FrancophonIA/ELRC3.0 huggingface dataset:
English: The amendments concern the following areas: inspections, plasma master files, certificates for medicinal products, type II variations to MUMS marketing authorisations for non-food-producing species, and core dossiers for medicinal products to be used in a human pandemic situation.
Danish: Ændringerne vedrørte følgende områder: kontroller, Plasma Master Files (PMF), certifikater for lægemidler, kategori II-ændringer til MUMS-markedsføringstilladelser vedrørende lægemidler til dyr, hvis kød og produkter ikke anvendes til konsum, og centrale dossierer for lægemidler til brug i tilfælde af en human pandemi.
English: The Board discussed the proposal to introduce restrictions in certain cases where potential conflicts of interests can be perceived.
Danish: Bestyrelsen drøftede forslaget om at indføre begrænsninger i tilfælde af potentielle interessekonflikter.
English: A reflection paper on veterinary product supply shortages should be discussed.
Danish: Et arbejdsdokument om manglende forsyninger af lægemidler til dyr burde drøftes.
English: Mary Baker Apologies from Mike O'Donovan
Danish: Mary Baker Afbud fra Mike O'Donovan
English: Members also stressed that the austerity environment should be seen as an opportunity for the whole network to rationalise the way it operates.
Danish: Medlemmerne understregede desuden, at den aktuelle krisesituation burde ses som en lejlighed til at rationalisere driften overalt i netværket.
English: Chair: Sir Kent Woods
Danish: Formand: Sir Kent Woods
English: Pedro Ortun Silvan (DG Enter) gives his vote by proxy to Paola Testori-Coggi (DG Sanco).
Danish: Pedro Ortun Silvan (GD Entr) har givet stemmefuldmagt til Paola Testori-Coggi (GD Sanco).
English: d.) ICT budgets and projects for 2012
Danish: d.) Ikt-budgetter og -projekter i 2012
English: Report from the Heads of Medicines Agencies (HMA)
Danish: Rapport fra cheferne for de nationale lægemiddelstyrelser (HMA)
English: The Board also decided to invite the current civil society representativesMary Baker, Mike O'Donovan and Lisette Tiddens - to participate at the next meeting as observers, to enable them to provide valuable input to the work of the Board.
Danish: Bestyrelsen besluttede også at indbyde de nuværende civilsamfundsrepræsentanter - Mary Baker, Mike O'Donovan og Lisette Tiddens - til at deltage i næste møde som observatører, for at de kunne give bestyrelsen værdifuldt input til dennes arbejde.
English: With regard to this particular concern, the meeting was reminded that the issue was discussed when preparing the experts' policy.
Danish: Med hensyn til netop dette punkt blev medlemmerne mindet om, at emnet var blevet drøftet, da politikken for eksperternes vedkommende blev udformet.
English: European Parliament
Danish: Europa-Parlamentet
English: 11bis Preparation for written procedures: Non-automatic carry-over 2011-2012
Danish: 11a Udarbejdelse af skriftlige procedurer for ikkeautomatiske fremførsler 2011-2012
English: The Board took the opportunity to thank the topic coordinators (Xavier De Cuyper, Walter Schwerdtfeger and Lisette Tiddens) for preparing this topic for the discussion, and will look forward to a further discussion at the next meeting.
Danish: Bestyrelsen benyttede lejligheden til at takke emnekoordinatorerne (Xavier De Cuyper, Walter Schwerdtfeger og Lisette Tiddens) for deres forberedelse af dette emne til drøftelse og glædede sig til den videre drøftelse på næste møde.
English: Vote on the adoption of agenda item 7bis - Personnel matter
Danish: Afstemning om dagsordenens punkt 7c - personaleanliggender
English: • [EMA/876327/2011] EMA preparations for the impact of the Olympic Games 2012.
Danish: • [EMA/876327/2011] EMA's forberedelse af virkningen af de olympiske lege 2012.
English: b.) Second update on the implementation of the conflicts of interests policy for staff
Danish: b.) Anden ajourføring af gennemførelsen af en politik om interessekonflikter for medarbejdere
English: Members raised concern that the legislation does not provide for alternate members of the civil society representatives on the Management Board.
Danish: Der blev udtrykt bekymring over, at det ikke ifølge reglerne var tilladt at have suppleanter for civilsamfundsrepræsentanterne siddende i bestyrelsen.
English: Revised Management Board rules of procedure
Danish: Revideret forretningsorden for bestyrelsen
English: George Antoniou (Cyprus) gives his vote by proxy to Patricia Vella Bonanno (Malta).
Danish: George Antoniou (Cypern) har givet stemmefuldmagt til Patricia Vella Bonanno (Malta).
English: • [EMA/MB/902317/2011] Summary of transfers of appropriations in the budget 2011.
Danish: • [EMA/MB/902317/2011] Sammendrag af bevillingsoverførsler på budgettet for 2011.
English: European Commission Paola Testori Coggi Apologies from Pedro Ortum Silvan
Danish: Europa-Kommissionen Paola Testori Coggi Afbud fra Pedro Ortum Silvan
English: Planning 2012
Danish: Planlægning 2012
English: The Board was informed that the Agency had sent letters to respective Member States' Permanent Representations in Brussels inviting nominations to the Committee with the deadline of 15 January
Danish: Bestyrelsen blev oplyst om, at agenturet havde skrevet til medlemsstaternes faste repræsentation i Bruxelles og opfordret dem til at udpege medlemmer til udvalget.
English: The Management Board thanked the topic coordinators Aginus Kalis, Marcus Müllner, Pat O'Mahony and Kent Woods for their contribution in preparing the topics on the work programme and the budget for the discussion.
Danish: Bestyrelsen takkede emnekoordinatorerne Aginus Kalis, Marcus Müllner, Pat O'Mahony og Kent Woods for deres bidrag til forberedelsen af emnerne i arbejdsprogrammet og budgettet med henblik på drøftelsen heraf.
English: c.) The revised Management Board conflicts of interests policy
Danish: c.) Bestyrelsens reviderede politik om interessekonflikter
English: Against
Danish: Imod
English: a.) The work programme 2012
Danish: a.) Arbejdsprogrammet for 2012
English: • [EMA/907269/2011] EU telematics projects report; [EMA/907270/2011] EU telematics operations report; [EMA/907383/2011] Minutes from the Management Board Telematics Committee meeting held on 22 September 2011.
Danish: • [EMA/907269/2011] Rapport om EU's telematikprojekt; [EMA/907270/2011] Rapport om EU's telematikaktiviteter; [EMA/907383/2011] Referat af mødet i bestyrelsens telematikudvalg, afholdt den 22. september 2011.
English: Ioannis Toutas (Greece) gives his vote by proxy to Pat O'Mahony (Ireland).
Danish: Ioannis Toutas (Grækenland) har givet stemmefuldmagt til Pat O'Mahony (Irland).
English: Proxies announced by the Chair
Danish: Fuldmagter bekendtgjort af formanden
English: This reflection paper focuses only on supply shortages in the area of human medicines.
Danish: Dette arbejdsdokument omhandlede kun manglende forsyninger på området for lægemidler til mennesker.
English: [EMA/MB/902165/2011] The mid-year report showed positive trends in the area of signal detection and management.
Danish: [EMA/MB/902165/2011] Halvårsrapporten viste positive tendenser på området for signalpåvisning og signalstyring.
English: [EMA/MB/826035/2011] The agenda was adopted.
Danish: [EMA/MB/826035/2011] Dagsordenen blev vedtaget.
English: Some of the factors contributing to supply shortages are trade issues, concentration and economics of manufacturing, and the drive for cost savings in healthcare systems.
Danish: Nogle af faktorerne bag forsyningssvigt var handelsrelaterede, nogle handlede om koncentration og fremstillingsøkonomi, og besparelserne i sundhedsvæsnet var også en faktor.
English: b.) MBTC chairmanship arrangements
Danish: b.) Formandskabsordning for MBTC
English: The Board welcomed the framework that aims to strengthen the already existing cooperation with HCPs and to fill remaining gaps.
Danish: Bestyrelsen bifaldt rammen, som skulle styrke det bestående samarbejde med sundhedsfagpersoner og afhjælpe de sidste mangler.
English: [EMA/MB/924270/2011; EMA/914836/2011] This item (for information) was deferred to the next meeting.
Danish: [EMA/MB/924270/2011; EMA/914836/2011] Dette punkt (til orientering) blev udsat til næste møde.
English: 5 Denmark
Danish: 5 Danmark
English: The Board noted the letter from Paola Testori, Director-General of the DG for Health and Consumers, on the subject.
Danish: Bestyrelsen noterede sig brevet om dette emne fra generaldirektør for GD Sundhed og Forbrugere Paola Testori.
English: Claude Hemmer (Luxembourg) gives his vote by proxy to Aginus Kalis (Netherlands).
Danish: Claude Hemmer (Luxembourg) har givet stemmefuldmagt til Aginus Kalis (Nederlandene).
English: Mike O'Donovan gives his vote by proxy to Mary G Baker.
Danish: Mike O'Donovan har givet stemmefuldmagt til Mary G. Baker.
English: Veterinarian organisations
Danish: Veterinærorganisationer
English: • [EMA/MB/868582/2011] Outcome of written procedures during the period 15 September 2011 to
Danish: • [EMA/MB/868582/2011] Resultat af skriftlige procedurer i perioden 15. september 2011 til 30. november 2011.
English: [EMA/MB/882002/2011] The Management Board noted that a written procedure for non-automatic carry-forward will be launched for adoption no later than 15 February 2012.
Danish: [EMA/MB/882002/2011] Bestyrelsen noterede sig, at en skriftlig procedure for ikkeautomatiske fremførsler ville blive forelagt til vedtagelse senest den 15. februar 2012.
English: Annex
Danish: Bilag
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norway)
Danish: Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norge)
English: 6 Estonia
Danish: 6 Estland
English: [EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] The Board discussed the issue of supply shortages, considering it to be of importance to public health.
Danish: [EMA/MB/899250/2011; EMA/INS/GMP/774201/2011] Bestyrelsen drøftede spørgsmålet om manglende forsyninger, som den fandt af betydning for folkesundheden.
English: Vote on the adoption of agenda item 7c - MB conflicts of interests policy
Danish: Afstemning om dagsordenens punkt 7c - bestyrelsens politik om interessekonflikter
English: 3 Belgium
Danish: 3 Belgien
English: 2 Bjorn Lemmer
Danish: 2 Björn Lemmer
English: Members welcomed Guido Rasi, the Executive Director of the Agency, for whom this was the first Management Board meeting in this capacity.
Danish: Medlemmerne bød agenturets administrerende direktør Guido Rasi velkommen.
English: Communication, transparency, future veterinary legislation, interactions with health technology assessment (HTA) bodies, process reengineering to increase efficiency of operations, and assuring functioning of the Agency during the busy Olympic period in London will be other areas of focus for
Danish: Andre fokusområder i 2012 ville blive kommunikation, gennemsigtighed, kommende veterinærlovgivning, samspil med organer for vurdering af sundhedsteknologi (HTA), BPR for at øge agenturets driftseffektivitet og varetagelse af agenturets drift under den travle periode med de olympiske lege i London.
English: e.) Staff policy plan 2012
Danish: e.) Plan for personalepolitikken 2012
English: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] The Management Board endorsed the new framework for interaction with healthcare professionals (HCPs) and the criteria that apply to HCP organisations wishing to be involved in the Agency's activities.
Danish: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] Bestyrelsen godkendte den nye ramme for samspillet med sundhedsfagpersoner (HCP) og kriterierne for sundhedsfaglige organisationer, som ønskede at deltage i agenturets aktiviteter.
English: [EMA/MB/880875/2011] The Management Board endorsed the adaptation of the fixed hourly cost to €41 for the year 2012 (the cost had been €40 since 2009).
Danish: [EMA/MB/880875/2011] Bestyrelsen godkendte ajourføringen af timeprisen for 2012 til 41 EUR (den har været 40 EUR siden 2009).
English: [EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] The Management Board endorsed the IAS strategic audit plan for 2012-2014.
Danish: [EMA/MB/915206/2011; Ares(2011)992230 - 20/09/2011] Bestyrelsen godkendte IAS's strategiske revisionsplan for 2012-2014.
English: [EMA/MB/811207/2011] The Management Board endorsed the report on the Agency's procurement procedure and the proposed improvement action plan.
Danish: [EMA/MB/811207/2011] Bestyrelsen godkendte rapporten om agenturets indkøbsprocedure og forslaget til en forbedringshandlingsplan.
English: c.) Draft budget and establishment plan 2012
Danish: c.) Budgetforslag og stillingsfortegnelse for 2012
English: [EMA/MB/554514/2011] The Management Board adopted the work programme 2012.
Danish: [EMA/MB/554514/2011] Bestyrelsen vedtog arbejdsprogrammet for 2012.
English: • No 11/2011 - the appointment of Frederic Klein as CVMP alternate, proposed by Belgium, finalised on 19 October 2011.
Danish: • Nr. 11/2011 - udnævnelse af Frederic Klein til CVMP-suppleant, indstillet af Belgien, afsluttet den 19. oktober 2011.
English: [EMA/MB/115339/2004/Rev.3] The Management Board adopted changes to the Management Board rules of procedure.
Danish: [EMA/MB/115339/2004/Rev.3] Bestyrelsen vedtog ændringerne af bestyrelsens forretningsorden.
English: [EMA/MB/828587/2011] The Management Board noted the final minutes, adopted by written procedure on 23 November 2011.
Danish: [EMA/MB/828587/2011] Bestyrelsen tog det endelige referat, vedtaget ved skriftlig procedure den 23. november 2011, til efterretning.
English: Representatives of patients' organisations
Danish: Repræsentanter for patientorganisationer
English: • No 10/2011 - the appointment of Eva Persson as CVMP alternate, proposed by Sweden, finalised on 19 October 2011.
Danish: • Nr. 10/2011 - udnævnelse af Eva Persson til CVMP-suppleant, indstillet af Sverige, afsluttet den 19. oktober 2011.
English: • No 12/2011 - the appointment of Alia Michaelidou-Patsia as CVMP alternate, proposed by Cyprus, finalised on 28 November 2011.
Danish: • Nr. 12/2011 - udnævnelse af Alia Michaelidou-Patsia til CVMP-suppleant, indstillet af Cypern, afsluttet den 28. november 2011.
English: [EMA/MB/834867/2011] The Management Board welcomed the proposed revisions to the Management Board policy on conflicts of interests.
Danish: [EMA/MB/834867/2011] Bestyrelsen bifaldt de foreslåede ændringer af bestyrelsens politik om interessekonflikter.
English: [EMA/MB/901680/2011; EMA/901869/2011] The Management Board endorsed the implementing activities for 2012.
Danish: [EMA/MB/901680/2011; EMA/901869/2011] Bestyrelsen godkendte gennemførelsesaktiviteterne for 2012.
English: 1 Giuseppe Nistico
Danish: 1 Giuseppe Nisticó
English: [EMA/MB/856505/2011] The Management Board noted the information on the ICT budget and the projects planned for 2012.
Danish: [EMA/MB/856505/2011] Bestyrelsen noterede sig oplysningen om ikt-budgettet og -projekterne i 2012.
English: [EMA/MB/239263/2011] The Management Board adopted amendments to the fee implementing rules.
Danish: [EMA/MB/239263/2011] Bestyrelsen vedtog ændringerne af gennemførelsesbestemmelserne om gebyrer.
English: [EMA/MB/143451/2011] The Board adopted the Agency's budget and the establishment plan for 2012.
Danish: [EMA/MB/143451/2011] Bestyrelsen vedtog agenturets budget og stillingsfortegnelse for 2012.
English: Pedro Ortun Silvan by proxy
Danish: Pedro Ortun Silvan ved stemmefuldmagt
English: 15 Romania 16 Slovakia 17 Slovenia 18 Sweden 19 United Kingdom 20 Mary Baker 21 Mike O'Donovan by proxy
Danish: 15 Rumænien 16 Slovakiet 17 Slovenien 18 Sverige 19 Det Forenede
English: [EMA/MB/886045/2011; EMA/121340/2011] The Management Board endorsed the reflection paper.
Danish: [EMA/MB/886045/2011; EMA/121340/2011] Bestyrelsen godkendte arbejdsdokumentet.
English: 4 Cyprus by proxy
Danish: 4 Cypern ved stemmefuldmagt
English: [EMA/907384/2011] The Management Board adopted a change to the terms of reference of the Committee.
Danish: [EMA/907384/2011] Bestyrelsen vedtog at ændre udvalgets vedtægter.
English: Kent Woods
Danish: Det Forenede Kongerige Kent Woods
English: Held in London on 15 December 2011
Danish: møde i bestyrelsen afholdt i London den 15. december 2011
English: Minutes of the 74th meeting of the Management Board
Danish: • Vedtagelse af referat af bestyrelsens 73.
English: EMA/MB/33634/2012 Adopted Management Board
Danish: EMA/511055/2012 Vedtaget Bestyrelsen
English: Highlights from the Executive Director
Danish: Den administrerende direktørs redegørelse for de vigtigste begivenheder
English: a.) Revised terms of reference
Danish: a.) Vedtægtsændring
English: Representative of veterinarians' organisations
Danish: Repræsentanter for veterinærorganisationer Observatører
English: The European Commission stated the importance of not raising expectations among the public in view of the resource constraints; the Commission will look at what can be addressed in the revision of the Clinical Trials Directive.
Danish: Europa-Kommissionen anførte, at det var vigtigt, at offentlighedens forventninger ikke blev for høje i forhold til de begrænsede ressourcer.
English: 12 Latvia
Danish: 11 Italien
English: Minutes from the 73rd meeting, held on 6 October 2011
Danish: møde den 6. oktober 2011
English: [EMA/MB/643417/2011] The Management Board noted the revised staff policy plan, in line with the reduced staffing and budget compared to the 2012 preliminary draft budget.
Danish: [EMA/MB/643417/2011] Bestyrelsen tog planen for personalepolitikken til efterretning.
English: 300 mg Concentrate for solution for infusion
Danish: 300 mg koncentrat til infusionsvæske, opløsning
English: Oral suspension Oral use bottle (glass)
Danish: 40 mg/ml Oral suspension Oral anvendelse Flaske (glas) 105 ml
English: Acne affects more than 50% of teenagers but frequently continues into adulthood.
Danish: Acne optræder hos mere end 50 % af alle teenagere, men vedvarer ofte ind i voksenlivet.
English: Scarring can lead to lifelong problems in regard to self-esteem.
Danish: Ardannelse kan føre til livslange selvværdsproblemer.
English: • The Committee considered all the available data submitted from efficacy and safety.
Danish: • Udvalget gennemgik alle foreliggende data vedrørende virkning og sikkerhed.
English: Therefore the Committee concluded that the variation application should be refused.
Danish: Udvalget konkluderede derfor, der burde gives afslag på ændringsansøgningen.
English: The mean age at presentation for treatment is 24 years, with 10% of treatment visits taking place when patients are between the ages of 35 and 44 years.
Danish: Ved første fremmøde til behandling er patienterne i gennemsnit 24 år, men 10 % af behandlingsbesøgene finder sted, når patienterne er mellem 35 og 44 år.
English: On 28 June 2011 and 29 June 2011 Italy and Sweden respectively, triggered a referral under Article 6(12) of Commission Regulation EC No 1084/2003.
Danish: Den 28. juni 2011 og den 29. juni 2011 indbragte henholdsvis Italien og Sverige en sag i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003.
English: Overall summary of the scientific evaluation of Ethinylestradiol-Drospirenone 24+4 and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Ethinylestradiol-Drospirenone og relaterede navne (se bilag I)
English: The CHMP considered all the available data in view of the latter wording for the indication applied.
Danish: CHMP gennemgik alle foreliggende data med henblik på sidstnævnte ordlyd af den ansøgte indikation.
English: The specific content of the proposed educational program was to be agreed with the national competent authorities following the authorisation of the combined indication.
Danish: Det nærmere indhold af det påtænkte oplysningsprogram skulle aftales med de nationale kompetente myndigheder, efter at den kombinerede indikation var godkendt.
English: The social, psychological, and emotional impairment that can result from acne has been reported to be similar to that associated with epilepsy, asthma, diabetes, and arthritis.
Danish: De sociale, psykologiske og emotionelle følger af acne er beskrevet som svarende til dem, der er knyttet til epilepsi, astma, diabetes og artritis.
English: The prescription guide is expected to have a little impact on adherence to and compliance with the product information.
Danish: Ordinationsvejledning forventes kun at have ringe indflydelse på overholdelsen af produktinformationen.
English: The population included in the studies is considered representative of the respective target population for the treatment of moderate acne vulgaris.
Danish: Populationen i disse undersøgelser anses for at være repræsentativ for målpopulationen for behandling af moderat acne vulgaris.
English: Indeed, the prescriber will verify the need for a treatment for acne at the start of the prescribing period.
Danish: Den ordinerende læge vil således verificere behovet for acnebehandling ved begyndelsen af overordinationsperioden.
English: The MAH has not convincingly shown how this can be ensured during treatment.
Danish: Indehaveren af markedsføringstilladelsen har imidlertid ikke på overbevisende måde godtgjort, hvordan dette kan sikres også i løbet af behandlingen.
English: This treatment does not exempt patients from specific acne treatment if necessary.” in section 4.1 “Therapeutic Indications” of the Summary of Product Characteristics (SmPC).
Danish: Behandlingen bør ikke unddrage patienterne specifik acnebehandling, når denne er nødvendig” i afsnit 4.1 “Terapeutiske indikationer” i produktresuméet.
English: In addition, a higher percentage of subjects, 11.8% (18.6% versus 6.8%), showed a ‘clear' or ‘almost clear' rating on the Investigator's Static Global Assessment (ISGA) scale.
Danish: Desuden fik 11,8 % flere af forsøgsdeltagerne (18,6 % mod 6,8 %) bedømmelsen “opklaret” eller “næsten opklaret” på ISGA-skalaen (Investigator's Static Global Assessment).
English: Ethinylestradiol-Drospirenone 24+4 is a combined oral contraceptive (COC) and contains ethinylestradiol 20 µg and the progestogen drospirenone 3 mg (EE/DRSP).
Danish: Ethinylestradiol-Drospirenone er et kombineret oralt antikonceptivum, der indeholder ethinylestradiol 20 µg og gestagenet drospirenon 3 mg (EE/DRSP).
English: The MAH also committed to further improve and expand the educational program if the prescribing rate for the treatment of moderate acne in women not seeking contraception resulted higher than 10% in both drug utilization studies.
Danish: Desuden forpligtede indehaveren af markedsføringstilladelsen sig til at forbedre og udvide oplysningsprogrammet yderligere, såfremt andelen af ordinationer til behandling af moderat acne hos kvinder uden behov for antikonception skulle vise sig at overstige 10 % i begge undersøgelser af lægemiddelanvendelse.
English: The classification of acne severity is from mild, moderate, moderately severe to severe depending on the presence of the lesions.
Danish: Acne kan klassificeres som mild, moderat, middelsvær eller svær, afhængigt af tilstedeværelsen af læsioner.
English: The Marketing Authorisation Holder (MAH), Bayer B.V. submitted a type II variation via mutual recognition procedure for Ethinylestradiol-Drospirenone 24+4 and associated names (NL/H/1269, 1270/01/II/006) on 26 January 2009, to request an extension of the indication to include: “Oral contraception for women with moderate acne vulgaris.
Danish: Den 26. januar 2009 indgav indehaveren af markedsføringstilladelsen, Bayer B.V., en type IIændringsansøgning via den gensidige anerkendelsesprocedure for Ethinylestradiol-Drospirenone og relaterede navne (NL/H/1269, 1270/01/II/006) med henblik på udvidelse af indikationen med: “Oral svangerskabsforebyggelse hos kvinder med moderat acne vulgaris.
English: Namely, the educational program and the drug utilization studies proposed to monitor the effectiveness of the measures.
Danish: Disse foranstaltninger bestod dels i oplysningsprogrammet, dels de påtænkte undersøgelser af lægemiddelanvendelse til overvågning af foranstaltningernes effektivitet.
English: As mentioned above, these results are reflected in the pharmacodynamic data's section of the product information for EE/DRSP- COCs.
Danish: Som nævnt er disse resultater afspejlet i afsnittet om farmakodynamiske egenskaber i produktinformationen for kombinerede orale antikonceptiva med EE/DRSP.