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Phenergan 5mg/5ml oral solution & Phenergan 25mg film-coated tablets

20/06/2025
Medicines for human use Product information update (PIU)

This update is to inform healthcare professionals of the restriction of Phenergan oral formulation for use in children less than 6 years of age (removal of posology, new adverse events and new warnings/precautions)

Product information

Product name
Phenergan 5mg/5ml oral solution & Phenergan 25mg film-coated tablets
Active substance
promethazine hydrochloride
Authorisation holder
Opella Healthcare France SAS
Authorisation number

PA23180/011/001

PA23180/011/002

Human or veterinary medicine
Human Medicine

Documents

Opens in new window Phenergan Product Information Update June 2025 PDF : 118KB | 19/06/2025