Staquis
Withdrawn
This medicine's authorisation has been withdrawn
crisaborole
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 31 January 2022, the European Commission withdrew the marketing authorisation for Staquis (crisaborole) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Europe MA EEIG, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Staquis was granted marketing authorisation in the EU on 27 March 2020 for the treatment of mild to moderate atopic dermatitis. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU.
The European Public Assessment Report (EPAR) for Staquis is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0006
01/10/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Staquis
- Active substance
- Crisaborole
- International non-proprietary name (INN) or common name
- crisaborole
- Therapeutic area (MeSH)
- Dermatitis, Atopic
- Anatomical therapeutic chemical (ATC) code
- D11AH06
Pharmacotherapeutic group
Other dermatological preparationsTherapeutic indication
Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ? 40% body surface area (BSA) affected.
News on Staquis
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