Protopic

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tacrolimus

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Protopic. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protopic.

This EPAR was last updated on 03/09/2018

Authorisation details

Product details
Name
Protopic
Agency product number
EMEA/H/C/000374
Active substance
tacrolimus
International non-proprietary name (INN) or common name
tacrolimus
Therapeutic area (MeSH)
Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code
D11AH01
Publication details
Marketing-authorisation holder
LEO Pharma A/S
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
27/02/2002
Contact address
Industriparken 55
2750 Ballerup
Denmark

Product information

29/06/2018 Protopic - EMEA/H/C/000374 - IB/0075

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER DERMATOLOGICAL PREPARATIONS

Therapeutic indication

Flare treatment

Adults and adolescents (16 years of age and above)

Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.

Children (two years of age and above)

Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.

Maintenance treatment

Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

Assessment history

Changes since initial authorisation of medicine

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