FrancophonIA/ELRC3.0 huggingface dataset:
English: Thanks to the new legislation, the Agency was able to introduce a number of procedures which provide faster availability of most-needed medicines and assure high quality of the results of the work performed.
Danish: hurtigere adgang til de mest nødvendige lægemidler og sikrer en høj kvalitet i resultaterne af det udførte arbejde.
English: Variation and extension applications (Veterinary medicines)
Danish: Ansøgninger om ændringer og forlængelser (veterinærlægemidler)
English: New medicinal products (non-orphan)
Danish: Nye lægemidler (ikke til sjældne sygdomme)
English: The Agency will publish Q&A documents at the time of adoption of the CHMP opinion, thus ensuring transparency on arbitration and referral procedures.
Danish: Agenturet vil i forbindelse med vedtagelse af CHMP's udtalelser offentliggøre dokumenter med spørgsmål og svar for derigennem at sikre gennemsigtighed i voldgifts- og henvisningsprocedurerne.
English: 2 Committee for Medicinal Products for Human Use (CHMP).
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP).
English: Variation and extension applications (Human medicines)
Danish: Ansøgninger om ændringer og forlængelser (humanmedicinske lægemidler)
English: Expertise needed in the working parties will be addressed together with the Heads of Medicines Agencies.
Danish: Agenturet vil i samråd med lægemiddelagenturernes styrelseschefer gennemgå arbejdsgruppernes behov for ekspertise.
English: EU reports (centrally authorised products) Non-EU reports (centrally authorised products) EU reports (nationally authorised products) Non-EU reports (nationally authorised products)
Danish: Indberetninger fra lande uden for EU (centralt godkendte produkter)
English: Work will continue on strengthening the quality and the regulatory and scientific consistency of CHMP2 opinions and assessment reports in the post authorisation phase, building on improvements introduced in 2006.
Danish: Agenturet vil med afsæt i de forbedringer, der blev gennemført i 2006, fortsat arbejde på at øge kvaliteten og den forskriftsmæssige og videnskabelige konsekvens i udtalelser og evalueringsrapporter fra CHMP2 i fasen efter godkendelsen.
English: Press officer
Danish: Pressesekretær
English: 2.9 Herbal medicinal products
Danish: 2.9 Plantelægemidler
English: Number of reimbursed delegates
Danish: Antal delegerede, der modtager godtgørelse
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Danish: Martin HARVEY ALLCHURCH Tlf. (direkte nr.): (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
English: EudraVigilance (In production)
Danish: EudraVigilance (under udvikling)
English: The Agency will organise training activities on GCP and Quality/GMP and will further develop the cooperation between inspection and assessment functions, particularly through the work of the Process Analytical Technology team and joint sessions with GMP inspectors/Quality assessors and GCP inspectors /Clinical assessors.
Danish: Dette skal navnlig ske via arbejdet i procesanalyseteknologi-gruppen og fælles møder med GMPinspektører/kvalitetsbedømmere og GCP-inspektører/kliniske bedømmere.
English: Scientific opinions for non-EU markets
Danish: Videnskabelige udtalelser til markeder uden for EU Lægemidler med særlige udleveringstilladelse
English: Safety of medicines for human and veterinary use
Danish: Sikkerhed i forbindelse med human- og veterinærmedicinske lægemidler
English: 5 Support activities
Danish: Støtteaktiviteter
English: It will continue to implement the policy on micro, small and medium-sized enterprises (SMEs), which are often innovative companies working in the field of new technologies and emerging therapies; will continue to provide high-quality scientific advice to companies developing medicinal products; will support the development of orphan medicinal products; and will actively participate in the Innovative Medicines Initiative.
Danish: Det vil fortsat tilvejebringe videnskabelig rådgivning af høj kvalitet til virksomheder, som udvikler lægemidler, og støtte udviklingen af lægemidler til sjældne sygdomme samt aktivt deltage i initiativet vedrørende innovative lægemidler.
English: − In light of the increasing tasks at the EU level and the arrival of novel therapies and technologies, work to ensure availability for the network of the highest-quality expertise at EU level for the evaluation of medicines and for monitoring and assessing their safety.
Danish: − Indsats for at sikre adgang via netværket til den højeste sagkundskab på EU-plan i forbindelse med evaluering af lægemidler og overvågning og vurdering af deres sikkerhed, hvilket skal ses i lyset af de voksende arbejdsopgaver på EU-plan og fremkomsten af nye behandlingsformer ogteknologier.
English: Despite initiatives taken by the CVMP1 to facilitate the authorisation of products for minor uses and minor species, the number of associated extensions and modifications has remained stable over the last years - a situation likely to continue in 2007, with 5 applications being predicted.
Danish: arter er antallet af hermed forbundne forlængelser eller ændringer forblevet på samme niveau i de seneste år, hvilket også forventes at blive tilfældet i 2007, hvor man forventer, at der indgives fem ansøgninger.
English: Silvia DOMINGO ROIGÉ Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Danish: Silvia DOMINGO ROIGÉ Tlf. (direkte nr.): (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
English: Direct telephone: (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.europa.eu
Danish: Tlf. (direkte nr.): (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.europa.eu
English: Arbitration and Community referrals (Veterinary medicines)
Danish: Voldgift og henvisning af sager til Fællesskabet (veterinærlægemidler)
English: Direct telephone: (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.europa.eu
Danish: Tlf. (direkte nr.): (44-20) 74 18 85 81 E-mail: fia.westerholm@emea.europa.eu
English: 2.1 Orphan medicinal products for human use
Danish: 2.1 Humanmedicinske lægemidler til sjældne sygdomme
English: This EMEA work programme for 2007 has been shaped by a number of factors in the rapidly developing medicines regulation environment, most notably the entry into force of the legislation on paediatric medicines.
Danish: Lægemiddellovgivningen har udviklet sig med rivende hast, og en lang række faktorer her har været med til at sætte deres fingeraftryk på EMEA's arbejdsprogram for 2007, ikke mindst ikrafttrædelsen af lovgivningen om pædiatriske lægemidler, som er et vigtigt nyt mandat for EMEA, da det tildeler agenturet en væsentlig rolle inden for fremme af adgangen til sikre og effektive lægemidler til børn.
English: For enquiries concerning certificates for centrally
Danish: For forespørgsler vedrørende certifikater for
English: Medicines for human and veterinary use
Danish: Human- og veterinærmedicinske lægemidler
English: Function Group & Grade
Danish: Funktionsgruppe og løntrin
English: Direct telephone: (44-20) 74 18 85 75/86 43 Fax: (44-20) 75 23 70 40
Danish: Tlf. (direkte nr): (44-20) 74 18 85 75/86 43 Fax: (44-20) 75 23 70 40
English: It will work with the Heads of Veterinary Medicines Agencies on availability and will provide support to the European Technology Platform for Global Animal Health,
Danish: Det vil samarbejde med lægemiddelagenturernes styrelseschefer om at sikre adgang til lægemidler samt støtte den europæiske teknologiplatform for dyresundhed globalt set, som har til formål at fremskynde udviklingen af nye produkter i dyresundhedssektoren til både større og mindre markeder.
English: Medicines agencies have traditionally relied on spontaneous reporting of adverse reactions, and the EMEA EudraVigilance database remains a key tool for this.
Danish: Lægemiddelagenturer har traditionelt støttet sig til spontane indberetninger om bivirkninger.
English: EudraCT (In production)
Danish: EudraCT (under udvikling)
English: EudraPharm (In production)
Danish: EudraPharm (under udvikling)
English: Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.europa.eu
Danish: (44-20) 74 18 85 56 E-mail: iqmanagement@emea.europa.eu
English: EudraNet (In production)
Danish: EudraNet (under udvikling)
English: Direct telephone: (44-20) 75 23 71 07 Fax: (44-20) 74 18 85 95
Danish: Tlf. (direkte nr.): (44-20) 75 23 71 07 Fax: (44-20) 74 18 85 95
English: Direct telephone: (44-20) 75 23 7114 Fax: (44-20) 74 18 85 45
Danish: Tlf. (direkte nr.): (44-20) 75 23 7114 Fax: (44-20) 74 18 85 45
English: MRL ext./mod.
Danish: Marijke KORTEWEG Tlf. (direkte nr.):.
English: Similar biological products
Danish: Bioækvivalente lægemidler
English: Eudra Data
Danish: Eudra Data Warehouse (under udvikling)
English: Type-IA variations
Danish: Type-IA-ændringer
English: New applications for veterinary medicines
Danish: Nye ansøgninger om veterinærlægemidler modtaget/forventet
English: For matters relating to pharmacovigilance for
Danish: For spørgsmål vedrørende lægemiddelovervågning af Fia WESTERHOLM veterinærlægemidler
English: General EU contribution EU contribution for SME policy EU contribution for Paediatrics policy n/a 0.00 2,647 1.71
Danish: 0 0,00 Ikke relevant 0,00 2 647 1,71
English: Compassionate-use products
Danish: Produktserieudvidelser
English: New medicinal products (orphan)
Danish: Nye lægemidler (til sjældne sygdomme)
English: SME Office
Danish: SMV-kontor
English: The procedure started on 25 September 2014.
Danish: Proceduren blev indledt den 25. september 2014.
English: These statements were carefully assessed.
Danish: Disse erklæringer er blevet nøje vurderet.
English: Nor does it allow for the findings of a previous inspection to be ignored.
Danish: Ligeledes tillader det ikke at se bort fra resultaterne af en tidligere inspektion.
English: The medicinal products concerned are listed in Annex I.
Danish: De berørte lægemidler er anført i bilag I.
English: Considerations to all products reviewed within the framework of this procedure
Danish: Overvejelser vedrørende alle lægemidler, der er gennemgået inden for rammerne af denne procedure
English: Discussions
Danish: Drøftelse
English: The grounds submitted were taken into consideration and assessed by the CHMP.
Danish: Den forelagte begrundelse blev taget i betragtning og vurderet af CHMP.
English: It is recognised that alendronate occupies an important place in the treatment of post-menopausal osteoporosis.
Danish: Det anerkendes, at alendronat indtager en vigtig plads i behandlingen af postmenopausal osteoporose.
English: The data manipulations took place between at least July 2008 and 2013.
Danish: Datamanipulationerne fandt som minimum sted i perioden juli 2008 til 2013.
English: Annex II Scientific conclusions and grounds for the recommendations for maintenance and suspension of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for anbefalingerne om opretholdelse og suspendering af markedsføringstilladelserne
English: Grounds for CHMP Opinion
Danish: Begrundelse for CHMP's udtalelse
English: Therefore the information submitted at the stage of reexamination was taken into consideration in order to safeguard the right of defence of the company.
Danish: Oplysninger indsendt på tidspunktet for fornyet overvejelse blev derfor taget i betragtning for at varetage virksomhedens ret til forsvar.
English: The CHMP therefore decided to extend the scope of the review by also including studies performed between 2004 and 2008.
Danish: CHMP besluttede derfor at udvide gennemgangen til også at omfatte undersøgelser udført fra 2004 til 2008.
English: Category 2 medicinal products
Danish: Lægemidler i kategori 2
English: • Composition differences - the test product contains critical excipients that may affect the pharmacokinetics profile of the medicinal product (absorption).
Danish: • Forskelle i sammensætning - det testede lægemiddel indeholder kritiske hjælpestoffer, der kan påvirke lægemidlets farmakokinetiske profil (absorption).
English: Only a synopsis of a pilot study has been submitted.
Danish: Der er kun forelagt et resumé af en pilotundersøgelse.
English: Category 1 medicinal products
Danish: Lægemidler i kategori 1
English: In addition, inspections by regulatory authorities follow a sampling process in which specific parts of a particular activity are looked at in detail to establish whether its conduct complied with all relevant guidelines and regulations.
Danish: Desuden benytter tilsynsmyndighederne ved inspektionen en stikprøveprocedure, hvor specifikke dele af en given aktivitet undersøges nøje med henblik på, om den er udført i overensstemmelse med alle relevante retningslinjer og bestemmelser.
English: The full bioanalytical report is missing.
Danish: Der savnes en fuldstændig bioanalytisk rapport.
English: This reference medicinal product has to be authorised in the EU under the EU procedures described in Article 6 and in accordance with the EU requirements defined in Article 8 of the said Directive.
Danish: Referencelægemidlet skal være godkendt i EU i henhold til EU-procedurerne beskrevet i artikel 6 og i overensstemmelse med EUkravene fastlagt i artikel 8 i nævnte direktiv.
English: These data manipulations cast doubts on the authenticity of all other clinical records of these nine clinical trials.
Danish: Datamanipulationerne rejser tvivl om ægtheden af alle andre kliniske journaler vedrørende disse ni kliniske undersøgelser.
English: The reference product is not authorized in the EU.
Danish: Referencelægemidlet er ikke godkendt i EU.
English: As stated in Article 62(1) paragraph 4 of Regulation (EC) No 726/2004 and Article 32(4) paragraph 3 of Directive 2001/83/EC, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.” Therefore these scientific data can not be considered during the re-examination procedure.
Danish: I artikel 62, stk. 1, 4. led, i forordning (EF) nr. 726/2004 og artikel 32, stk. 4, 3. led, i direktiv 2001/83/EF fastslås: "Proceduren vedrørende anmodning om fornyet overvejelse må kun vedrøre punkter i den oprindelige udtalelse, som ansøgeren i forvejen har peget på, og den må kun bero på de videnskabelige data, der forelå, da udvalget vedtog den oprindelige udtalelse."
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products concerned by the GVK Bio procedure;
Danish: • Udvalget fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler omfattet af proceduren vedrørende GVK Bio.
English: • Re-examination request for Nebivolol Genericon Pharma Austria
Danish: • Anmodning om fornyet overvejelse for Nebivolol Genericon Pharma Austria
English: For the above reasons, the lack of proof of bioequivalence can not be substituted by post marketing experience data.
Danish: Af ovennævnte grunde kan den manglende påvisning af bioækvivalens ikke erstattes af data om erfaringer efter markedsføring.
English: That being the case, volunteers would be unnecessarily exposed to a medicinal product without a clear need, which is not acceptable from an ethical point of view.
Danish: Som følge heraf vil forsøgspersoner uden klart behov blive eksponeret for et lægemiddel, hvilket ikke er etisk acceptabelt.
English: This means that a successful outcome in a particular inspection cannot be taken as a guarantee that all processes are properly run and GCP compliant.
Danish: Et vellykket resultat af en bestemt inspektion kan derfor ikke tages som garanti for, at alle processer er korrekt udført i overensstemmelse med GCP.
English: The European Commission initiated a referral under article 31 of Directive 2001/83/EC on 4 August 2014.
Danish: Europa-Kommissionen indledte den 4. august 2014 en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF.
English: The Committee therefore recommends that these marketing authorisations (Annex IB) should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Danish: Udvalget anbefaler derfor, at disse markedsføringstilladelser (bilag IB) suspenderes, medmindre lægemidlet anses for kritisk nødvendigt af de pågældende kompetente nationale myndigheder.
English: For the purpose of this report, GVK Biosciences Private Limited/Clinogent will be hereafter referred to as ‘GVK Bio'.
Danish: I denne rapport benævnes GVK Biosciences Private Limited/Clinogent herefter "GVK Bio".
English: The French Agency on medicinal products (ANSM) conducted an inspection on 19-23 May 2014 (inspection reference GCP-141001-FR) at GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India.
Danish: Den franske lægemiddelstyrelse (ANSM) foretog den 19.-23. maj 2014 en inspektion (med reference GCP-141001-FR) hos GVK Biosciences Private Limited, Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, Indien.
English: The clinical phase was conducted at GVK Bio; the bioanalytical, pharmacokinetic and statistical phases of the study were carried out by another CRO.
Danish: Den kliniske fase blev udført hos GVK Bio, mens den bioanalytiske, farmakokinetiske og statistiske fase af undersøgelsen blev udført af en anden kontraktforskningsorganisation.
English: This period of deferral shall not exceed twenty-four months from the Commission Decision.
Danish: Perioden for udskydelsen kan ikke overstige 24 måneder, regnet fra Kommissionens beslutning.
English: • Re-examination request for Nebivolol Neo-Balkanika:
Danish: • Anmodning om fornyet overvejelse for Nebivolol Neo-Balkanika:
English: The following findings were reported in the French inspection report dated 02 July 2014, to which GVK Bio have responded on 18 July 2014 and in the final inspection report, which was issued on 21 July 2014: data manipulations of electrocardiograms (ECGs) were detected in each and every one of the 9 trials inspected by the ANSM.
Danish: Følgende resultater fremgik af den franske inspektionsrapport af 2. juli 2014, som GVK Bio besvarede den 18. juli 2014, og af den endelige inspektionsrapport, der blev udstedt den 21. juli 2014: Der blev konstateret datamanipulation af elektrokardiogrammer (EKG) i hver enkelt af de ni undersøgelser, der blev inspiceret af ANSM.
English: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma and Labesfal Genéricos (for Alendronate);
Danish: Ranbaxy, Basics GmbH, Takeda Belgium, Pensa Pharma and Labesfal Genéricos (for alendronat)
English: Dr. Reddy's Laboratories (UK) Ltd and betapharm Arzneimittel GmbH (for Dipyridamole and Levetiracetam);
Danish: Dr. Reddy's Laboratories (UK) Ltd og betapharm Arzneimittel GmbH (for dipyridamol og levetiracetam)
English: • The Committee reviewed all available data and information provided by the MAHs, as well as information provided by GVK Bio;
Danish: • Udvalget gennemgik alle foreliggende data og oplysninger fra indehaverne af markedsføringstilladelse samt oplysninger fra GVK Bio.
English: Importance of alendronate therapy for patients: The MAHs argue on the importance of the alendronate therapy for patients and continuous availability of the medicine to safeguard public health.
Danish: Vigtigheden af behandlingen med alendronat for patienterne: Indehaverne af markedsføringstilladelse påberåber sig vigtigheden af behandlingen med alendronat for patienterne og den fortsatte rådighed over lægemidlet til beskyttelse af den offentlige sundhed.
English: The CHMP was asked to assess the potential impact of the findings on the benefit risk balance of products authorised on the basis of studies with clinical activities performed at the inspection site.
Danish: CHMP blev anmodet om at vurdere de mulige konsekvenser af inspektionsresultaterne for benefit/risk-forholdet for lægemidler, der er godkendt på grundlag af undersøgelser, hvor de kliniske aktiviteter var udført på inspektionsstedet.
English: In the light of these uncertainties and consequent potential efficacy, safety and tolerability concerns, the benefit-risk balance of the concerned medicinal products is not positive.
Danish: På baggrund af disse usikkerheder og de deraf følgende betænkeligheder vedrørende virkning, sikkerhed og tolerabilitet er benefit/riskforholdet for de pågældende lægemidler ikke positivt.
English: Neo-Balkanika submitted the bioequivalence study (PK-05-035) which had already been submitted during the referral procedure in support of marketing authorisations for Nebivolol 5 mg tablets, with the same qualitative and quantitative composition and same manufacturers.
Danish: Neo-Balkanika fremlagde den bioækvivalensundersøgelse (PK-05-035), der allerede var indsendt under indbringelsesproceduren som dokumentation for markedsføringstilladelserne for Nebivolol, tabletter, 5 mg, der har samme kvalitative og kvantitative sammensætning og samme fremstillere.
English: A biowaiver for a lower strength is not acceptable, as comparative dissolution according to bioequivalence guideline were not submitted.
Danish: Afkald på bioækvivalensundersøgelse for en lavere styrke kan ikke godtages, da der ikke er forelagt en sammenlignende opløselighedsprøve i henhold til retningslinjerne for bioækvivalensundersøgelser.
English: The test product was expired at the time of study.
Danish: Det testede lægemiddel havde overskredet udløbsdatoen på tidspunktet for undersøgelsen.
English: • Re-examination request for Levetiracetam and Dipyridamole:
Danish: • Anmodning om fornyet overvejelse for levetiracetam og dipyridamol:
English: Heumann Pharma GmbH & co. Generica KG, and Torrent Pharma GmbH / Torrent Pharma SRL (for Irbesartan/hydrochlorothiazide and Irbesartan);
Danish: Heumann Pharma GmbH & co. Generica KG og Torrent Pharma GmbH / Torrent Pharma SRL (for irbesartan/hydrochlorothiazid og irbesartan)
English: Finally, The CHMP determined that GVK Bio did not provide evidence to demonstrate that the problem was confined to a specific time period or specific clinical trials or specific individuals and clinical activities.
Danish: Endelig fastslog CHMP, at GVK Bio ikke fremlagde dokumentation for, at problemet var begrænset til en bestemt periode, bestemte kliniske undersøgelser eller bestemte personer og kliniske aktiviteter.
English: Following the adoption of the CHMP opinion during the January 2015 CHMP meeting, requests for re-examination were received from the following MAHs:
Danish: Efter vedtagelsen af CHMP's udtalelse på udvalgets møde i januar 2015 indkom der anmodninger om fornyet overvejelse fra følgende indehavere af markedsføringstilladelse:
English: • Concluded that the benefit risk of Nebivolol/Neo Balkanika is positive, therefore Nebivolol/Neo Balkanika is included in the list of medicinal products recommended for maintenance of the marketing authorisation;
Danish: • at benefit/risk-forholdet for Nebivolol/Neo Balkanika er positivt, hvorfor Nebivolol/Neo Balkanika er opført på listen over lægemidler, for hvilke opretholdelsen af markedsføringstilladelsen er godkendt,
English: The seriousness of the deficiencies identified and the lack of GCP compliance at GVK Bio's clinic in Hyderabad raise questions as to the reliability of studies conducted between 2008 and 2014 at the site inspected, as well as the clinical part of all other bioequivalence trials performed prior to 2008.
Danish: Alvorligheden af manglerne og uoverensstemmelsen med GCP på GVK Bio's klinik i Hyderabad rejser tvivl om pålideligheden af de undersøgelser, der er udført på det inspicerede center mellem 2008 og 2014, og af den kliniske del af alle andre bioækvivalensundersøgelser, der er udført før 2008.
English: • Request for re-examination for Irbesartan and Irbesartan/hydrochlorothiazide:
Danish: • Anmodning for fornyet overvejelse for irbesartan og irbesartan/hydrochlorthiazid:
English: Further to the assessment, the CHMP noted that medicinal products containing Pravastatin were to be excluded of this procedure as out of the scope of the procedure.
Danish: I fortsættelse af vurderingen bemærkede CHMP, at lægemidler indeholdende pravastatin ikke var omhandlet af denne procedure, da de faldt uden for procedurens anvendelsesområde.