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what is alpheon?
x’ inhu alpheon?
最后更新: 2012-04-10
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how is alpheon expected to work?
kif inhu mistenni li jaħdem alpheon?
最后更新: 2012-04-10
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what was alpheon expected to be used for?
għal x’ hiex kien mistenni li jintuża alpheon?
最后更新: 2012-04-10
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alpheon was developed as a ‘ biosimilar’ medicine.
alpheon ġie żviluppat bħala mediċina ‘ bijosimili ’.
最后更新: 2011-10-23
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hence, the chmp recommended that alpheon be refused marketing authorisation.
għaldaqstant, il- chmp irrikmanda li alpheon ma jingħatax l- awtorizzazzjoni għat- tqegħid fis- suq.
最后更新: 2012-04-10
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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
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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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?
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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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).
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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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.
最后更新: 2012-04-10
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