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Van Doren коренной житель
в ответ Julcka 11.05.21 15:15
https://www.ema.europa.eu/en/human-regulatory/marketing-au...
EMA's CHMP may grant a conditional marketing authorisation for a medicine if it finds that all of the following criteria are met:
- the benefit-risk balance of the medicine is positive; - для детей условие не выполнено
- it is likely that the applicant will be able to provide comprehensive data post-authorisation;
- the medicine fulfils an unmet medical need; - при наличии эффективного лечения и профилактики (ивермектин в профилактике показал эффективность 89-98%) не выполнено
- the benefit of the medicine's immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
И FDA: FDA may authorize unapproved medical products or unapproved uses of
approved medical products to be used in an emergency to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
CBRN threat agents when certain criteria are met, including there are
no adequate, approved, and available alternatives.