Commenting on the news, Dr Conrad Savoy, Biopartners’ CEO said: “We are very satisfied indeed to have received European marketing authorisation for Ribavirin Biopartners. This approval marks an important milestone, both for Biopartners and also for European healthcare providers, as it ushers in a new era of lower cost therapy.” Dr Savoy continued: “The granting of the EU marketing authorisation completes a very efficient and successful review procedure, with Ribavirin Biopartners receiving a positive opinion from the CHMP in only eight months. We believe this fast review and approval process underlines the strength of the data presented.”
The studies submitted in the application dossier demonstrated the appropriate quality of Ribavirin Biopartners 200mg film-coated tablets and its bioequivalence with the reference product – RebetolĀ®.