Product Approval
🌍 AU/AMA Level
Continental Listing: Keytruda
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for Keytruda (AMA0046).
Applicant: MSD (Pty) Ltd
Active Substance: Pembrolizumab
Indication: Treatment of Melanoma, NSCLC, Classical Hodgkin lymphoma, Urothelial carcinoma, HNSCC, RCC, MSI-H/dMMR cancers, CRC, Oesophageal carcinoma, TNBC, Endometrial carcinoma, Cervical cancer, Gastric/GEJ adenocarcinoma, Biliary tract carcinoma
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: MSD Ireland, Carlow, Ireland; Release: Merck Sharp & Dohme B.V., Haarlem, Netherlands
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Immunotherapy
Applicant: MSD (Pty) Ltd
Active Substance: Pembrolizumab
Indication: Treatment of Melanoma, NSCLC, Classical Hodgkin lymphoma, Urothelial carcinoma, HNSCC, RCC, MSI-H/dMMR cancers, CRC, Oesophageal carcinoma, TNBC, Endometrial carcinoma, Cervical cancer, Gastric/GEJ adenocarcinoma, Biliary tract carcinoma
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: MSD Ireland, Carlow, Ireland; Release: Merck Sharp & Dohme B.V., Haarlem, Netherlands
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Immunotherapy
Tags:
continental listing
emp-tc
category
1:
immunotherapy
L01FF02
Published: March 25, 2025
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