Biopartners GmbH has announced that it has received EU marketing authorization from the European Commission for Ribavirin Biopartners 200mg film-coated tablets. The product is intended for the treatment of chronic hepatitis C infection as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b.
“We are very satisfied indeed to have received European marketing authorization 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.”
Commenting on the news, Dr Conrad Savoy, Biopartners' CEO said: "We are very satisfied indeed to have received European marketing authorization 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 authorization completes a very efficient and successful review procedure, with Ribavirin Biopartners receiving a positive opinion from the CHMP in only 8 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 - Rebetol®.
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