Product Approval
🌍 AU/AMA Level
Continental Listing: SOLIRIS
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for SOLIRIS (AMA0047).
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Eculizumab
Indication: Treatment of Paroxysmal nocturnal haemoglobinuria (PNH), Atypical haemolytic uremic syndrome (aHUS), Refractory generalized myasthenia gravis (gMG), Neuromyelitis optica spectrum disorder (NMOSD)
This product was listed in the 3rd Edition - October 2025 and is now available for country-level submissions.
Manufacturing Sites: Patheon Italia S.p.A, Italy; Alexion Dublin Manufacturing Facility (ADMF), Dublin Ireland
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Complement inhibitor and monoclonal antibody
Applicant: AstraZeneca Pharmaceuticals (Pty) Ltd
Active Substance: Eculizumab
Indication: Treatment of Paroxysmal nocturnal haemoglobinuria (PNH), Atypical haemolytic uremic syndrome (aHUS), Refractory generalized myasthenia gravis (gMG), Neuromyelitis optica spectrum disorder (NMOSD)
This product was listed in the 3rd Edition - October 2025 and is now available for country-level submissions.
Manufacturing Sites: Patheon Italia S.p.A, Italy; Alexion Dublin Manufacturing Facility (ADMF), Dublin Ireland
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Complement inhibitor and monoclonal antibody
Tags:
continental listing
emp-tc
category
1:
complement
inhibitor
and
monoclonal
antibody
L04AJ01
Published: October 20, 2025
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