FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types.
Danish: CHMP fandt, at Gardasil 9 giver bredere beskyttelse mod kræft end sin forløber Gardasil, da det beskytter mod yderligere fem typer HPV (31, 33, 45, 52 og 58), som også anses for at medføre høj risiko for HPV, selv om de er mindre udbredt end type 16 og 18.
English: This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil.
Danish: I undersøgelsen fik en ud af de 6 016 kvinder, der var vaccineret med tre doser Gardasil 9, sygdom knyttet til HPV type 31, 33, 45, 52 og 58, sammenholdt med 30 ud af of 6 017 kvinder, der var vaccineret med tre doser Gardasil.
English: The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18).
Danish: I undersøgelsen blev det registreret, hvor mange kvinder vaccineret med Gardasil 9, der fik sygdom (udvækster eller kræft) forårsaget af HPV type 31, 33, 45, 52 og 58, sammenlignet med dem, der var vaccineret med Gardasil (en allerede godkendt vaccine, der beskytter mod type 6, 11, 16 og 18).
English: It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine.
Danish: Efter den første dosis Gardasil 9 anbefales det at fuldføre behandlingen med samme lægemiddel.
English: Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.
Danish: Gardasil 9 kan beskytte mod alle ni typer HPV-infektion.
English: How is Gardasil 9 used?
Danish: Hvordan anvendes Gardasil 9?
English: What benefits of Gardasil 9 have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Gardasil 9?
English: How does Gardasil 9 work?
Danish: Hvordan virker Gardasil 9?
English: Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as ‘recombinant DNA technology'.
Danish: Gardasil 9 indeholder rensede L1-proteiner fra de ni ovennævnte HPV-typer.
English: The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.
Danish: Det blev påvist, at piger vaccineret med Gardasil 9 havde samme niveau af beskyttelse mod type 6, 11, 16 og 18 som piger, der var vaccineret med Gardasil.
English: Gardasil 9 is a suspension for injection available in vials or prefilled syringes.
Danish: Gardasil 9 fås som injektionsvæske, suspension, i hætteglas og fyldte sprøjter.
English: The study should be conducted in more than one Member State.
Danish: Undersøgelsen skal udføres i mere end én medlemsstat.
English: The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC:
Danish: Protokollen skal forelægges i overensstemmelse med artikel 107n, stk. 1), i direktiv 2001/83/EF:
English: Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years.
Danish: Yderligere interimsrapporter indsendes derefter til PRAC hver sjette måned i de første 2 år.
English: Within 6 months of the Coordination group agreement.
Danish: Senest 6 måneder efter at koordinationsgruppen er nået til enighed
English: The final study report shall be submitted to the PRAC:
Danish: Den endelige undersøgelsesrapport indsendes til PRAC:
English: The first interim report shall be submitted to the PRAC :
Danish: Den første interimsrapport indsendes til PRAC:
English: National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten (-staterne) eller i givet fald i referencemedlemsstaten (-staterne) sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in utero exposure.
Danish: Dette materiale skal sikre, at den ordinerende læge informeres om og patienterne får kendskab til og erkender de risici, der forbundet med eksponeringen for valproat in utero.
English: The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements.
Danish: Indehaverne af markedsføringstilladelse for valproat og relaterede stoffer udarbejder og indsender oplysningsmateriale svarende til de vedtagne hovedelementer.
English: The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Danish: Indehaverne af markedsføringstilladelse for valproat og relaterede stoffer udfører en undersøgelse af lægemiddelanvendelse til vurdering af effektiviteten af risikominimeringsforanstaltningerne og til yderligere karakterisering af ordinationsmønstrene for valproat.
English: The study design should aim to evaluate and quantify the effectiveness of the risk minimisation measures, and should include a pre- and postimplementation analysis and assessment.
Danish: Undersøgelsen skal være udformet med henblik på at vurdere og kvantificere effektiviteten af risikominimeringsforanstaltningerne og skal analysere og vurdere forholdene før og efter implementering.
English: These should be submitted to the National Competent Authorities: By 12 January 2015
Danish: Senest den 12. januar
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administrationsve j
English: Concentrate for solution for intraocular irrigation
Danish: Koncentrat til intraokulær skyllevæske, opløsning
English: 10 (1 x 10) vial (multipack)
Danish: Intraokulær anvendelse hætteglas (glas) 10 (1 x 10) hætteglas (multipakning)
English: 28 March 2014
Danish: Den 28. marts 2014
English: The revised opinion was converted into a Decision by the European Commission on 28 March 2014.
Danish: Den reviderede udtalelse blev den 28. marts 2014 omarbejdet til en beslutning af EuropaKommissionen.
English: International non-proprietary name (INN): barium selenate
Danish: Internationalt fællesnavn (INN): bariumselenat
English: The re-examination procedure started on 11 June 2013.
Danish: Den fornyede overvejelsesprocedure blev indledt den 11. juni 2013.
English: On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment.
Danish: Den 23. august 2013 anmodede Europa-Kommissionen CVMP om fornyet overvejelse af sin udtalelse, hovedsagelig med henblik på præcisering af visse aspekter vedrørende vurderingen af risikoen for forbrugerne.
English: Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
Danish: Ansøgerne og indehaverne af markedsføringstilladelse fremsendte skriftlige redegørelser den 14. november 2011 og den 30. november 2012.
English: The referral started on 15 September 2011.
Danish: Henvisningsproceduren blev indledt den 15. september 2011.
English: EMA/197955/2014 Veterinary Medicines
Danish: EMA/197955/2014
English: During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.
Danish: På sit møde den 14.-16. maj 2013 udpegede CVMP K. Törneke som rapportør og K. Baptiste som medrapportør for den fornyede overvejelsesprocedure.
English: An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.
Danish: Ansøgerne/indehaverne af markedsføringstilladelse afgav en mundtlig redegørelse den 6. marts 2013.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013.
Danish: Den samlede detaljerede begrundelse for fornyet overvejelse blev indgivet af Cross Vetpharm Group Limited og Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) den 10. juni 2013.
English: On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species.
Danish: Den 14. september 2011 foretog Tyskland en indbringelse for agenturet i henhold til artikel 35 i direktiv 2011/82/EF for alle depotinjektionspræparater indeholdende bariumselenat til alle arter til levnedsmiddelproduktion.
English: Opinion following an Article 350F referral for long-acting formulations for injection containing barium selenate for all food producing species EMA/197955/2014
Danish: Udtalelse efter en artikel 350F-indbringelse vedrørende depotinjektionspræparater indeholdende bariumselenat til alle arter bestemt til levnedsmiddelproduktion EMA/197955/2014
English: The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products.
Danish: Udvalget vedtog derfor den 10. april 2013 ved en flertalsafgørelse en negativ udtalelse med anbefaling om suspendering af markedsføringstilladelserne for alle berørte produkter.
English: On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013.
Danish: Den 26. april 2013 anmodede Cross Vetpharm Group Limited og Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) agenturet om fornyet overvejelse af CVMP's udtalelse af 10. april 2013.
English: Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenatecontaining injectable veterinary medicinal products.
Danish: Tyskland indbragte sagen for CVMP på grund af alvorlig bekymring for menneskers sundhed ved eksponering for restkoncentrationer fra injektionsstedet af depotinjektionsvæsker indeholdende bariumselenat til veterinær anvendelse.
English: Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health.
Danish: Efter vurdering af de foreliggende data fandt CVMP, at benefit/risk-forholdet for de berørte veterinærlægemidler var negativt, eftersom bariumselenat persisterede for lang tid på injektionsstedet efter behandling med de anbefalede doser, hvorfor indtagelse af rester fra injektionsstedet kan udgøre en væsentlig risiko for menneskers sundhed.
English: On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.
Danish: Den 6. november 2013 vedtog CVMP ved en flertalsafgørelse en revideret udtalelse, der bekræftede anbefalingen i udvalgets udtalelse af 17. juli 2013 om, at benefit/risk-forholdet for de berørte veterinærlægemidler var negativt, hvorfor CVMP anbefalede afslag på ansøgning om udstedelse af markedsføringstilladelse og suspendering af de eksisterende markedsføringstilladelser for de berørte produkter.
English: On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.
Danish: Den 17. juli 2013 vedtog CVMP ved en flertalsafgørelse en udtalelse, der fastholdt anbefalingen om suspendering af markedsføringstilladelserne for de berørte veterinærlægemidler.
English: Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Danish: Bariumselenat har været anvendt i veterinære depotinjektionsvæsker til behandling og forebyggelse af selenmangel hos kvæg og får.
English: Opinion following an Article 351 referral for long-acting formulations for injection containing barium selenate for all food producing species
Danish: 1-indbringelse vedrørende depotinjektionspræparater indeholdende bariumselenat til alle arter bestemt til levnedsmiddelproduktion
English: 29 January 2016
Danish: 04. april 2016
English: What are the conclusions of the CHMP?
Danish: Hvilke konklusioner har CHMP draget?
English: On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB.
Danish: Den 28. januar 2015 gennemførte Det Europæiske Lægemiddelagentur (EMA) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Tobramycin VVB.
English: However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den litauiske lægemiddelstyrelse indbragte sagen for CHMP med henblik på voldgift den 14. oktober 2015.
English: EMEA/H/A-29/1428
Danish: EMA/55653/2016 Rev.1 EMEA/H/A-29/1428
English: What is Tobramycin VVB?
Danish: Hvad er Tobramycin VVB?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Tobramycin VVB kan få markedsføringstilladelse i Litauen og i følgende EUmedlemsstater: Bulgarien, Estland, Ungarn, Letland, Polen og Rumænien.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.
Danish: Stoffet virker ved at forstyrre produktionen af de proteiner, som P. aeruginosa har brug for til at bygge cellevægge, og dét beskadiger bakterien tilstrækkeligt til, at den til sidst dør.
English: Why was Tobramycin VVB reviewed?
Danish: Hvorfor blev Tobramycin VVB undersøgt?
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB.
Danish: På grundlag af evalueringen af de aktuelt tilgængelige data og den videnskabelige diskussion i udvalget, konkluderede CHMP, at Tobramycin VVB er klinisk bedre end Tobi Podhaler, da en væsentlig andel af patienterne ikke kan tåle Tobi Podhaler, men godt kan tåle behandling med Tobramycin VVB.
English: The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States.
Danish: CHMP anbefaler derfor, at Tobramycin VVB bliver godkendt til markedsføring i Litauen og i de øvrige berørte medlemsstater.
English: Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011.
Danish: Det er nødvendigt at påvise en klinisk bedre virkning, fordi Tobi Podhaler er et lægemiddel til sjældne sygdomme, der fik eksklusiv ret i EU, da det blev markedsgodkendt i juli 2011.
English: Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis.
Danish: Tobramycin VVB er et antibiotikum til behandling af langvarig lungeinfektion forårsaget af bakterien Pseudomonas aeruginosa hos patienter i alderen 6 år og derover, som har cystisk fibrose.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections.
Danish: Cystisk fibrose er en arvelig sygdom, der giver ophobning af tyk slim i lungerne; ophobningen af slim gør det lettere for bakterier at formere sig, så der opstår infektioner.
English: The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Danish: Det aktive stof i Tobramycin VVB, tobramycin, tilhører en gruppe af antibiotika kaldet aminoglykosider.
English: The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin.
Danish: Grunden til sagsindbringelsen var en uoverensstemmelse om, hvorvidt Tobramycin VVB er klinisk bedre end Tobi Podhaler, et andet lægemiddel indeholdende tobramycin.
English: A European Commission decision on this opinion will be issued in due course.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 04. april 2016.
English: UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure.
Danish: UAB VVB søgte Tobramycin VVB godkendt af den litauiske lægemiddelstyrelse ved en decentral procedure.
English: This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
Danish: Det betyder, at lignende produkter, f.eks. Tobramycin VVB, ikke må markedsføres i den periode, hvor Tobi Podhaler har eksklusiv ret. Der er dog en række undtagelser, f.eks. hvis det kan påvises, at et andet lægemiddel har en bedre virkning end Tobi Podhaler.
English: Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Danish: Tobramycin VVB er en "hybridmedicin", hvilket betyder, at den er udviklet til at være sammenlignelig med et "referencelægemiddel", der indeholder tobramycin, og som hedder Tobi (300 mg/5 ml inhalationsvæske til nebulisator).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom land foruden i andre medlemsstater (de "berørte medlemsstater", her Bulgarien, Estland, Ungarn, Letland, Polen og Rumænien).
English: Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled.
Danish: Tobramycin VVB fås som inhalationsvæske til nebulisator (300 mg/5 ml).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Litauen) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende
English: budesonide / formoterol
Danish: budesonid / formoterol
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det er påvist, at Budesonide/Formoterol Teva Pharma B.V., 160/4,5 µg og 320/9 µg, har en kvalitet som Symbicort Turbohaler og en virkning som de tilsvarende styrker af Symbicort Turbohaler.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva Pharma B.V., including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Budesonide/Formoterol Teva Pharma B.V., herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For more information about treatment with Budesonide/Formoterol Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Budesonide/Formoterol Teva Pharma B.V., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder de samme aktive stoffer, men til Budesonide/Formoterol Teva Pharma B.V.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: 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 Budesonide/Formoterol Teva Pharma B.V.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Budesonide/Formoterol Teva Pharma B.V..
English: The two active substances in Budesonide/Formoterol Teva Pharma B.V. are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Danish: er velkendte og findes i flere lægemidler, der anvendes til behandling af astma, enten alene eller i kombination med andre lægemidler.
English: For practical information about using Budesonide/Formoterol Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Budesonide/Formoterol Teva Pharma B.V., kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Studies were carried out to show that Budesonide/Formoterol Teva Pharma B.V. is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Danish: frembringer samme mængde aktivt stof i kroppen som referencelægemidlet (dvs. det er bioækvivalent med referencelægemidlet), og at de to lægemidler virker på samme måde.