Product Approval
🌍 AU/AMA Level
Continental Listing: Gardasil 9 (Prefilled Syringe)
A
AMRH Secretariat
African Medicines Regulatory Harmonization (AMRH)
AMRH has granted a Positive Opinion for Gardasil 9 (Prefilled Syringe) (AMA0044).
Applicant: MSD (Pty) Ltd
Active Substance: Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58
Indication: Active immunisation from age 9 years against HPV diseases: premalignant lesions and cancers of cervix, vulva, vagina, anus; genital warts
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: Merck Sharp & Dohme LLC, West Point, Pennsylvania, USA; MSD Ireland, Carlow, Ireland; Release: Merck Sharp & Dohme B.V., Haarlem, Netherlands
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Vaccine
Applicant: MSD (Pty) Ltd
Active Substance: Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58
Indication: Active immunisation from age 9 years against HPV diseases: premalignant lesions and cancers of cervix, vulva, vagina, anus; genital warts
This product was listed in the 1st Edition - March 2025 and is now available for country-level submissions.
Manufacturing Sites: Merck Sharp & Dohme LLC, West Point, Pennsylvania, USA; MSD Ireland, Carlow, Ireland; Release: Merck Sharp & Dohme B.V., Haarlem, Netherlands
GMP Status: Compliant
Therapeutic Category: EMP-TC Category 1: Vaccine
Tags:
continental listing
emp-tc
category
1:
vaccine
J07BM03
Published: March 25, 2025
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