Product Approval
🌍 AU/AMA Level
Continental Listing: Bavencio
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for Bavencio (AMA0043).
Applicant: Merck (Pty) Ltd
Active Substance: Avelumab
Indication: Monotherapy for metastatic Merkel cell carcinoma (MCC); First-line maintenance for locally advanced/metastatic urothelial carcinoma (UC); Combination with Axitinib for advanced renal cell carcinoma (RCC)
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: Merck Serono S.A., Succursale d'Aubonne, Zone Industrielle de l'Ouriettaz, 1170 Aubonne, Switzerland
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Immunotherapy
Applicant: Merck (Pty) Ltd
Active Substance: Avelumab
Indication: Monotherapy for metastatic Merkel cell carcinoma (MCC); First-line maintenance for locally advanced/metastatic urothelial carcinoma (UC); Combination with Axitinib for advanced renal cell carcinoma (RCC)
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: Merck Serono S.A., Succursale d'Aubonne, Zone Industrielle de l'Ouriettaz, 1170 Aubonne, Switzerland
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Immunotherapy
Tags:
continental listing
emp-tc
category
1:
immunotherapy
L01FF04
Published: March 25, 2025
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