Staquis
crisaborole
Table of contents
Overview
The marketing authorisation for Staquis has been withdrawn at the request of the marketing-authorisation holder.
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List item
Staquis : EPAR - Medicine overview (PDF/283.45 KB)
First published: 22/04/2020
Last updated: 08/02/2022
EMA/64649/2020 -
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List item
Staquis : EPAR - Risk-management-plan summary (PDF/221.92 KB)
First published: 22/04/2020
Last updated: 08/02/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Staquis
|
| Agency product number |
EMEA/H/C/004863
|
| Active substance |
Crisaborole
|
| International non-proprietary name (INN) or common name |
crisaborole
|
| Therapeutic area (MeSH) |
Dermatitis, Atopic
|
| Anatomical therapeutic chemical (ATC) code |
D11AH06
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
| Revision |
6
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/03/2020
|
| Contact address |
Pfizer Europe MA EEIG |
Product information
01/10/2021 Staquis - EMEA/H/C/004863 - N/0006
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other dermatological preparations
Therapeutic 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.