Danish: Betingelser for markedsføringstilladelserne
English: The final study reports of the above studies should be submitted to the National Competent Authorities for assessment.
Danish: Den endelige undersøgelsesrapport om ovennævnte undersøgelser skal forelægges de nationale kompetente myndigheder til vurdering.
English: The protocol should be submitted to the CHMP by 3 months after the completion of the final study report of the retrospective study for review and agreement.
Danish: Protokollen skal forelægges CHMP med henblik på gennemgang og godkendelse senest tre måneder efter færdiggørelsen af den endelige undersøgelsesrapport om den retrospektive undersøgelse.
English: • The MAHs should perform a survey to clarify the modes of use of nimesulide in selected EU Member States to identify potential misuse.
Danish: • Indehaverne af markedsføringstilladelsen skal gennemføre en undersøgelse for at klarlægge, på hvilke måder nimesulid anvendes i udvalgte EU-medlemsstater med henblik på at identificere potentielt misbrug.
English: These PSURs should be submitted to the National Competent Authorities for assessment.
Danish: Disse PSUR skal forelægges de nationale kompetente myndigheder til vurdering.
English: • The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) to be agreed with the CHMP.
Danish: • Indehaverne af markedsføringstilladelsen skal underrette fagfolk inden for sundhedssektoren om resultaterne af denne gennemgang af nimesulid via et “Direct Healthcare Professional Communication” (DHPC) efter aftale med CHMP.
English: These PSURs should include a specific overview of the hepatic reactions.
Danish: Disse PSUR skal omfatte en særlig oversigt over leverreaktioner.
English: • The MAHs should conduct a pre-clinical study on identification of reactive metabolites and protein adduct information.
Danish: • Indehaverne af markedsføringstilladelsen skal gennemføre en præklinisk undersøgelse med sigte på identificering af oplysninger om reaktive metabolitter og proteinaddukter.
English: Post-marketing surveillance
Danish: Lægemiddelovervågning efter markedsføring
English: Competent authorities for assessment within one year after adoption of the Commission Decision.
Danish: Der skal forelægges de nationale kompetente myndigheder en rapport med sigte på vurdering inden for et år efter vedtagelsen af Kommissionens afgørelse.
English: • The MAHs should conduct a retrospective cohort study in transplant centres.
Danish: • Indehaverne af markedsføringstilladelsen skal gennemføre en retrospektiv kohorteundersøgelse i transplantationscentre.
English: The MAHs should strengthen the medical review, refine the monitoring of reporting rates, and improve the quality of Individual Case Safety Reports of nimesulide.
Danish: Indehaverne af markedsføringstilladelsen skal stramme op på den medicinske gennemgang, styrke overvågningen af indberetningsfrekvensen og forbedre kvaliteten af individuelle sikkerhedsrapporter om nimesulid.
English: • The MAHs should perform a monitoring activity to evaluate the effectiveness of risk communication on nimesulide.
Danish: • Indehaverne af markedsføringstilladelsen skal gennemføre overvågningsaktiviteter for at vurdere effektiviteten af risikokommunikationen med hensyn til nimesulid.
English: The MAHs should expedite and submit all safety reports and case series in PSURs for nimesulide, with a six monthly periodicity.
Danish: Indehaverne af markedsføringstilladelsen skal fremskynde og fremlægge alle sikkerhedsrapporter og beskrive serier af tilfælde i PSUR vedrørende nimesulid hvert halve år.
English: • The MAHs should submit a revised Risk Management Plan for nimesulide, considering the comments raised during this procedure, to the CHMP.
Danish: • Indehaverne af markedsføringstilladelsen skal forelægge CHMP en revideret risikostyringsplan for nimesulid under hensyntagen til de bemærkninger, der er fremsat under proceduren.
English: • The MAHs should conduct a review of epidemiological data to review the risk of hepatic damage from nimesulide in comparison with other NSAIDs
Danish: • Indehaverne af markedsføringstilladelsen skal gennemgå de epidemiologiske data for at kortlægge risikoen for leverskade som følge af nimesulid sammenlignet med andre NSAID.
English: 1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
Danish: 1 fyldt pen + 2 alkoholservietter
English: Berlifarma - Especialidades Farmaceuticas, Lda.
Danish: Berlifarma - Especialidad Farmaceuticas, Lda.
English: em., H-1036 Budapest Hungary
Danish: H-1036 Budapest Hungary
English: SANOFI AVENTIS FRANCE 1-13 BOULEVARD ROMAIN ROLLAND
Danish: Sanofi Aventis Frankrig 1-13 Boulevard Romain Rolland
English: 28108 Alcobendas (Madrid) Spain
Danish: 28108 Alcobendas Madrid
English: 92931 PARIS LA DEFENSE FRANCE
Danish: 92931 Paris la Defence France
English: MAROUSSI GR-15125 ATHENS
Danish: Athens GR-15125
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Danish: Rua Quinta Pinheiro, 5, Outurela
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Danish: Holland ratiopharm Nederland B Swensweg 5
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Danish: Osa Mayor, 4 28023 Aravaca Madrid
English: Ilford, Essex IG3 8BS
Danish: Essex IG3 8BS
English: Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary
Danish: Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Danish: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Danish: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta 28108 Alcobendas Madrid
English: EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
Danish: EG LABO - LABORATOIR EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 Boulogne Billancourt Cedex France
English: Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
Danish: Medico Uno Worldwide Ltd. 2 Grigori Afxentiou Stre Larnaca 6023
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Danish: Storbritannien Fannin (UK) Limited 42-46 Booth Drive
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Danish: Viale Certosa, 130 20156 Milano (MI) Italy
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Danish: Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Danish: 25 rue des Peupliers 92000 Nanterre France
English: Comprimidos
Danish: Tablet
English: CYPROTERONE/ETHIN YLESTRADIOL BAYER 35 µg
Danish: CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg
English: Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria
Danish: Bayer Østrig GmbH Herbststrasse 6-10 1160 Wien Austria
English: 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium
Danish: Diestersteenweg 349 3510 Hasselt Belgium
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Danish: Storbritannien Strandhaven Limited 600 High Road
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Danish: Storbritannien Teva UK Limited Brampton Road
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Danish: 92593 Levallois Perret Cedex
English: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
Danish: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Danish: Storbritannien Stragen UK Limited Castle Court 41
English: SANDOZ FARMACEUTICA, S.A.
Danish: Sandoz Farmaceutica, S.A. Avda.
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Danish: Strawberry Hill Newbury, Berkshire RG14 1JA,
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Danish: Farmalider S.A. Calle Aragoneses, 15 28108 Alcobendas Madrid
English: Pelpharma Handels GmbH Stammhausstraße 31 1140 Wien
Danish: Stammhausstraße 31 1140 Wien
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Danish: Storbritannien Chatfield Pharmaceuticals Limited
English: Marszałka J.Piłsudskiego 5 95-200 Pabianice Poland
Danish: 95-200 Pabianice Poland
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Danish: Generis Farmaceutica, S.A. Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: Chloe 35 micrograms/2 mg film-coated tablets
Danish: Chloe 35 micrograms/2 mg filmcoated tablets
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Danish: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Danish: Diane 2000 micrograms/35 micrograms film-coated tablets
English: Reigate, Surrey RH2 9RJ
Danish: Reigate, Surrey RH2 PRJ United Kingdom
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Danish: Rue Saint Georges 5 4000 Liège
English: United Kingdom Sandoz Limited, Frimley Business Park, Frimley,
Danish: Storbritannien Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Danish: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: South, Wellingborough, Kent NN8 6GT
Danish: Kent NN8 6GT
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Danish: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Danish: ACETATO DE CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance 92100 BOULOGNE FRANCE
Danish: Luxembourg Pierre Fabre Dermatologie 45, place Abel Gance
English: Bellgyn "ratiopharm" 2 mg/ 0,035 mgüberzogene Tabletten
Danish: Bellgyn "ratiopharm" 2 mg/ 0,035 mg - überzogene Tabletten
English: Fannin UK CoCyprindiol 2000/35 Tablets
Danish: Fannin UK Co-Cyprindiol 2000/35 Tablets
English: Almirall Hermal GmbH Scholzstr.
Danish: Taurus Pharma GmbH Benzstr.
English: 21465 Reinbek Germany
Danish: 61352 Bad Homburg Germany
English: BAYER ΕΛΛΑΣ ΑΒΕΕ SOROU 18-20
Danish: Grækenland Bayer Hellas ABEE Sorou 18-20
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Danish: Lajos u. 48-66
English: Patient Health Protection
Danish: Indehaver af markedsføringstilladelse
English: Midane - Dragees
Danish: Diane mite - Dragees
English: Cyprus
Danish: Cyprus et
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Danish: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: BN22 9AG
Danish: East Sussex BN22 9AG United Kingdom
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Danish: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: TEVASANTE
Danish: Alcobendas
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Danish: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Camilette CoCyprindiol 2000/35 Tablets
Danish: Camilette Co-Cyprindiol 2000/35 Tablets
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Danish: DK-4230 Skælskør Denmark