FrancophonIA/ELRC3.0 huggingface dataset:
English: • For the condition of alopecia in view of the overall available safety data, in particular in relation to the risk of serious thromboembolic events, and very limited efficacy data, the PRAC concluded in accordance with Article 116 of Directive 2001/83/EC that the risk-benefit balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Croatian: • Za stanje alopecije s obzirom na sve dostupne podatke o sigurnosti, posebice u odnosu na rizik za ozbiljne tromboembolijske događaje, i na vrlo ograničene podatke o djelotvornosti, PRAC je zaključilo u skladu s člankom 116 Direktive 2001/83/EZ da omjer koristi i rizika nije povoljan pa ti lijekovi više ne smiju biti indicirani u toj terapijskoj indikaciji.
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Croatian: Pokazalo se da je rizik od venske tromboembolije za ženu najviši tijekom prve, početne godine uzimanja hormonskih kontraceptiva ili kada nakon razdoblja neuzimanja od najmanje mjesec dana, žena ponovno počne uzimati hormonske kontraceptive (Dinger et al,. 2007).
English: Hormone preparations containing CPA/EE were part of the comparator arms in these studies.
Croatian: U tim ispitivanjima hormonski preparati koji sadržavaju CPA/EE bili su dijelom usporedbenih skupina.
English: Post-marketing safety surveillance studies
Croatian: Ispitivanja radi nadzora sigurnosti nakon stavljanja lijeka u promet
English: The primary outcomes of interest are cardiovascular events, in particular the incidence of VTE and ATE, during oral contraception use.
Croatian: Primarni ishodi od interesa bili su kardiovaskularni događaji tijekom primjene peroralne kontracepcije, posebice venski i arterijski tromboembolijski događaji.
English: Furthermore the PRAC requested that a PASS will be conducted to evaluate the effectiveness of the risk minimisation activities.
Croatian: Nadalje, PRAC traži provedbu PASS-a radi procjene učinkovitosti aktivnosti za minimizaciju rizika.
English: In these studies VTE risk among CPA/EE users was compared to the VTE risk of non-use as well as of various types of combined oral contraceptives (COCs).
Croatian: U tim ispitivanjima uspoređivao se rizik od venske tromboembolije među korisnicama CPA/EE s takvim rizikom u žena koje nisu bile korisnice, a također i rizik od različitih vrsta kombiniranih peroralnih kontraceptiva (COC).
English: INAS-OC is a prospective, non-interventional, active surveillance study designed to assess the risk of short- and long-term use of YAZ (3 mg drospirenone/0.020mg ethinylestradiol), Yasmin (3 mg drospirenone/0.030mg ethinylestradiol) and of oral contraceptives and CPA/EE (2mg/0.035mg), conducted in 6 European countries and United States.
Croatian: INAS-OC je prospektivno, neintervencijsko, aktivno ispitivanje nadzora kojemu je namjena procijeniti rizik od kratkotrajne i dugotrajne upotrebe kontraceptiva YAZ (3 mg drospirenon/0,020 mg etinilestradiol), Yasmin (3 mg drospirenon/0,030 mg etinilestradiol) i peroralnih kontraceptiva te CPA/EE (2 mg/0,035 mg), a provedeno je u 6 europskih zemalja i Sjedinjenim Državama.
English: Two studies compared CPA/EE (2mg/0.035mg) with levonorgestrel/EE (LNG/EE).
Croatian: Dva ispitivanja usporedila su CPA/EE (2 mg/0,035 mg) s levonorgestrelom/EE (LNG/EE).
English: In study AI58, one patient on CPA/EE developed VTE.
Croatian: U ispitivanju AI58, jedna bolesnica koji je primala CPA/EE razvila je vensku tromboemboliju.
English: Acne without androgenic features
Croatian: Akne bez osobina djelovanja androgena
English: Concomitant medications
Croatian: Lijekovi koji se uzimaju istodobno
English: For the condition of alopecia in view of the very limited efficacy data, the PRAC concluded that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Croatian: Za stanje alopecije, s obzirom na vrlo ograničene podatke o djelotvornosti, PRAC je zaključio da omjer koristi i rizika nije povoljan i stoga ti lijekovi više ne bi smjeli biti indicirani u toj terapijskoj indikaciji.
English: For the treatment of acne, the medicinal products should only be used after topical therapy or systemic antibiotic treatments have failed.
Croatian: Za liječenje akni, lijekove treba uzimati samo nakon što su se topikalna terapija ili sistemsko liječenje antibioticima pokazali neuspješnima.
English: Thromboembolic events are known, rare adverse drug reactions associated with the use of estrogenprogestogen containing preparations including CPA/EE (2mg/0.035mg).
Croatian: Tromboembolijski događaji poznate su rijetke štetne reakcije na lijek povezane s upotrebom preparata koji sadrže estrogen-progestogen uključujući CPA/EE (2 mg/0,035 mg).
English: A total of 1094 users of CPA-containing preparations were enrolled in the study, representing 5.5% of the total study population based on 6th Interim Report of this on-going study.
Croatian: U ispitivanje je bilo uključeno ukupno 1094 žena koje su uzimale pripravke s CPA što je predstavljalo 5,5% ukupne ispitivane populacije prema 6. među-izvješću ovog ispitivanja u tijeku.
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
Croatian: • PRAC je razmotrio postupak prema članku 107i Direktive 2001/83/EZ za lijekove koji sadrže ciproteron acetat/ etinilestradiol (2 mg/0,035 mg).
English: In July 2002, the Pharmacovigilance Working Party (PhVWP) discussed the increased venous thromboembolic (VTE) and arterial thromboembolic (ATE) risks and concluded that the use of cyproterone acetate/ethinylestradiol (2mg/0.035mg) should be restricted taking into account the thromboembolic events.
Croatian: Radna skupina za farmakovigilanciju (PhVWP) raspravljala je o povećanim rizicima za vensku tromboemboliju (VTE) i arterijsku tromboemboliju (ATE) i zaključila da treba ograničiti upotrebu ciproteron acetata/etinilestradiola (2 mg/0,035 mg) uzimajući u obzir tromboembolijske događaje.
English: In INAS-OC study 28.1% of use is in contraception, from a total of 1672 users of CPA-containing preparations enrolled in the study, representing 7.5% of the total study population.
Croatian: U ispitivanju INAS-OC 28,1% primjene odnosi se na kontracepciju od ukupno 1672 korisnica preparata koji sadrže CPA uključenih u ispitivanje, što predstavlja 7,5% ukupne ispitivane populacije.
English: Pearl Index based on CPA/EE (2mg/0.035mg) clinical trial data (Study 8186, Aydinlik et al., 1990) Method failure
Croatian: Tablica 1 Pearlov indeks na temelju podataka kliničkog ispitivanja CPA/EE (2 mg/0,035 mg) (ispitivanje 8186, Aydinlik et al., 1990.)
English: Interruption and restarting is likely to be more frequent for CPA/EE (2mg/0.035mg) which is indicated for treatment of androgen-dependent diseases such as acne, and for which the product label implies that the medication may be discontinued after improvement of symptoms and be restarted in case of recurrence of symptoms.
Croatian: Prekidi uzimanja i ponovno započinjanje uzimanja čini se učestalije u primjeni CPA/EE (2 mg/0,035 mg) koje se indicira za liječenje bolesti ovisnih o androgenima kao što su akne, i za koja se u označavanju lijeka navodi da se upotreba lijeka može prekinuti nakon poboljšanja simptoma, a zatim ponovno nastaviti u slučaju ponovne pojave simptoma.
English: In addition the PRAC requested a study protocol to be provided within the risk management plan submission, for a drug utilisation study in order to better characterise prescribing practices for these medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Croatian: Osim toga, PRAC traži da se u okviru podnošenja plana upravljanja rizikom podnese protokol za ispitivanje iskoristivosti lijeka kako bi se bolje opisale prakse propisivanja tih lijekova u uobičajenoj kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek te radi procjene glavnih razloga propisivanja.
English: The IMS Prescriptions Insight Data for France (ANSM benefit/risk review, 5 Feb 2013) suggest that CPA/EE (2mg/0.035mg) containing medicines are prescribed for contraception.
Croatian: Podaci o receptima IMS Prescriptions Insight Data za Francusku (ANSM analiza koristi/rizika od 5. veljače 2013.) pokazuje da su lijekovi koji sadrže CPA/EE (2 mg/0,035 mg) propisivani za kontracepciju.
English: Overall, there is no conclusive evidence for a higher VTE risk with CPA/EE (2mg/0.035mg) compared to COCs, including those containing levonogestrel.
Croatian: Sveukupno, nema dokaza na temelju kojih se može zaključiti da je viši rizik od VTE uz primjenu CPA/EE (2 mg/0,035 mg) u usporedbi s kombiniranim peroralnim kontraceptivima, uključujući one koji sadrže levonogestrel.
English: In the INAS-SCORE study 20.2% of use is in contraception from a total of 1094 users of CPAcontaining preparations which represents 5.5% of the total study population.
Croatian: U ispitivanju INAS-SCORE 20,2% primjene odnosi se na kontracepciju od ukupno 1094 korisnica preparata koji sadrže CPA uključenih u ispitivanje, što predstavlja 5,5% ukupne ispitivane populacije.
English: There is only sparse data on arterial thrombotic and thromboembolic diseases with CPA/EE (2mg/0.035mg) or cyproterone acetate alone.
Croatian: Postoje samo malobrojni podaci o arterijskim trombotskim i tromboembolijskim bolestima uz primjenu CPA/EE (2 mg/0,035 mg) ili samog ciproteron acetata.
English: Off Label Use
Croatian: Upotreba izvan odobrenih indikacija
English: The estimate is based on the calculated patient exposure of 75,417,345 women-years and 52 reports of arterial embolic and thrombotic events worldwide.
Croatian: Procjena se temelji na izračunu izloženosti bolesnice od 75.417.345 žena-godina i 52 izvješća o arterijskim embolijskim i trombotskim događajima.
English: For the period since the global launch of CPA/EE (2mg/0.035mg) through 30 Jan 2013, 968 cases (serious (93%) and non-serious (7%), medically confirmed (85%) and non-medically confirmed (15%) reporting thrombotic/thromboembolic events irrespective of their nature (arterial, venous and unspecified) occurring in female patients were received by the MAH from worldwide sources.
Croatian: Za razdoblje od globalnog puštanja na tržište lijekova s CPA/EE (2 mg/0,035 mg) do 30. siječnja 2013., nositelj odobrenja primio je iz izvora diljem svijeta prijave za 968 slučaja (ozbiljnih (93%) i onih koji nisu ozbiljni (7%), medicinski potvrđenih (85%) i bez medicinske potvrde (15%) za trombotske/tromboembolijske događaje u bolesnica bez obzira na njihovu prirodu (arterijski, venski i neodređeno).
English: Several observational studies have assessed the VTE risk with use of CPA/EE (2mg/0.035mg).
Croatian: Nekoliko studija opažanja procjenjivalo je rizik od VTE uz primjenu CPA/EE (2 mg/0,035 mg).
English: In general, cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are authorised for treatment of androgenic symptoms in women, such as pronounced forms of acne, seborrhoea, and mild forms of hirsutism.
Croatian: Općenito, lijekovi koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) odobreni su za liječenje simptoma djelovanja androgena u žena, kao što su izraženi oblici akni, seboreje i blagi oblici hirzutizma.
English: These studies give some information regarding the use of CPA/EE (2mg/0.035mg) as a contraceptive.
Croatian: Ta ispitivanja daju neke informacije u odnosu na primjenu CPA/EE (2 mg/0,035 mg) kao kontraceptiva.
English: For the condition of alopecia in view of the overall available safety data, in particular in relation to the risk of serious thromboembolic events, and very limited efficacy data, the PRAC concluded that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Croatian: Za stanje alopecije, s obzirom na sve dostupne podatke o sigurnosti a posebice u odnosu na rizik od ozbiljnih tromboembolijskih događaja i vrlo ograničene podatke o djelotvornosti, PRAC zaključuje da omjer koristi i rizika nije povoljan pa ti lijekovi više ne bi smjeli biti indicirani u toj terapijskoj indikaciji.
English: In conclusion the PRAC considered all currently available safety data for the CPA/EE (2mg/0.035mg) containing medicinal products and recommended that these products should be contraindicated in patients with history or hereditary predisposition of venous thrombosis.
Croatian: U zaključku, PRAC je razmotrio sve danas dostupne sigurnosne podatke za lijekove koji sadrže CPA/EE (2 mg/0.035 mg) i preporučio da ti lijekovi budu kontraindicirani za bolesnice s nasljednom predispozicijom za vensku trombozu u anamnezi.
English: 892 (92.1%) of 968 cases reported non-fatal TE in association with CPA/EE (2mg/0.035mg) use, of which 760 were medically confirmed.
Croatian: U 892 (92,1%) od 968 slučajeva zabilježeni su tromboembolijski događaji bez smrtnog ishoda povezanih s upotrebom CPA/EE (2 mg/0,035 mg) , od kojih je 760 bilo medicinski potvrđeno.
English: Off-label use would primarily equate to prescription of CPA/EE (2mg/0.035mg) as a contraceptive in patients with no requirement for acne treatment.
Croatian: Primjena izvan odobrenih indikacija trebala bi prvenstveno odgovarati receptu za CPA/EE (2 mg/0,035 mg) kao kontraceptivu u bolesnica koje nemaju potrebe za liječenjem akni.
English: Only one study evaluated the efficacy of CPA/EE (2mg/0.035mg) versus placebo.
Croatian: Samo jedno ispitivanje procijenilo je djelotvornost CPA/EE (2 mg/0,035 mg) naspram placebu.
English: Fatal cases
Croatian: Slučajevi sa smrtnim ishodom
English: The combination of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) acts simultaneously as a hormonal contraceptive.
Croatian: Kombinacija ciproteron acetata/etinilestradiola (2 mg/0,035 mg) djeluje istodobno kao hormonski kontraceptiv.
English: The total number of patients exposed in these studies amounts to
Croatian: Ukupni broj bolesnika izloženih u tim ispitivanjima bio je 2455 bolesnika.
English: In January 2013 the French medicines agency (ANSM) took the decision to suspend cyproterone acetate/ethinylestradiol (CPA/EE) (2mg/0.035mg) containing medicinal products in France within three months.
Croatian: Francuska agencija za lijekove (ANSM) donijela je odluku u Francuskoj suspendirati lijekove koji sadrže ciproteron acetat/etinilestradiol (CPA/EE) (2 mg/0,035 mg) unutar tri mjeseca.
English: Healthcare professionals enrolled CPA/EE (2mg/0.035mg) users into the studies due to the fact that in many European countries CPA/EE (2mg/0.035mg) mentions contraception in women requiring treatment for androgen dependent skin conditions.
Croatian: Zdravstveni djelatnici uključili su korisnice ciproteron acetata/etinilestradiola (2 mg/0,035 mg) u ispitivanja zbog činjenice da se u mnogim europskim zemljama ciproteron acetat/etinilestradiol (2 mg/0,035 mg) spominje za kontracepciju u žena kojima je potrebna terapija za stanja kože ovisna o androgenima.
English: A total of 52 (5.4%) of 968 retrieved cases reported one or more ATEs in association with CPA/EE (2mg/0.035mg) use.
Croatian: Ukupno 52 (5,4%) od 968 dohvaćenih slučajeva zabilježilo je jednu ili više nuspojava povezanih s upotrebom CPA/EE (2 mg/0,035 mg)
English: In view of the above, on 4 February 2013 France requested the PRAC under Article 107i of Directive 2001/83/EC1 to assess the above concerns regarding thromboembolism and its impact on the benefitrisk balance for cyproterone acetate/ethinylestradiol (2 mg/0.035 mg) containing medicinal products, and to give its opinion on measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Croatian: Francuska je zatražila da PRAC prema članku 107i Direktive 2001/83/EZ1 procijeni gornje razloge za zabrinutost s obzirom na tromboemboliju i njene utjecaje na omjer koristi i rizika za lijekove koji sadrže ciproteron acetat /etinilestradiol (2 mg/0,035 mg) i da iznese svoje mišljenje o mjerama potrebnim kako bi se zajamčila sigurna i djelotvorna upotreba tih lijekova te treba li ostaviti, promijeniti, suspendirati ili povući odobrenja za stavljanje lijeka u promet.
English: The estimate is based on the calculated global patient exposure of 75,417,345 women-years and 968 received TE reports worldwide.
Croatian: Procjena se temelji na izračunatoj globalnoj izloženosti bolesnica od 75.417.345 žena-godina i 968 primljenih izvješća o tromboembolijskim događajima diljem svijeta.
English: The estimate is based on the calculated patient exposure of 75,417,345 women-years and 789 reports of venous embolic and thrombotic events worldwide.
Croatian: Procjena se temelji na izračunu izloženosti bolesnice od 75.417 345 žena-godina i 789 izvješća o venskim embolijskim i trombotskim događajima.
English: • The PRAC also considered that in view of the currently available safety data in order to maintain a favourable benefit/risk for the indications referred above cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products should be contraindicated in patients with history or hereditary predisposition of venous thrombosis.
Croatian: • PRAC također smatra da s obzirom na danas dostupne sigurnosne podatke, da bi se održao povoljni omjer koristi i rizika za prethodno navedene indikacije, lijekovi koji sadrže ciproteron acetat/etinilestradiol (2 mg/0,035 mg) trebaju biti kontraindicirani za bolesnice s nasljednom predispozicijom za vensku trombozu u anamnezi.
English: Data from these two studies indicate that, even where the primary reason for consultation is almost certainly contraception, 63% of prescriptions for CPA/EE (2mg/0.035mg) could be linked by the patients themselves to acne and/or other hyper-androgenous conditions.
Croatian: Podaci iz ta dva ispitivanja pokazuju da, čak i kada je primarni razlog savjetovanja gotovo sigurno kontracepcija, 63% recepata za CPA/EE (2 mg/0,035 mg) same bolesnice/pacijentice mogu povezati s aknama i/ili drugim hiperandrogenim stanjima.
English: The study (currently ongoing) seeks to assess the risks of short- and longterm use of Qlaira (dienogest/estradiol valerate, step down dose regimen) and of oral contraceptives and including CPA/EE (2mg/0.035mg).
Croatian: Ispitivanjem (koje još traje) nastoje se procijeniti rizici kratkotrajne i dugotrajne primjene tableta Qlaira (dienogest/estradiol valerat u režimu prema nižim dozama) i peroralnih kontraceptiva uključujući CPA/EE (2 mg/0,035 mg).
English: Palombo-Kinne E, et al., 2009) comparing CPA/EE (2mg/0.035mg) with dienogest containing combined oral contraceptive and with norgestimate containing combined oral contraceptive also showed similar efficacy.
Croatian: Dva ispitivanja (A18566, 2004., Palombo-Kinne E, et al., 2009.) u kojima se uspoređivala primjena CPA/EE (2 mg/0,035 mg) s peroralnim kontraceptivima koji sadrže dienogest te kombinirane peroralne kontraceptive koji sadrže norgestimat također su pokazala sličnu djelotvornost.
English: • The PRAC confirmed the known risk of thromboembolism of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.
Croatian: • PRAC je potvrdio poznati rizik za tromboemboliju povezan s lijekovima koji sadrže ciproteron acetat/eilinestradiol (2 mg/0,035 mg), i preporučio jasno navođenje simptoma tromboembolijksih događaja kao i čimbenika rizika za tromboembolijske događaje.
English: These studies investigate the safety of the combined oral contraceptives YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Croatian: Ta ispitivanja istražuju sigurnost kombiniranih peroralnih kontraceptiva YAZ (3 mg drospirenon/0,020 mg etinilestradiol) i Qlaira (dienogest/estradiol valerat, režim prema nižim dozama).
English: The CMDh having considered the PRAC recommendation dated 16 May 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC reached a position on the variation to the terms of the marketing authorisations of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Croatian: Nakon razmatranja preporuke PRAC-a od 16. svibnja 2013. u skladu s člankom 107k(1) i (2) Direktive 2001/83/EZ CMDh donosi mišljenje o varijaciji uvjeta davanja odobrenja za lijekove koji sadrže ciproteron acetat/ etinilestradiol (2 mg/0,035 mg) za koje su relevantni dijelovi Sažetka opisa svojstava lijeka i Informacija za korisnika navedeni u Dodatku III i podliježu uvjetima navedenim u Dodatku IV.
English: A total of 1672 users of CPA/EE (2mg/0.035mg) -containing preparations were enrolled in the study representing 7.5% of the total study population.
Croatian: U ispitivanje je bilo uključeno ukupno 1672 žena koje su uzimale pripravke s CPA/EE (2 mg/0,035 mg) što je predstavljalo 7,5% ukupne ispitivane populacije.
English: The fact that the women recalled the link with acne / PCOS indicates that the need for treatment of the skin condition / hyperandrogenism of the individual woman was specifically discussed during the visit and drove the prescription of CPA/EE (2mg/0.035mg).
Croatian: Činjenica da su žene zapamtile povezanost s aknama / sindromom policističnih jajnika pokazuje da se u razgovoru prilikom dolaska liječniku posebice govorilo o potrebi liječenja stanja kože / hiperandrogenimiji pojedine žene i da je to dovelo do propisivanja CPA/EE (2 mg/0,035 mg).
English: A drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers was also considered.
Croatian: Razmatralo se također ispitivanje iskoristivosti lijeka kako bi se opisale prakse propisivanja lijekova u uobičajenoj kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek.
English: In this study almost 67% of women prescribed CPA-containing preparations remembered after the discussion with their healthcare professional that their individual prescription was written for acne and/or PCOS, indicating that the skin condition was discussed during the counselling and was mentioned as the main reason to prescribe CPA/EE (2mg/0.035mg).
Croatian: U ovom ispitivanju gotovo 67% žena kojima su propisani pripravci s CPA zapamtilo je nakon razgovora sa svojim liječnikom da su im recepti propisani zbog akni i/ili sindroma policističnih jajnika, što pokazuje da se tijekom savjetovanja govorilo o stanju kože i bilo je spomenuto kao glavni razlog propisivanja CPA/EE (2 mg/0,035 mg).
English: A total of 175 cases (all serious, medically confirmed (38.3%, n=67 in total) and non-medically confirmed (61.7%, n=108 in total)) reporting thrombotic / thromboembolic events (TE) irrespective of their nature (arterial, venous and unspecified) occurring in female patients in association with CPA/EE (2mg/0.035mg) were received by the MAH from worldwide sources additionally to the 968 TE cases presented in the main analysis.
Croatian: Nositelj odobrenja primio je iz različitih izvora diljem svijeta prijave za ukupno 175 slučajeva, svi ozbiljni, medicinski potvrđeni (38,3%, n=67 ukupno) i za one koji nisu bili medicinski potvrđeni (61,7%, n=108 ukupno)) trombotskih / tromboembolijskih događaja bez obzira na njihovu prirodu (arterijski, venski i neodređeno) zabilježenih u bolesnica povezano s CPA/EE (2 mg/0,035 mg) uz 968 tromboembolijskih slučajeva opisanih u glavnoj analizi.
English: The PRAC considered all the above data for the CPA/EE (2mg/0.035mg) containing medicinal products and recommended clarification on the indication of the products.
Croatian: PRAC je razmotrio sve prethodno navedene podatke za lijekove koji sadrže CPA/EE (2 mg/0,035 mg) i preporučilo pojašnjenje indikacija za te lijekove.