FrancophonIA/ELRC3.0 huggingface dataset:
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækningen af ansøgningen, kan ses under "All documents".
English: It is expected to counterbalance the effect of Naproxen of increasing blood pressure.
Danish: Det forventes at opveje virkningen af Naproxen med hensyn til stigende blodtryk.
English: Beprana is a medicine that contains the active substance naproxcinod.
Danish: Beprana er et lægemiddel, der indeholder det aktive stof naproxcinod.
English: What was Beprana expected to be used for?
Danish: Hvad forventedes Beprana anvendt til?
English: By reducing the production of prostaglandins, Beprana is expected to reduce the inflammation and pain seen in osteoarthritis.
Danish: Ved at reducere produktionen af prostaglandiner forventes Beprana at reducere den inflammation og smerte, der optræder ved osteoarthritis.
English: The active substance in Beprana, naproxcinod, is converted in the body into the drug naproxen and a chemical that releases nitric oxide.
Danish: Det aktive stof i Beprana, naproxcinod, omdannes i kroppen til stoffet naproxen og et kemikalie, der frigiver nitrogenoxid.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Danish: Det virker ved at blokere et enzym kaldet cyclooxygenase, som danner prostaglandiner, der indgår i betændelsesprocessen.
English: Three main studies in patients were carried out, comparing Beprana with naproxen (another medicine used in osteoarthritis) and placebo (a dummy treatment).
Danish: Der blev gennemført tre hovedundersøgelser af patienter, hvor Beprana blev sammenlignet med naproxen (et andet lægemiddel til behandling af osteoarthritis) og placebo (en virkningsløs behandling).
English: How is Beprana expected to work?
Danish: Hvordan forventes Beprana at virke?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som i øjeblikket deltager i kliniske undersøgelser med Beprana.
English: On 19 April 2011, NicOx S. A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Beprana in adults for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Danish: Den 19. april 2011 meddelte NicOx S. A. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Beprana til voksne til lindring af tegn og symptomer på osteoarthritis i knæ og hofter.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Beprana could not have been approved for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Beprana ikke kunne være blevet godkendt til lindring af tegn og symptomer på osteoarthritis i knæ og hofter.
English: Beprana was expected to be used to relieve the signs and symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults.
Danish: Beprana forventedes anvendt til lindring af tegn og symptomer på osteoarthritis (hævelser og smerter i leddene) i knæ og hofter hos voksne.
English: The CHMP noted that while there was evidence showing that Beprana was effective in relieving the signs and symptoms of osteoarthritis of the knee and hip, its benefits were not sufficient to outweigh the identified risks.
Danish: CHMP bemærkede, at selv om der var dokumentation for, at Beprana var effektivt med hensyn til lindring af tegn og symptomer på osteoarthritis i knæ og hofter, opvejede fordelene ved Beprana ikke risiciene.
English: Nitric oxide is a vasodilator, a substance that causes the widening of blood vessels.
Danish: Nitrogenoxid er et karudvidende middel, der får blodkarrene til at udvide sig.
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 Beprana eller i programmer for anvendelse af Beprana med særlig udleveringstilladelse?
English: Withdrawal of the marketing authorisation application for Beprana (naproxcinod) EMA/364651/2011
Danish: EMA/364651/2011
English: It is available as capsules (1.5, 3, 4.5 and 6 mg).
Danish: Det fås som kapsler (1,5, 3, 4,5 og 6 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Actavis on 16 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmin Actavis den 16. juni 2011.
English: Rivastigmine Actavis should be given twice a day, with morning and evening meals.
Danish: Rivastigmin Actavis skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
English: The full EPAR for Rivastigmine Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rivastigmin Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Actavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmin Actavis.
English: EMEA/H/C/002036
Danish: EMA/383424/2015 EMEA/H/C/002036
English: Rivastigmine Actavis EMA/463551/2015
Danish: Rivastigmin Actavis EMA/383424/2015
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine Actavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Rivastigmin Actavis.
English: This means that Rivastigmine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Danish: Det betyder, at Rivastigmin Actavis er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Exelon.
English: For more information about treatment with Rivastigmine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rivastigmin Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Actavis by the patient.
Danish: Behandlingen bør kun indledes, hvis der forefindes en plejer, som regelmæssigt overvåger patientens anvendelse af Rivastigmin Actavis.
English: The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Danish: For at få størst mulig gavnlig virkning bør der anvendes den højeste dosis, som patienten tåler, men dosen må ikke overstige 6 mg to gange dagligt.
English: Treatment with Rivastigmine Actavis should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandlingen med Rivastigmin Actavis bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom eller demens hos patienter med Parkinsons sygdom.
English: Other information about Rivastigmine Actavis
Danish: Andre oplysninger om Rivastigmin Actavis
English: The Committee recommended that Rivastigmine Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Rivastigmin Actavis.
English: Rivastigmine Actavis is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmin Actavis anvendes til behandling af patienter med let til middelsvær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: The CHMP concluded that, in accordance with EU requirements, Rivastigmine Actavis has been shown to have comparable quality and to be bioequivalent to Exelon.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Rivastigmin Actavis er af sammenlignelig kvalitet og er bioækvivalent med Exelon.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Danish: Rivastigmin virker ved at blokere de enzymer, der nedbryder acetylcholin:acetylcholinesterase og butyrylcholinesterase.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Danish: Hos patienter, der tåler denne dosis, kan dosen øges i trin på 1,5 mg med mindst to ugers mellemrum, indtil en fast dosis på 3 til 6 mg to gange dagligt er nået.
English: What are the benefits and risks of Rivastigmine Actavis?
Danish: Hvilke fordele og risici er der forbundet med Rivastigmin Actavis?
English: Rivastigmine Actavis is a ‘generic medicine'.
Danish: Rivastigmin Actavis er et ‘generisk lægemiddel'.
English: It can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Det anvendes også til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: The active substance in Rivastigmine Actavis, rivastigmine, is a dementia medicine.
Danish: Det aktive stof i Rivastigmin Actavis, rivastigmin, er et lægemiddel mod demens.
English: Rivastigmine Actavis is a medicine containing the active substance rivastigmine.
Danish: Rivastigmin Actavis er et lægemiddel, som indeholder det aktive stof rivastigmin.
English: Because Rivastigmine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Rivastigmin Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Rivastigmine Actavis rivastigmine
Danish: Rivastigmin Actavis rivastigmin
English: Because Rivastigmine Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Danish: Da Rivastigmin Actavis er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Exelon.
English: Why has Rivastigmine Actavis been approved?
Danish: Hvorfor blev Rivastigmin Actavis godkendt?
English: How has Rivastigmine Actavis been studied?
Danish: Hvordan blev Rivastigmin Actavis undersøgt?
English: How is Rivastigmine Actavis used?
Danish: Hvordan anvendes Rivastigmin Actavis?
English: What is Rivastigmine Actavis used for?
Danish: Hvad anvendes Rivastigmin Actavis til?
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to increase in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Rivastigmin Actavis hjernens indhold af acetylcholin.
English: What is Rivastigmine Actavis?
Danish: Hvad er Rivastigmin Actavis?
English: How does Rivastigmine Actavis work?
Danish: Hvordan virker Rivastigmin Actavis?
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle betingelser eller begrænsninger vedrørende sikker og effektiv anvendelse af lægemidlet som beskrevet ovenfor er blevet implementeret.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Danish: • oplysning om potentielle risici ved administration - herunder overdosering og underdosering samt at utilsigtet intratekal administration har ført til dødsfald
English: Prior to launch of Velcade 3.5mg new dual route of administration (subcutaneous and intravenous) package, in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Danish: Før lanceringen af den nye pakning med VELCADE 3,5 mg til to administrationsveje (subkutan og intravenøs) i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsespakken.
English: • Velcade 3.5mg can be administered both intravenously and subcutaneously while Velcade 1mg can be administered only intravenously
Danish: • at VELCADE 3,5 mg kan administreres enten intravenøst eller subkutant, mens VELCADE 1 mg kun må administreres intravenøst
English: • that Velcade 1mg is only for IV use
Danish: • at VELCADE 1 mg kun er til i.v.
English: The MAH shall ensure that, at launch of Velcade 3.5mg new dual route package and thereafter, all healthcare professionals involved in the prescribing, dispensing, handling or administration of Velcade 3.5mg are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at læger og sundhedspersonale, der beskæftiger sig med ordination, udlevering, håndtering eller administration af VELCADE 3,5 mg, forsynes med uddannelsespakken fra og med lanceringen af den nye pakning med VELCADE 3,5 mg til to administrationsveje.
English: • different reconstitution requirements for Velcade 3.5mg IV or SC use
Danish: • at kravene til rekonstitution af VELCADE 3,5 mg er forskellige ved i.v.
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas.
Danish: • vejledning i dosering med eksempler: Sådan beregnes patientens legemsoverflade og den nødvendige volumen rekonstitueret VELCADE (både til i.v.
English: • SmPC
Danish: og s.c. anvendelse
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Danish: og s.c. anvendelse) til forskellige arealer af legemsoverfladen (krydshenvisning til regnestok)
English: Dosing Slide Rule shall contain the following key elements:
Danish: Regnestokken skal indeholde følgende hovedpunkter:
English: This close-knit network has been strengthened in recent years.
Danish: Dette tætte netværk er blevet styrket i de seneste år.
English: On behalf of the Management Board, I would like to emphasise a couple of events that took place last year.
Danish: Jeg vil på bestyrelsens vegne gerne fremhæve et par af de begivenheder, der fandt sted sidste år.
English: It is a pleasure for me, at this point, to congratulate him and wish him every success in his further term of office.
Danish: Det er mig en glæde at overbringe ham mine lykønskninger med udnævnelsen og ønske ham held og lykke i hans fremtidige virke.
English: In addition to these notifications, the Agency received over 1,000 notifications of changes.
Danish: Udover disse anmeldelser modtog agenturet desuden mere end 1 000 anmeldelser af ændringer.
English: 7 SUPPORT TO SMALL AND MEDIUM-SIZED ENTERPRISES
Danish: 7 STØTTE TIL SMÅ OG MELLEMSTORE VIRKSOMHEDER
English: OJ L 136, 30.04.2004, p. 1.
Danish: EFT L 136 af 30.04.2004, s. 1.
English: 9 INFORMATION AND COMMUNICATION
Danish: 9 INFORMATION OG KOMMUNIKATION
English: 12 COORDINATION GROUPS FOR THE MUTUAL RECOGNITION PROCEDURE AND THE DECENTRALISED PROCEDURE
Danish: 12 KOORDINATIONSGRUPPER FOR DEN GENSIDIGE ANERKENDELSESPROCEDURE OG DEN DECENTRALISEREDE PROCEDURE
English: Ultimate responsibility for the Agency's operational work rests with the Executive Director.
Danish: Det endelige ansvar for agenturets operationelle arbejde påhviler den administrerende direktør.
English: The full annual report 2005 in English can be found on the Agency's website: www.emea.eu.int
Danish: Den fulde årsberetning på engelsk kan ses på agenturets websted: www.emea.eu.int
English: The Committee focused on work to establish the necessary procedures for conducting its business.
Danish: Udvalget koncentrerede sig om at fastlægge de nødvendige procedurer for sit arbejde.
English: Working with national competent authorities
Danish: Samarbejdet med de nationale kompetente myndigheder
English: 1 IMPLEMENTATION OF THE REVISED LEGISLATION
Danish: 1 GENNEMFØRELSE AF DEN REVIDEREDE LOVGIVNING
English: This document provides a summary of the Agency's annual report for 2005, adopted by the Management Board on 9 March 2006.
Danish: Dette dokument indeholder et sammendrag af agenturets årsberetning for 2005 vedtaget af bestyrelsen den 9. marts 2006.
English: There were no negative opinions.
Danish: Der var ingen negative udtalelser.
English: The scheme will only become fully operational once the guidelines on adaptation of data requirements become available.
Danish: Ordningen bliver først fuldt funktionsdygtig, når retningslinjerne om tilpasning af datakravene bliver tilgængelige.
English: A number of meetings were held with companies ahead of possible future applications.
Danish: Der blev afholdt en række møder med firmaer forud for indgivelsen af mulige fremtidige ansøgninger.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tlf.: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
English: This number includes reports originating in the EU and in countries outside the EU, such as the United States.
Danish: Disse indberetninger omfatter såvel indberetninger fra EU som fra lande uden for EU, som f.eks. USA.
English: I would also like to thank the secretariat of the Management Board for their constructive and outstanding collaboration throughout the year.
Danish: Jeg vil også gerne takke bestyrelsen for det konstruktive og fremragende samarbejde i løbet af året.
English: A total of 1,213 applications were received, which represents a 10% increase compared to 2004.
Danish: I alt blev der modtaget 1 213 ansøgninger, hvilket svarer til en stigning på 10 % i forhold til 2004.
English: Lastly, I extend my wholehearted thanks to all EMEA staff, whose tireless efforts throughout this challenging year resulted in such a positive outcome for the Agency.
Danish: Til sidst vil jeg gerne rette en dybfølt tak til alle EMEA-ansatte, hvis utrættelige anstrengelser i løbet af dette udfordringernes år resulterede i så positive resultater for agenturet.
English: 10 CONTRIBUTION TO EU PUBLIC HEALTH STRATEGIES
Danish: 10 BIDRAG TIL EU'S FOLKESUNDHEDSSTRATEGIER
English: Altogether, 238 deaths in animals were reported.
Danish: Der blev i alt rapporteret om 238 dødsfald blandt dyr.
English: New applications for veterinary medicines received/forecast (Input)
Danish: Nye ansøgninger om veterinærlægemidler modtaget/forventet (input)
English: The Agency looked again at the safety of Micotil, following a request by the European Commission to take into account new information.
Danish: Agenturet undersøgte endnu engang sikkerheden ved Micotil efter en opfordring fra EuropaKommissionen til at medregne nye oplysninger.
English: It provided support to the European Commission with the technical requirements for such products, and will continue to do so as necessary during the Council and European Parliament consultation process.
Danish: Det støttede Europa-Kommissionen med de tekniske krav til disse produkter, hvilket det om nødvendigt agter at fortsætte med under Rådets og Europa-Parlamentets høringsproces.
English: The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products.
Danish: Den decentraliserede procedure og den gensidige anerkendelsesprocedure anvendes for størsteparten af de traditionelle lægemidler.
English: 2 IMPLEMENTATION OF THE ROAD MAP
Danish: 2 GENNEMFØRELSE AF KØREPLANEN
English: A total of 34,352 ICSRs relating to SUSARs were received.
Danish: Der blev i alt modtaget 34 352 ICSR vedrørende SUSAR.
English: Those ten years of continuous growth and consolidation gave the Agency the experience and confidence it needed to meet the greatest challenge it has had to face so far: the full entry into force of the revised EU pharmaceutical legislation, in November 2005.
Danish: Disse ti år med vedvarende vækst og konsolidering gav agenturet den erfaring og tillid, som var nødvendig for at tage den hidtil største udfordring op, nemlig den fuldstændige ikrafttræden af den reviderede EU-lægemiddellovgivning i november 2005.
English: I am particularly grateful for the excellent participation of our partners from the new Member States, in what was the first full year of operation in a European Union of 25 nations.
Danish: Jeg sætter især pris på det særdeles store engagement, som vore partnere fra de nye medlemsstater lagde for dagen i det første hele år, hvor Den Europæiske Union fungerede med 25 nationer.
English: The information updates published on the EMEA website relating to these issues have been acclaimed as extremely useful.
Danish: De ajourførte oplysninger om disse emner, som er offentliggjort på EMEA's webside, er blevet hilst velkommen som værende yderst nyttige.
English: Administrative and procedural assistance from the SME Office at the Agency
Danish: Administrativ og proceduremæssig bistand fra agenturets SMV-kontor.
English: Thanks to the excellent planning and preparations put in place during the run-up to that date, the Agency was able to successfully implement all relevant provisions and guidelines stemming from the new legislation.
Danish: Takket være den særdeles gode planlægning og forberedelserne i tiden frem til denne dato var agenturet i stand til med held at gennemføre alle de relevante bestemmelser og retningslinjer, som var et resultat af den nye lovgivning.
English: Integrated quality management system
Danish: Integreret kvalitetsstyringssystem
English: 11 PREPARATION FOR NEW TYPES OF APPLICATIONS
Danish: 11 FORBEREDELSE TIL NYE FORMER FOR ANSØGNINGER
English: Extensions of use for children: 4 products had their use extended to include the treatment of children.
Danish: Udvidelse af brugen til børn: Fire produkter fik udvidet deres anvendelsesområde til at omfatte behandling af børn.
English: The results presented in this Annual Report prove that the EMEA ably faced up to its many challenges in 2005.
Danish: De resultater, der fremlægges i denne årsberetning, viser, at EMEA til fulde formåede at leve op til de mange udfordringer i 2005.
English: 5.2 Product defects and deviations
Danish: 5.2 Produktfejl og afvigelser