About this medicine
- Approved name
- Hydroxyprogesterone caproate-containing medicinal products
- International non-proprietary name (INN) or common name
- hydroxyprogesterone caproate
- Associated names
- Lentogest
- Progesterone Retard Pharlon
- Proluton Depot
- Class
- progestogens
About this procedure
- Current status
- Recommendation provided by Pharmacovigilance Risk Assessment Committee
- Reference number
- EMEA-H-A-31-1528
- Type
- Article 31 referrals
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
- Authorisation model
- Nationally authorised product(s)
- Decision making model
- PRAC-CMDh
Key dates and outcomes
- Procedure start date
- 12/05/2023
- PRAC recommendation date
- 16/05/2024
- Outcome
- Suspension