About this medicine
- Approved name
- Fusafungine containing medicinal products for oromucosal and nasal use
- International non-proprietary name (INN) or common name
- fusafungine
- Class
- -
About this procedure
- Current status
- CMDh final position
- Reference number
- EMEA/H/A-31/1420
- 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
- 10/09/2015
- PRAC recommendation date
- 11/02/2016
- CHMP opinion date
- 31/03/2016
- Outcome
- Revocation