Overview
The marketing authorisation for Staquis has been withdrawn at the request of the marketing-authorisation holder.
Staquis : EPAR - Medicine overview
Staquis : EPAR - Risk-management-plan summary
Product information
Staquis : EPAR - 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).
Staquis : EPAR - All Authorised presentations
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.
Assessment history
Staquis : EPAR - Procedural steps taken and scientific information after authorisation
Staquis-H-C-4863-P46-006: EPAR - Assessment report
Staquis-H-C-4863-P46-005: EPAR - Assessment report
Staquis-H-C-4863-P46-002 : EPAR - Assessment report
Staquis-H-C-4863-P46-003 : EPAR - Assessment report