Şunu aradınız:: alpheon (İngilizce - Maltaca)

what is alpheon?
x’ inhu alpheon?

how is alpheon expected to work?
kif inhu mistenni li jaħdem alpheon?

what was alpheon expected to be used for?
għal x’ hiex kien mistenni li jintuża alpheon?

alpheon was developed as a ‘ biosimilar’ medicine.
alpheon ġie żviluppat bħala mediċina ‘ bijosimili ’.

hence, the chmp recommended that alpheon be refused marketing authorisation.
għaldaqstant, il- chmp irrikmanda li alpheon ma jingħatax l- awtorizzazzjoni għat- tqegħid fis- suq.

questions and answers on recommendation for refusal of marketing application for alpheon
mistoqsijiet u tweĠibiet dwar ir- rakkomandazzjoni gĦal rifjut ta ’ applikazzjoni gĦat- tqegĦid fis- suq għal alpheon

alpheon is a solution for injection that contains the active substance interferon alfa-2a.
alpheon huwa soluzzjoni għal injezzjoni li fiha s- sustanza attiva interferon alfa- 2a.

alpheon was to be used with an antiviral medicine, ribavirin, except when patients could not take ribavirin.
alpheon kellu jintuża b’ mediċina antivirali, ribavirin, għajr meta l- pazjenti ma setgħux jieħdu ribavirin.

what are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with alpheon?
x’ inhuma l- konsegwenza tar- rifjut għal pazjenti li jkunu qegħdin jagħmlu provi kliniċi/ programm ta ’ użu ta ’ kompassjoni b’ alpheon?

the number of patients with hepatitis c responding to treatment with alpheon and roferon-a was similar in the clinical study.
in- numru ta ’ pazjenti b’ epatite Ċ li kellhom rispons għall- kura b’ alpheon u roferon- a kien simili fl - istudju kliniku.

at this point in time, the chmp was of the opinion that alpheon could not be considered as a biosimilar medicine of roferon-a, the reference medicinal product.
f’ dan iż- żmien, il- chmp kien ta ’ l- opinjoni li alpheon ma setax jiġi kkunsidrat bħala mediċina bijosimili ta ’ roferon- a, il- prodott mediċinali ta ’ referenza.

the chmp had major concerns regarding the comparability of alpheon and roferon-a, because of differences identified between the two medicines (such as impurities).
il- chmp kellu tħassib ewlieni fir- rigward tal- komparabbiltà ta ’ alpheon u oferon- a, minħabba d - differenzi identifikati bejn iż- żewġ mediċini (bħal impuritajiet).

however, some differences were seen between the two medicines: more patients experienced a return of the disease after treatment with alpheon was stopped than with the reference medicine, and there were more side effects with alpheon.
madankollu, ġew osservati xi differenzi bejn iż- żewġ mediċini: aktar pazjenti esperjenzaw il- feġġa mill- ġdid tal- marda wara li l- kura b’ alpheon twaqqfet milli bil- mediċina ta ’ referenza, u kien hemm aktar effetti sekondarji b’ alpheon.

on 28 june 2006 the committee for medicinal products for human use (chmp) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product alpheon 6 million iu/ ml solution for injection intended for the treatment of hepatitis c.
fit- 28 ta ’ Ġunju 2006, il- kumitat għal prodotti mediċinali għal użu mill- bniedem (chmp) adotta opinjoni negattiva, u rrikmanda r- rifjut ta ’ l- awtorizzazzjoni tat- tqegħid fis- suq għall- prodott mediċinali alpheon 6 miljun iu/ ml soluzzjoni għal injezzjoni maħsuba għat- trattament ta ’ l- epatite Ċ.