✉news WorldEU Politics first seen 1 d ago, last 1 d ago, peak #31
Hansoh to refile Aumseqa in EU after approval revoked
Original: Hansoh plans new EU filing after Aumseqa approval revoked
Chinese drugmaker Hansoh Pharmaceutical says it plans to submit a new marketing application to the European Medicines Agency after the EU approval of Aumseqa was revoked. The company is seeking to regain a foothold in the European market for the medicine, though details of the refiled application and its chances of success have not been disclosed.
Why now: The revocation of an EU approval for a major Chinese pharmaceutical company's product is unusual and raises questions about regulatory standards for Chinese drugmakers in Europe.
Hansoh PharmaceuticalAumseqaEuropean Medicines AgencyEuropean Union
Evidence
- Hansoh plans new EU filing after Aumseqa approval revoked · The Pharma Letter
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