Product Approval
🌍 AU/AMA Level
Continental Listing: STRENSIQ 40 mg/ml
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for STRENSIQ 40 mg/ml (AMA0048).
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Asfotase alfa
Indication: Long-term enzyme replacement therapy for paediatric-onset hypophosphatasia to treat bone manifestations
This product was listed in the 2nd Edition - July 2025 and is now available for country-level submissions.
Manufacturing Sites: API: Lonza Biologics Inc. (USA), Alexion Pharma (Ireland); FPP: Alexion Pharma (Ireland), Patheon, Italy
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Enzyme replacement therapy
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Asfotase alfa
Indication: Long-term enzyme replacement therapy for paediatric-onset hypophosphatasia to treat bone manifestations
This product was listed in the 2nd Edition - July 2025 and is now available for country-level submissions.
Manufacturing Sites: API: Lonza Biologics Inc. (USA), Alexion Pharma (Ireland); FPP: Alexion Pharma (Ireland), Patheon, Italy
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Enzyme replacement therapy
Tags:
continental listing
emp-tc
category
1:
enzyme
replacement
therapy
A16AB13
Published: July 17, 2025
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