Overview

The marketing authorisation for Staquis has been withdrawn at the request of the marketing-authorisation holder.

Staquis : EPAR - Medicine overview

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română (RO) (303.92 KB - PDF)
slovenčina (SK) (319.54 KB - PDF)
slovenščina (SL) (317.49 KB - PDF)
Suomi (FI) (279.2 KB - PDF)
svenska (SV) (281.27 KB - PDF)

Staquis : EPAR - Risk-management-plan summary

Product information

Staquis : EPAR - Product Information

български (BG) (1.77 MB - PDF)
español (ES) (652.9 KB - PDF)
čeština (CS) (854.6 KB - PDF)
dansk (DA) (701.91 KB - PDF)
Deutsch (DE) (631.59 KB - PDF)
eesti keel (ET) (632.47 KB - PDF)
ελληνικά (EL) (1.11 MB - PDF)
français (FR) (646.88 KB - PDF)
hrvatski (HR) (686.34 KB - PDF)
íslenska (IS) (603.78 KB - PDF)
italiano (IT) (654.17 KB - PDF)
latviešu valoda (LV) (954.3 KB - PDF)
lietuvių kalba (LT) (666.03 KB - PDF)
magyar (HU) (907.86 KB - PDF)
Malti (MT) (990.45 KB - PDF)
Nederlands (NL) (743.33 KB - PDF)
norsk (NO) (599.01 KB - PDF)
polski (PL) (844.03 KB - PDF)
português (PT) (718.77 KB - PDF)
română (RO) (764.23 KB - PDF)
slovenčina (SK) (932.49 KB - PDF)
slovenščina (SL) (945.75 KB - PDF)
Suomi (FI) (699.75 KB - PDF)
svenska (SV) (617.55 KB - PDF)

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.
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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

български (BG) (201.75 KB - PDF)
español (ES) (186.74 KB - PDF)
čeština (CS) (195.66 KB - PDF)
dansk (DA) (187.51 KB - PDF)
Deutsch (DE) (188.07 KB - PDF)
eesti keel (ET) (186.99 KB - PDF)
ελληνικά (EL) (201.24 KB - PDF)
français (FR) (187.58 KB - PDF)
hrvatski (HR) (186.48 KB - PDF)
íslenska (IS) (187.47 KB - PDF)
italiano (IT) (186.31 KB - PDF)
latviešu valoda (LV) (195.58 KB - PDF)
lietuvių kalba (LT) (187.21 KB - PDF)
magyar (HU) (195.07 KB - PDF)
Malti (MT) (199.97 KB - PDF)
Nederlands (NL) (186.56 KB - PDF)
norsk (NO) (191.95 KB - PDF)
polski (PL) (195.15 KB - PDF)
português (PT) (186.88 KB - PDF)
română (RO) (186.68 KB - PDF)
slovenčina (SK) (195.31 KB - PDF)
slovenščina (SL) (193.6 KB - PDF)
Suomi (FI) (186.56 KB - PDF)
svenska (SV) (186.08 KB - PDF)

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

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

Staquis : EPAR - Public assessment report

CHMP summary of positive opinion for Staquis

Topics

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