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Vijesti Objavljeno 23.04.2015. Pilula za dan poslije u ljekarnama i bez recepta Slijedom odluke Europske komisije (EK) o promjeni načina izdavanja lijeka ellaOne, Agencija za lijekove i medicinske proizvode - HALMED izdala je priopćenje o početku izdavanja lijeka ellaOne 30 mg tableta (ulipristalacetat) bez liječničkog... Slijedom odluke Europske komisije (EK) o promjeni načina izdavanja lijeka ellaOne , Agencija za lijekove i medicinske proizvode – HALMED izdala je priopćenje o početku izdavanja lijeka ellaOne 30 mg tableta (ulipristalacetat) bez liječničkog recepta. Navedena odluka EK o bezreceptnom načinu izdavanja lijeka ellaOne pravno je obvezujuća za zemlje članice Europske unije, uključujući i Hrvatsku, a donesena je na temelju preporuke Europske agencije za lijekove (EMA) o kojoj je HALMED izvijestio dana 21. studenoga 2014. godine.
“Nositelj odobrenja za stavljanje lijeka ellaOne u promet u EU, tvrtka Laboratoire HRA Pharma, pripremio je i izradio pakiranja lijeka, sažetak opisa svojstava i uputu o lijeku na hrvatskom jeziku prilagođene bezreceptnom izdavanju. Time je nositelj odobrenja ispunio obveze koje je EK postavila kao preduvjet za početak izdavanja lijeka ellaOne bez liječničkog recepta.
Budući da su uvjeti za provedbu odluke EK u RH ostvareni, predstavnik nositelja odobrenja u RH, tvrtka Arenda d.o.o., obavijestio je HALMED da će pakiranja lijeka ellaOne prilagođena bezreceptnom izdavanju biti dostupna u ljekarnama u RH od dana 22. travnja 2015. godine. Preostala pakiranja lijeka namijenjena izdavanju uz liječnički recept, koja se još uvijek nalaze u pojedinim ljekarnama u RH, nastavit će se izdavati do isteka zaliha isključivo uz liječnički recept”, poručuju iz Halmeda.
Lijek ellaOne je hitni kontraceptiv koji se koristi za sprječavanje neplanirane trudnoće ako se uzme unutar 120 sati (pet dana) nakon nezaštićenog spolnog odnosa ili zatajenja kontracepcijske metode, no najbolje ga je uzeti u roku od 24 sata. Lijek sprječava ili odgađa ovulaciju, a izdavanje bez recepta trebalo bi povećati njegovu dostupnost kao i učinkovitost. Cijena tablete iznosi 200 kuna. Lijek ellaOne je odobren u EU od 2009. godine, a o rizicima i koristima njegove primjene do danas je prikupljen i obrađen opsežan skup sigurnosnih informacija. Na temelju ocjene dostupnih informacija, CHMP je ocijenio da se lijek ellaOne može sigurno i učinkovito koristiti bez liječničkog recepta.
“Kao žena i direktorica tvrtke, koja je između ostalog posvećena reproduktivnom zdravlju žene, procjenjujem da je ovo prijelomna odluka kojom je po prvi puta u povijesti kontracepcije velikom broju žena omogućen izravan pristup hitnoj kontracepciji.” poručila je direktorica tvrtke Arenda, lokalnog zastupnika lijeka, Lejla Bosak . Dodala je kako je lijek dosad koristilo preko 3 milijuna žena diljem svijeta te da je odobren u više od 70 zemalja. No, upozorava – namijenjen je samo povremenoj uporabi i ne može zamijeniti redovnu kontracepciju. Index …