About this medicine
- Approved name
- Quinolone- and fluoroquinolone-containing medicinal products
- International non-proprietary name (INN) or common name
- nalidixic acid
- pipemidic acid
- cinoxacin
- enoxacin
- pefloxacin
- lomefloxacin
- ciprofloxacin
- levofloxacin
- ofloxacin
- moxifloxacin
- norfloxacin
- prulifloxacin
- rufloxacin
- flumequin
- Associated names
- Quinsair
- Class
- Quinolones and fluoroquinolones
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-31/1452
- 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
- Centrally and nationally authorised products (mixed)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 09/02/2017
- PRAC recommendation date
- 04/10/2018
- CHMP opinion date
- 15/11/2018
- EC decision date
- 11/03/2019
- Outcome
- Risk minimisation measures