FrancophonIA/ELRC3.0 huggingface dataset:
English: Flexible phase (Day 25 to Day 120)
Danish: Fleksibel fase (dag 25 til dag 120)
English: Although the final results will only be available in 2013, this PI is considered conclusive in terms of precision.
Danish: De endelige resultater vil først være tilgængelige i 2013, men denne PI-værdi anses for konklusiv hvad nøjagtighed angår.
English: In summary, usability of the dispenser is considered acceptable, and confirmed by the interim data of the additional dispenser study.
Danish: Sammenfattende anses brugbarheden af dispenseren for at være acceptabel og bekræftet af interimdata fra den supplerende undersøgelse med dispenser.
English: She schedules no withdrawal bleeding, thus no tablet-free interval.
Danish: Hun planlægger ingen bortfaldsblødning og således intet tabletfrit interval.
English: In this study, two versions of the dispenser - with or without acoustic alarm - are compared.
Danish: I denne undersøgelse sammenlignedes to versioner af dispenseren - med og uden akustisk alarm.
English: However only raw data on bleeding patterns were submitted and no analyses in this regard are available.
Danish: Der blev imidlertid kun forelagt rå data om blødningsmønstre, og der foreligger ingen analyser heraf.
English: • The Committee reviewed all available data submitted by the applicant to address the potential serious risk to public health, in particular concerning the contraceptive efficacy of the proposed extended dosing regimen.
Danish: • udvalget gennemgik alle data, der er forelagt af ansøgeren vedrørende den potentielle alvorlige risiko for den offentlige sundhed, navnlig den antikonceptive virkning af det ansøgte udvidede do seringsregime
English: Both were presented as pivotal studies with regard to the efficacy and safety assessment of Yvidually.
Danish: Begge undersøgelser blev forelagt som hovedundersøgelser til vurdering af virkningen og sikkerheden af Yvidually.
English: Yvidually is intended to be marketed with an innovative tablet dispenser with a reminder function.
Danish: Yvidually påtænkes markedsført med en innovativ tabletdispenser med påmindelsesfunktion.
English: Each film-coated tablet of Yvidually contains 3 mg of drospirenone (DRSP) + 20 micrograms of ethinylestradiol (EE).
Danish: Hver filmovertrukken tablet af Yvidually indeholder 3 mg drospirenon (DRSP) + 20 µg ethinylestradiol (EE).
English: During the CMDh referral, since no agreement was reached, the procedure was referred to the CHMP according to Article 29(4).
Danish: Da der ikke opnåedes enighed ved CMDh-indbringelsen, blev proceduren henvist til CHMP i overensstemmelse med artikel 29, stk. 4.
English: Clinical studies The 2 phase III studies were conducted from 2005 to 2009 (study A40196 in Europe and Canada and study A48294 in the US).
Danish: Kliniske undersøgelser De to fase III-undersøgelser blev udført fra 2005 til 2009 (undersøgelse A40196 i Europa og Canada og undersøgelse A48294 i USA).
English: The current application concerns Yvidually and associated names for the indication of oral contraception.
Danish: Den behandlede ansøgning vedrører Yvidually og tilknyttede navne med indikationen oral antikonception.
English: This application was submitted according to Article 8(3) of Directive 2001/83/EC - full application, and assessed according to the decentralised procedure, with the NL acting as RMS (NL/H/2041/001/DC).
Danish: Denne ansøgning blev indgivet i henhold til artikel 8, stk. 3, i direktiv 2001/83/EF - fuldstændig ansøgning - og blev vurderet i overensstemmelse med den decentrale procedure med Nederlandene som referencemedlemsstat (NL/H/2041/001/DC).
English: Most women rate the dispenser as easy to use and have no difficulties in understanding the Quick reference card, User manual, and Symbol Guide.
Danish: Størstedelen af kvinderne bedømmer dispenseren til at være let at bruge og har ikke vanskeligt ved at forstå den kortfattede vejledning, brugsanvisningen eller symboloversigten.
English: But women had also the option to follow the bleeding rules of the YAZ FlexMB.
Danish: Kvinden kunne dog også vælge at følge blødningsreglerne for YAZ FlexMB.
English: Within this period, the woman may decide herself to take a 4-day tablet-free interval or not.
Danish: I denne periode kan kvinden vælge at tage et 4-dages tabletfrit interval eller at lade være.
English: The longer the postponement the higher this risk, which is clearly shown in the fixed extended arm in which no break - no withdrawal bleed was allowed (33 days of intracyclic bleeding/year).
Danish: Jo længere udsættelse, desto højere risiko, hvilket klart ses af fixed extended-armen, hvor der ikke blev tilladt nogen pause - bortfaldsblødning blev ikke tilladt (33 dage med intracyklisk blødning pr. år).
English: • YAZ Stop & Go regimen
Danish: • YAZ Stop & Go-regime
English: Bleeding pattern of the dosing regimen
Danish: Blødningsmønsteret for doseringsregimet
English: Contraceptive efficacy of the dosing regimen
Danish: Den antikonceptive virkning af doseringsregimet
English: General dosing rules:
Danish: Generelle regler for doseringen:
English: Thus, the CHMP only considered the EU-Canada study, which is the study that included women in Europe (n=880) as pivotal for the assessment of the contraceptive efficacy of Yvidually.
Danish: CHMP tog derfor kun EU-/Canada-undersøgelsen, dvs. den undersøgelse, der inkluderede kvinder i Europa (n=880), i betragtning som hovedundersøgelse for vurderingen af den antikonceptive virkning af Yvidually.
English: Therefore the data available do not indicate that the noted bleeding patterns had a negative impact on tolerability of the women choosing a flexible dose regimen in order to postpone withdrawal bleeding.
Danish: De foreliggende data tyder derfor ikke på, at de iagttagne blødningsmønstre havde negativ indvirkning på tolerabiliteten hos kvinder, der valgte et fleksibelt doseringsregime for at udskyde bortfaldsblødning.
English: However, the noted slight increase in days of intracyclic bleeding or other bleeding problems were not shown to result in a high number of discontinuations: 8/888 (0.8%) in the EU/CAN study and 12/1406 (0.9%) in the US study.
Danish: Den konstaterede lille stigning i antal dage med intracyklisk blødning eller andre blødningsproblemer resulterede imidlertid ikke i et øget antal seponeringer: 8/888 (0,8 %) i EU-/CAN-undersøgelsen og 12/1 406 (0,9 %) i USA-undersøgelsen.
English: The contraceptive efficacy was investigated in the YAZ Flex MB regimen arm in both pivotal studies.
Danish: Den antikonceptive virkning blev undersøgt i YAZ Flex MB regime-armen i begge hovedundersøgelser.
English: There are no signals that the compliance is less than that reported in the initial clinical studies, in which a paper + pencil was used to adhere to the dose regimen.
Danish: Der er ingen tegn på, at kompliansen er ringere end i de første kliniske undersøgelser, hvor der blev brugt papir og blyant til at sikre overholdelse af dosisregimet.
English: In the additional European study 14701, the bleeding pattern of the regimen applied for including use of the tablet dispenser was investigated.
Danish: I den supplerende europæiske undersøgelse 14701 undersøgtes blødningsmønsteret ved det ansøgte regime, herunder anvendelse af tabletdispenseren.
English: In this study, Pearl Indices obtained were in line with those obtained in the original file of YAZ 24+4.
Danish: I denne undersøgelse svarede de målte værdier af Pearl-indeks til dem, der blev bestemt i den originale dokumentation for YAZ 24+4.
English: US study A48294
Danish: USAundersøgelse A48294
English: EU/Canada study A40196
Danish: EU-/Canadaundersøgelse A40196
English: In addition, the number of patients in this YAZ Stop & Go arm is much lower compared to the Flex MB regimen (200 vs. 1400 patients) hampering any comparison.
Danish: Desuden er patientantallet i denne YAZ Stop & Go-arm meget lavere end i Flex MB-regimet (200 mod 1 400 patienter), hvilket vanskeliggør sammenligning.
English: The CHMP requested the applicant to submit the final results of the study 14701 when available, to show that the use of the dispenser positively influences the compliance of Yvidually.
Danish: CHMP anmodede ansøgeren om at forelægge de endelige resultater af undersøgelse 14701, når de foreligger, for at bekræfte, at anvendelsen af dispenseren har positiv indflydelse på kompliansen for Yvidually.
English: The applicant should submit to the National Competent Authorities the final results of the study 14701by 28 February 2013.
Danish: Ansøgeren forelægger de endelige resultater af undersøgelse 14701 for de nationale kompetente myndigheder senest den 28. februar 2013.
English: As expected with an extended dosage regimen, different bleeding patterns have been observed, but the data available do not indicate that the noted bleeding patterns of Yvidually had a negative impact on tolerability of the women.
Danish: Som forventeligt med et udvidet doseringsregime er der iagttaget forskellige blødningsmønstre, men de foreliggende oplysninger tyder ikke på, at de konstaterede blødningsmønstre for Yvidually havde negativ indvirkning på tolerabiliteten hos kvinderne.
English: Table 1 Overview of the different regimens studied in the pivotal trials US study A48294 (3 arms)
Danish: Tabel 1 Oversigt over de forskellige regimer omfattet af hovedundersøgelserne USA-undersøgelse A48294 (3 arme)
English: Interim analysis of the additional study 14701 with Yvidually and the tablet dispenser indicates that women rate the dispenser as easy to use, and that there are no signals that it adversely affects compliance.
Danish: Interimanalyser at den supplerende undersøgelse 14701 med Yvidually og tabletdispenseren viser, at kvinderne bedømmer dispenseren til at være let at bruge, og at intet tyder på, at den har negativ indflydelse på kompliansen.
English: When starting intake of Yvidually, tablets must be taken continuously for a minimum of 24 days
Danish: Når indtag af Yvidually påbegyndes, skal tabletterne tages uafbrudt i mindst 24 dage.
English: Table 2 Pearl index in the treatment arms YAZ Stop & Go, YAZ fixed extended and YAZ
Danish: Tabel 2 Pearl-indeks i behandlingsarmene YAZ Stop & Go, YAZ fixed extended og YAZ 24+4
English: This high PI outcome is unreliable and not in line with CHMP Guideline on Clinical Investigation of Steroid Contraceptives in Women (EMEA/CPMP/EWP/519/98 Rev 1), which requires that a sufficient number of cycles should be studied to obtain the desired precision of the estimate of contraceptive efficacy.
Danish: Denne høje PI-værdi er upålidelig og følger ikke CHMP's “Guideline on Clinical Investigation of Steroid Contraceptives in Women” (EMEA/CPMP/EWP/519/98 Rev 1), som kræver, at der undersøges et tilstrækkeligt antal cyklusser for at opnå den ønskede præcision af estimatet for den antikonceptive virkning.
English: The applicant has also provided interim results of the additional study 14701 with Yvidually and the tablet dispenser.
Danish: Ansøgeren har desuden forelagt interimresultater at den supplerende undersøgelse 14701 med Yvidually og tabletdispenseren.
English: EU/CAN study A40196 (3 arms)
Danish: EU-/CAN-undersøgelse A40196 (3 arme)
English: Only usability testing required by the Medical Device Directive 93/42 has been performed, which is considered to be acceptable since a medical device that is intended to administer a medicinal product is governed by the Directive 93/42, without prejudice to the provisions of Directive 2001/83 with regard to the medicinal product.
Danish: Dette anses for acceptabelt, da en medicinsk anordning til administration af et lægemiddel er underlagt direktiv 93/42, medmindre andet er fastsat i direktiv 2001/83 for det pågældende lægemiddel.
English: Based on the above, the CHMP agreed that the results of the YAZ Flex MB regimen could be extrapolated to a regimen where women are allowed to schedule their withdrawal bleeding irrespective of bleeding and/or spotting.
Danish: På ovenstående grundlag bestemte CHMP, at resultaterne for YAZ Flex MB-regimet kan ekstrapoleres til et regime, hvor kvinderne gives mulighed for at planlægge deres bortfaldsblødning uafhængigt af blødning og/eller pletblødning.
English: The composition of Yvidually is identical to the authorised combined oral contraceptive (COC) Yaz 24+4.
Danish: Sammensætningen af Yvidually er den samme som af det godkendte orale antikonceptionsmiddel af kombinationstypen Yaz 24+4.
English: During days 25-120, the tablets can be taken continuously up to a maximum of 120 days.
Danish: På dag 25-120 kan tabletterne tages uafbrudt i op til højst 120 dage.
English: With the regimen applied for, a tablet-free interval is allowed at any time during day 25 to 120 of the treatment cycle - i.e. any 4-day break can only be started if tablet taking has been continuous for 24 days.
Danish: Med det ansøgte regime kan der vælges et tabletfrit interval på ethvert tidspunkt fra dag 25 til 120 i behandlingscyklussen, dvs. en 4-dages pause kun kan påbegyndes, når tabletterne har været taget uden afbrydelse i 24 dage.
English: Tablet dispenser
Danish: Tabletdispenser
English: • YAZ Flex MB regimen
Danish: YAZ Flex MB
English: As the difference between the point estimate and the upper limit of the 95% CI is smaller than 1, it can be concluded that this EU-Canada study on its own is sufficiently large with regard to requirements on precision of the point estimate as recommended in the CHMP Guideline on Clinical Investigation of Steroid Contraceptives in Women (EMEA/CPMP/EWP/519/98 (Rev 1), and therefore considered reliable.
Danish: Da forskellen mellem punktestimatet og øvre 95 % sikkerhedsgrænse er mindre end 1, kan det konkluderes, at denne EU-/Canada-undersøgelse i sig selv er tilstrækkelig stor i henhold til anbefalingerne for præcisionen af punktestimatet i CHMP's “Guideline on Clinical Investigation of Steroid Contraceptives in Women” (EMEA/CPMP/EWP/519/98 (Rev 1)) og derfor anses for pålidelig.
English: If 3 consecutive days of bleeding and/or spotting occurred during a treatment cycle, a 4-day tablet-free period was advised (i.e. ‘managed bleeding' = MB).
Danish: Hvis der i løbet af en behandlingscyklus forekom 3 på hinanden følgende dage med blødning og/eller pletblødning, blev deltagerne tilrådet en 4-dages tabletfri periode (dvs. kontrolleret blødning (“managed bleeding” = MB).
English: After each 4-day tablet-free interval, a new mandatory intake cycle of a minimum of 24 days starts.
Danish: Efter hvert 4-dages tabletfrit interval begynder en ny cyklus med obligatorisk indtag i mindst 24 dage.
English: The mean duration of withdrawal bleeding was longer in the extended cycle regimens and the mean duration of the intracyclic bleeding episodes was higher when compared to YAZ 24+4 (7-8 days vs 5 days).
Danish: Gennemsnitsvarigheden af bortfaldsblødning var længere i regimerne med forlænget cyklus, og gennemsnitsvarigheden af de intracykliske blødningsepisoder var længere end med YAZ 24+4 (7-8 dage mod 5 dage).
English: • After any 4-day tablet-free interval , a new mandatory phase starts, i.e. tablets must be taken for a minimum of 24 days before any new break can be scheduled.
Danish: • Efter hvert 4-dages tabletfrit interval begynder en ny obligatorisk fase, dvs. tabletterne skal tages i mindst 24 dage, før der kan planlægges en ny pause.
English: • Any 4-day tablet free interval can only be started if tablet taking has been continuous for 24 days i.e. after the completion of the mandatory phase.
Danish: • Et eventuelt 4-dages tabletfrit interval må kun påbegyndes, efter at tabletterne har været taget uafbrudt i 24 dage, dvs. efter fuldførelse af den obligatoriske fase.
English: Based on the above, the CHMP agreed that the results of the YAZ Flex MB regimen could be extrapolated to the proposed dosing regimen of Yvidually.
Danish: På ovennævnte grundlag godtog CHMP, at resultaterne for YAZ Flex MB-regimet ekstrapoleres til det ansøgte dosisregime for Yvidually.
English: YAZ flex MB in 880 women for 2 years (contraceptive efficacy + bleeding)
Danish: YAZ Flex MB hos 880 kvinder i 2 år (antikonceptiv virkning + blødning)
English: Irrespective of bleeding and/or spotting, women are allowed to schedule their withdrawal bleeding (i.e. the 4-day tablet-free interval) at any time between days 25 and 120 of the treatment cycle.
Danish: Uanset blødning og/eller pletblødning kunne kvinden vælge at planlægge bortfaldsblødningen (dvs. det 4-dages tabletfri interval) til et vilkårligt tidspunkt mellem dag 25 og 120 i behandlingscyklussen.
English: These studies evaluated contraceptive efficacy, i.e. the number of unintended pregnancies, PI (calculated as the pregnancy rate in population divided by 100 years of user exposure) and cumulative pregnancy rate in the YAZ Flex MB arms, as well as bleeding pattern and cycle control parameters in all treatment arms of both studies.
Danish: I disse undersøgelser vurderedes den antikonceptive virkning, dvs. antallet af utilsigtede graviditeter, Pearl-indeks (PI) (beregnet som graviditetsrate i populationen divideret med 100 års brugereksponering) og den kumulative graviditetsrate i undersøgelsernes YAZ Flex MB-arme samt blødningsmønster og cykluskontrolparametre i alle behandlingsarme i begge undersøgelser.
English: Notwithstanding, during the initial DCP procedure a calculation of the PI was requested for the Stop & Go arm, YAZ fixed extended arm, and YAZ 24+4 arm, see table below:
Danish: Under den indledende decentrale procedure blev der alligevel anmodet om en beregning af Pearl-indeks for Stop & Go-armen, YAZ fixed extended-armen og YAZ 24+4-armen, jf. nedenstående tabel:
English: During days 25- 120, the woman may decide to take a 4-day tablet-free interval (she schedules a withdrawal bleeding) at any time that suits her best, and irrespective of bleeding.
Danish: På dag 25-120 kan kvinden vælge at tage et 4-dages tabletfrit interval (hun planlægger en bortfaldsblødning) på ethvert tidspunkt, der passer hende, og uafhængigt af blødning.
English: Additionally, as presented by the applicant, only slight differences in the number of cycles (i.e 4-day breaks) and mean cycle length (number of days of continuous intake of tablets) between YAZ Flex MB variant and the YAZ Stop & Go regimen were observed (see tables below).
Danish: Dertil kommer, at der ifølge ansøgerens redegørelse kun blev iagttaget små forskelle i antallet af cyklusser (dvs. 4-dages pauser) og gennemsnitlig cykluslængde (antal dage med uafbrudt tabletindtag) mellem YAZ Flex MB-varianten og YAZ Stop & Go-regimet (se tabellerne nedenfor).
English: However it was discussed and noted that the high PI in YAZ Stop & Go arm of USstudy A48294 was based on only 170 Woman Years (WY) of use, resulting in a wide 95% CI; 3.52 (95% CIs: 1.29 - 7.67).
Danish: Det blev imidlertid drøftet og bemærket, at det høje PI i YAZ Stop & Go-armen af USA-undersøgelsen A48294 var baseret på kun 170 kvindeårs (WY) anvendelse, hvilket medførte et bredt 95 % sikkerhedsinterval: 3,52 (95 % SI: [1,29; 7,67]).
English: Further evidence for the efficacy of the YAZ Stop & Go regimen was obtained when the results of an interim analysis of an additional ongoing European multi-center randomised open study 14701, using the dispenser with the proposed dosing regimen of Yvidually became available.
Danish: Virkningen af YAZ Stop & Go-regimet blev yderligere dokumenteret ved en interimanalyse af den supplerende igangværende europæiske, randomiserede, åbne multicenterundersøgelse 14701, hvor dispenseren anvendes med det ansøgte doseringsregime for Yvidually.
English: Pearl Index 95% CI 1.29 - 7.67 0.00 - 3.47 0.13 - 3.85 0.15 - 4.35
Danish: Pearlindeks 95 % SI 1,29-7,67
English: During days 25- 120, she may schedule a 4-day tablet-free interval (induction of withdrawal bleeding) in the event of 3 consecutive days of bleeding.
Danish: PÅ dag 25-120 kan hun planlægge et 4-dages tabletfrit interval (fremkaldelse af bortfaldsblødning), hvis der forekommer 3 på hinanden følgende dage med blødning.
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC.
Danish: 29, stk. 4, i Rådets direktiv 2001/83/EF
English: The extended dose regimen of Yvidually has been developed based on the marketed combined oral contraceptive Yaz 24+4 for women who want to postpone the withdrawal bleeding by extending the intake cycle up to 120 days.
Danish: Det udvidede dosisregime for Yvidually er udviklet på grundlag af det markedsførte kombinerede orale antikonceptionspræparat Yaz 24+4 til kvinder, der ønsker at udsætte bortfaldsblødningen ved at forlænge cyklus i indtil 120 dage.
English: YAZ Stop & Go in 200 women for 1 year (bleeding) YAZ 24+4 in 200 women for 1 year (bleeding)
Danish: Yaz Stop & Go hos 200 kvinder i 1 år (blødning) Yaz 24+4 hos 200 kvinder i 1 år (blødning)
English: YAZ fixed extended in 200 women for 1 year (bleeding) YAZ 24+4 in 200 women for 1 year (bleeding)
Danish: Yaz fixed extended hos 200 kvinder i 1 år (blødning) Yaz 24+4 hos 200 kvinder i 1 år (blødning)
English: The exposure was limited to 357 women-years (wy), but the calculated PI was 0, with an upper limit of the 95% confidence interval of 1.0 fulfilling the requirements of precision of the CHMP Guideline on Clinical Investigation of Steroid Contraceptives in Women (EMEA/CPMP/EWP/519/98 Rev 1).
Danish: Eksponeringen var her kun 357 kvindeår (wy), men det beregnede PI var 0 med en øvre 95 % sikkerhedsgrænse på 1,0 og opfylder således kravene til nøjagtighed i CHMP's “Guideline on Clinical Investigation of Steroid Contraceptives in Women” (EMEA/CPMP/EWP/519/98 Rev 1).
English: Based on the above, it was concluded that contraceptive efficacy had been sufficiently demonstrated with the YAZ Flex MB variant of the regimen (Pearl Index of 0.63, upper limit of 95% CI 1.24), which is considered representative of the proposed dosing regimen of Yvidually with regard to contraceptive efficacy.
Danish: På ovennævnte grundlag konkluderedes det, at den antikonceptive virkning er tilstrækkeligt godtgjort med YAZ Flex MB-varianten af regimet (Pearl-indeks 0,63, 95 % øvre sikkerhedsgrænse 1,24), som anses for repræsentativ for det ansøgte doseringsregime for Yvidually hvad angår antikonceptiv virkning.
English: • The Committee considered that the overall efficacy has been sufficiently proven by the data presented, in particular the EU/Canada study.
Danish: • udvalget fandt den overordnede virkning tilfredsstillende godtgjort med de forelagte undersøgelser,
English: Additionally, a third study (A47505) was conducted in women with moderate to severe primary dysmenorrhea and is presented as a supportive clinical trial regarding information on bleeding pattern during use of the extended dose regimen.
Danish: Desuden blev der udført en tredje undersøgelse (A47505) hos kvinder med moderat til svær primær dysmenorré.
English: In summary, the data have demonstrated that compared to YAZ 24+4, the number of withdrawal episodes decreases as well as the total number of bleeding days over a period of 1 year, which is the aim of this product.
Danish: Sammenfattende viser oplysningerne, at produktet i forhold til YAZ 24+4 giver færre bortfaldsepisoder og samlet færre blødningsdage på 1 år, hvilket er hensigten.
English: Evidence is primarily based on the adequate pearl indices obtained on EU/Canada study including an European population that allowed a 4-day tablet-free interval in case of 3 consecutive days of bleeding and/or spotting (Flex MB regimen).
Danish: Dokumentationen bygger primært på de tilfredsstillende værdier af Pearl-indekset, der blev opnået i EU-/Canada-undersøgelsen, som omfattede en europæisk population og tillod et 4-dages tabletfrit interval i tilfælde af 3 på hinanden følgende dage med blødning og/eller pletblødning (Flex MB-regime).