Product Approval
🌍 AU/AMA Level
Continental Listing: TRUQAP 160mg
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for TRUQAP 160mg (AMA00008).
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Capivasertib
Indication: In combination with fulvestrant for ER-positive, HER2-negative locally advanced/metastatic breast cancer with PIK3CA, AKT1 or PTEN alterations
This product was listed in the 2nd Edition - July 2025 and is now available for country-level submissions.
Manufacturing Sites: AstraZeneca AB, Södertälje, Sweden
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Antineoplastic agent, protein kinase inhibitor
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Capivasertib
Indication: In combination with fulvestrant for ER-positive, HER2-negative locally advanced/metastatic breast cancer with PIK3CA, AKT1 or PTEN alterations
This product was listed in the 2nd Edition - July 2025 and is now available for country-level submissions.
Manufacturing Sites: AstraZeneca AB, Södertälje, Sweden
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Antineoplastic agent, protein kinase inhibitor
Tags:
continental listing
emp-tc
category
1:
antineoplastic
agent
protein
kinase
inhibitor
L01EX27
Published: July 17, 2025
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