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.
Protopic : EPAR - Summary for the public (PDF/112.64 KB)
First published: 06/07/2009
Last updated: 16/08/2011
Protopic : EPAR - Risk-management-plan summary (PDF/1.99 MB)
First published: 07/09/2020
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LEO Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
23/07/2020 Protopic - EMEA/H/C/000374 - II/0083/G
- 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.
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Other dermatological preparations
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 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).