Switzerland & European Union — European Medicines Agency

Switzerland: Switzerland is one of the countries where hantavirus patients are being treated.

European Union — European Medicines Agency: The European Union — European Medicines Agency identified favipiravir as the most plausible candidate for hantavirus treatment under clinical trial or compassionate use protocols.

Switzerland: Imlifidase is approved in Switzerland, indicating its presence in key European markets outside the EU.

European Union — European Medicines Agency: The European Union — European Medicines Agency conditionally approved Imlifidase and requested the PAES study, which has now been successfully completed, paving the way for a full marketing authorization application.

Switzerland: Switzerland>>> is one of the regions where SERB Pharmaceuticals>>> will acquire rights to Imlifidase>>>.

European Union — European Medicines Agency: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.

Switzerland: Switzerland is one of the countries where additional regulatory filings are planned for Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.

European Union — European Medicines Agency: The European Union — European Medicines Agency has granted orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification, and priority medicines (PRIME) designation to Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.

Switzerland: Switzerland stopped recommending COVID-19 vaccines for spring and summer, even for high-risk groups, citing high immunity.

European Union — European Medicines Agency: EMA oversees vaccine safety in the EU and received confidential documents from BioNTech regarding adverse events, but the policy change is a national decision.

Switzerland: Switzerland is included in the licensing agreement, providing access to a developed pharmaceutical market.

European Union — European Medicines Agency: The EMA accepted the Marketing Authorisation Application for senaparib, a regulatory step that is critical for European Union — European market entry. Approval is expected in H2 2026.

Switzerland: Imlifidase is approved in Switzerland, expanding its global reach.

European Union — European Medicines Agency: The European Union — European Medicines Agency reviewed IDEFIRIX as part of its PRIority Medicines program, supporting its conditional marketing approval in Europe.

Switzerland: Switzerland is another market where Idefirix is approved, part of the product's global regulatory approvals.

European Union — European Medicines Agency: The EMA's prior conditional approval and PRIME designation support Idefirix's regulatory standing in Europe, though not directly impacted by this event.

Switzerland: Switzerland is a member of the European Free Trade Association, with which India has implemented a trade pact.

European Union — European Medicines Agency: Indian generic medicines approved by the European Union — European Medicines Agency>>> will receive fast-track marketing authorization in Oman>>> under the CEPA.