Overview

The marketing authorisation for Staquis has been withdrawn at the request of the marketing-authorisation holder.

Staquis : EPAR - Medicine overview

Reference Number: EMA/64649/2020

English (EN) (283.45 KB - PDF)

First published: Last updated:
View

български (BG) (328.69 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

español (ES) (281.81 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

čeština (CS) (320.82 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

dansk (DA) (281.27 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Deutsch (DE) (285.3 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

eesti keel (ET) (270.41 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

ελληνικά (EL) (329.52 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

français (FR) (283.57 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

hrvatski (HR) (303.39 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

italiano (IT) (280.3 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

latviešu valoda (LV) (329.73 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

lietuvių kalba (LT) (305.64 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

magyar (HU) (318.99 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Malti (MT) (320.18 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Nederlands (NL) (282.3 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

polski (PL) (321.05 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

português (PT) (283.06 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

română (RO) (303.92 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenčina (SK) (319.54 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenščina (SL) (317.49 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Suomi (FI) (279.2 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

svenska (SV) (281.27 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Staquis : EPAR - Risk-management-plan summary

English (EN) (221.92 KB - PDF)

First published: Last updated:
View

Product information

Staquis : EPAR - Product Information

English (EN) (824.49 KB - PDF)

First published: Last updated:
View

български (BG) (1.77 MB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

español (ES) (652.9 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

čeština (CS) (854.6 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

dansk (DA) (701.91 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Deutsch (DE) (631.59 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

eesti keel (ET) (632.47 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

ελληνικά (EL) (1.11 MB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

français (FR) (646.88 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

hrvatski (HR) (686.34 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

íslenska (IS) (603.78 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

italiano (IT) (654.17 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

latviešu valoda (LV) (954.3 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

lietuvių kalba (LT) (666.03 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

magyar (HU) (907.86 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Malti (MT) (990.45 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Nederlands (NL) (743.33 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

norsk (NO) (599.01 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

polski (PL) (844.03 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

português (PT) (718.77 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

română (RO) (764.23 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenčina (SK) (932.49 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenščina (SL) (945.75 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Suomi (FI) (699.75 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

svenska (SV) (617.55 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Latest procedure affecting product information: N/0006

01/10/2021

icon globe

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

English (EN) (195.86 KB - PDF)

First published: Last updated:
View

български (BG) (201.75 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

español (ES) (186.74 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

čeština (CS) (195.66 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

dansk (DA) (187.51 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Deutsch (DE) (188.07 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

eesti keel (ET) (186.99 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

ελληνικά (EL) (201.24 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

français (FR) (187.58 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

hrvatski (HR) (186.48 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

íslenska (IS) (187.47 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

italiano (IT) (186.31 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

latviešu valoda (LV) (195.58 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

lietuvių kalba (LT) (187.21 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

magyar (HU) (195.07 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Malti (MT) (199.97 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Nederlands (NL) (186.56 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

norsk (NO) (191.95 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

polski (PL) (195.15 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

português (PT) (186.88 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

română (RO) (186.68 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenčina (SK) (195.31 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

slovenščina (SL) (193.6 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

Suomi (FI) (186.56 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

svenska (SV) (186.08 KB - PDF)

First published: 22/04/2020Last updated: 08/02/2022
View

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 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.

Authorisation details

EMA product number
EMEA/H/C/004863
Marketing authorisation holder
Pfizer Europe MA EEIG 

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Opinion adopted
30/01/2020
Marketing authorisation issued
27/03/2020
Revision
6

Assessment history

Staquis : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (648.05 KB - PDF)

First published: Last updated:
View

Staquis-H-C-4863-P46-006: EPAR - Assessment report

AdoptedReference Number: EMA/717595/2021

English (EN) (4.25 MB - PDF)

First published: Last updated:
View

Staquis-H-C-4863-P46-005: EPAR - Assessment report

AdoptedReference Number: EMA/702062/2021

English (EN) (1.64 MB - PDF)

First published: Last updated:
View

Staquis-H-C-4863-P46-002 : EPAR - Assessment report

AdoptedReference Number: EMA/662601/2021

English (EN) (3.8 MB - PDF)

First published: Last updated:
View

Staquis-H-C-4863-P46-003 : EPAR - Assessment report

AdoptedReference Number: EMA/591235/2020

English (EN) (2.89 MB - PDF)

First published: Last updated:
View

Staquis : EPAR - Public assessment report

AdoptedReference Number: EMA/88816/2020

English (EN) (7.86 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Staquis

AdoptedReference Number: EMA/CHMP/35206/2020

English (EN) (714.59 KB - PDF)

First published: Last updated:
View

More information on Staquis

Public statement on Staquis : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/78551/2022

English (EN) (111.38 KB - PDF)

First published:
View

Topics

This page was last updated on

Share this page