Case Study: EC’s conditional marketing approval to Libtayo for advanced CSCC
Posted on02 Jul 2019
Tagscemiplimab, Conditional marketing authorisation, EU marketing authorization, Libtayo, MAB, Regeneron, Sanofi
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The European Commission (EC) has granted conditional marketing authorization for Libtayo (cemiplimab) for the treatment of adults with metastatic or locally advanced... Read More
What is Conditional marketing authorisation by European Medicine Agency?
The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs of patients. In the interest of public... Read More
Case analysis: Can marketing authorization can be revoked?
Yes. Marketing authorization can be revoked and it generally carried out, in case of safety issued observed with the molecule. Here is... Read More
The ‘sunset clause’ for marketing authorisations of pharmaceuticals
This clause comes under European Drug Regulatory Affairs. Under the ‘sunset clause’ of Article 24(4) to (6) of Directive 2001/83/EC, any marketing... Read More
Gilead’s single tablet regimen Odefsey got EU marketing authorization for HIV treatment
The European Commission has granted marketing authorization for Gilead Sciences’ once-daily single tablet regimen (STR) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide... Read More