Staquis

RSS
Withdrawn

This medicine's authorisation has been withdrawn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The European Public Assessment Report (EPAR) for Staquis is updated to indicate that the marketing authorisation is no longer valid.

Staquis : EPAR - Medicine overview

Reference Number: EMA/64649/2020

English (EN) (283.45 KB - PDF)

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български (BG) (328.69 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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español (ES) (281.81 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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čeština (CS) (320.82 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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dansk (DA) (281.27 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Deutsch (DE) (285.3 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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eesti keel (ET) (270.41 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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ελληνικά (EL) (329.52 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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français (FR) (283.57 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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hrvatski (HR) (303.39 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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italiano (IT) (280.3 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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latviešu valoda (LV) (329.73 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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lietuvių kalba (LT) (305.64 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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magyar (HU) (318.99 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Malti (MT) (320.18 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Nederlands (NL) (282.3 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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polski (PL) (321.05 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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português (PT) (283.06 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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română (RO) (303.92 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenčina (SK) (319.54 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenščina (SL) (317.49 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Suomi (FI) (279.2 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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svenska (SV) (281.27 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Staquis : EPAR - Risk-management-plan summary

English (EN) (221.92 KB - PDF)

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Product information

Staquis : EPAR - Product Information

English (EN) (824.49 KB - PDF)

First published: Last updated:
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български (BG) (1.77 MB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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español (ES) (652.9 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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čeština (CS) (854.6 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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dansk (DA) (701.91 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Deutsch (DE) (631.59 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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eesti keel (ET) (632.47 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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ελληνικά (EL) (1.11 MB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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français (FR) (646.88 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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hrvatski (HR) (686.34 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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íslenska (IS) (603.78 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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italiano (IT) (654.17 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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latviešu valoda (LV) (954.3 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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lietuvių kalba (LT) (666.03 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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magyar (HU) (907.86 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Malti (MT) (990.45 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Nederlands (NL) (743.33 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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norsk (NO) (599.01 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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polski (PL) (844.03 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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português (PT) (718.77 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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română (RO) (764.23 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenčina (SK) (932.49 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenščina (SL) (945.75 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Suomi (FI) (699.75 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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svenska (SV) (617.55 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Latest procedure affecting product information:N/0006
01/10/2021
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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:
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български (BG) (201.75 KB - PDF)

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

español (ES) (186.74 KB - PDF)

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

čeština (CS) (195.66 KB - PDF)

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

dansk (DA) (187.51 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Deutsch (DE) (188.07 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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eesti keel (ET) (186.99 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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ελληνικά (EL) (201.24 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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français (FR) (187.58 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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hrvatski (HR) (186.48 KB - PDF)

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

íslenska (IS) (187.47 KB - PDF)

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

italiano (IT) (186.31 KB - PDF)

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

latviešu valoda (LV) (195.58 KB - PDF)

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

lietuvių kalba (LT) (187.21 KB - PDF)

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

magyar (HU) (195.07 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Malti (MT) (199.97 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Nederlands (NL) (186.56 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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norsk (NO) (191.95 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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polski (PL) (195.15 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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português (PT) (186.88 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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română (RO) (186.68 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenčina (SK) (195.31 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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slovenščina (SL) (193.6 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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Suomi (FI) (186.56 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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svenska (SV) (186.08 KB - PDF)

First published: 22/04/2020 Last updated: 08/02/2022
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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:
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Staquis-H-C-4863-P46-006: EPAR - Assessment report

Adopted Reference Number: EMA/717595/2021

English (EN) (4.25 MB - PDF)

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

Adopted Reference Number: EMA/702062/2021

English (EN) (1.64 MB - PDF)

First published: Last updated:
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Staquis-H-C-4863-P46-002 : EPAR - Assessment report

Adopted Reference Number: EMA/662601/2021

English (EN) (3.8 MB - PDF)

First published: Last updated:
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Staquis-H-C-4863-P46-003 : EPAR - Assessment report

Adopted Reference Number: EMA/591235/2020

English (EN) (2.89 MB - PDF)

First published: Last updated:
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Staquis : EPAR - Public assessment report

Adopted Reference Number: EMA/88816/2020

English (EN) (7.86 MB - PDF)

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CHMP summary of positive opinion for Staquis

Adopted Reference Number: EMA/CHMP/35206/2020

English (EN) (714.59 KB - PDF)

First published: Last updated:
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