Refused
This medicine was refused authorisation for use in the European Union.
Overview
After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Ipique. The medicine was intended for the treatment of neovascular (wet) age-related macular degeneration (AMD).
The Agency issued its opinion after re-examination on 24 February 2022. The Agency had issued its initial opinion on 11 November 2021. The company that applied for authorisation of Ipique is Rotterdam Biologics B.V.
This EPAR was last updated on 24/05/2022
Application details
Product details | |
---|---|
Name |
Ipique
|
Active substance |
bevacizumab
|
International non-proprietary name (INN) or common name |
bevacizumab
|
Therapeutic area (MeSH) |
Wet Macular Degeneration
|
Anatomical therapeutic chemical (ATC) code |
S01LA04
|
Application details | |
---|---|
Marketing-authorisation applicant |
Rotterdam Biologics B.V.
|
Date of opinion |
16/12/2021
|
Date of refusal of marketing authorisation |
29/04/2022
|