Product Approval
🌍 AU/AMA Level
Continental Listing: IMFINZI
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for IMFINZI (AMA0050).
Applicant: AstraZeneca UK Limited
Active Substance: Durvalumab
Indication: Treatment of unresectable Stage III NSCLC; First-line treatment of extensive-stage SCLC (with etoposide and carboplatin/cisplatin); Treatment of locally advanced/metastatic biliary tract cancer (with gemcitabine and cisplatin)
This product was listed in the 3rd Edition - October 2025 and is now available for country-level submissions.
Manufacturing Sites: AstraZeneca AB, Södertälje, Sweden
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Monoclonal antibodies
Applicant: AstraZeneca UK Limited
Active Substance: Durvalumab
Indication: Treatment of unresectable Stage III NSCLC; First-line treatment of extensive-stage SCLC (with etoposide and carboplatin/cisplatin); Treatment of locally advanced/metastatic biliary tract cancer (with gemcitabine and cisplatin)
This product was listed in the 3rd Edition - October 2025 and is now available for country-level submissions.
Manufacturing Sites: AstraZeneca AB, Södertälje, Sweden
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Monoclonal antibodies
Tags:
continental listing
emp-tc
category
1:
monoclonal
antibodies
L01FF03
Published: October 20, 2025
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