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INDUSTRY:

Pharma

TOPIC:

Regulatory & Legal

TITLE:

EMA: Human medicines European public assessment report (EPAR): Viekirax (ombitasvir / paritaprevir / ritonavir) - Revision: 9 - Authorised

BRIEF:

EMA published the approvals of changes - the sections 4.8 and 5.1 of the SmPC are updated to reflect the main results of study M14-226 (RUBY-I). In addition, the MAH took the opportunity to make a correction in the product information of Viekirax.

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