Protopic

tacrolimus

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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.

What is Protopic?

Protopic is an ointment that contains the active substance tacrolimus (0.1% and 0.03%).

What is Protopic used for?

Protopic is used to treat ‘flare-ups’ (recurrence or worsening) of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin). ‘Atopic’ means that the dermatitis is linked to an allergy. Protopic is used in patients aged two years and above who do not respond well to or do not tolerate conventional treatments such as locally applied corticosteroids.

Protopic can also be used to prevent flare-ups of the disease or prolong the time that patients are free from flare-ups. In maintenance treatment, it is used in patients who usually have four or more flare-ups per year and who have had a response to an initial course of Protopic used twice a day for up to six weeks.

While Protopic 0.03% can be used in all patients over two years of age, Protopic 0.1% is only used in adults and adolescents over 16 years of age.

The medicine can only be obtained with a prescription.

How is Protopic used?

Protopic should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis. The ointment should be applied as a thin layer to the skin.

When used for flare-ups, Protopic can be used for short-term and intermittent long-term treatment, but it should not be used continuously on a long-term basis. Protopic treatment should begin as soon as symptoms appear. Each affected area is treated twice a day with Protopic until the skin is clear. Generally, improvement is seen within one week of starting treatment. If there is no improvement after two weeks, the doctor should consider other treatment options. Children should use Protopic 0.03% twice a day for up to three weeks before reducing the frequency to once a day. Adults should start treatment with Protopic 0.1% twice a day but should switch to less frequent application or use of the lower strength (0.03%) as the condition improves.

When used as maintenance treatment, Protopic should be applied twice a week to areas of the skin commonly affected by the disease. If there are signs of a flare-up, treatment should revert to twice a day as above. The doctor should review the need to continue maintenance treatment after a year. In children, this should include suspension of treatment to allow the doctor to assess whether continued treatment for the disease is necessary.

How does Protopic work?

The way in which Protopic works in atopic dermatitis is not fully understood. The active substance in Protopic, tacrolimus, is an immunomodulator. This means that it works on the immune system (the body’s natural defences). Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ). In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness and dryness). Tacrolimus reduces the activity of the immune system, helping to relieve the skin inflammation and the itching.

How has Protopic been studied?

The use of Protopic in the treatment of flare-ups has been studied in six main studies involving 1,202 patients over the age of 16 years, and 1,535 aged from two to 16 years. Protopic was compared either with placebo (a dummy treatment) or with hydrocortisone (a corticosteroid often used for eczema). The main measure of effectiveness was the improvement in the eczema seen at the end of the studies, after three or 12 weeks, using a scoring system that looks at all of the symptoms of atopic dermatitis. Another study looked at the repeated use of Protopic for up to four years in about 800 patients.

Maintenance treatment with Protopic has been studied in two main studies involving 224 patients aged 16 years or over, and 250 aged from two to 15 years. All of the patients had atopic dermatitis that had responded to a maximum of six weeks of previous treatment with Protopic. The studies compared twice-weekly Protopic with placebo, although both groups of patients could use Protopic whenever they had a flare-up of the disease. The main measure of effectiveness was the number of flare-ups the patients had over a year.

What benefit has Protopic shown during the studies?

In the treatment of flare-ups of atopic dermatitis, Protopic was more effective than hydrocortisone at producing improvements in symptoms, although it also produced more burning than hydrocortisone. In the longer study, Protopic could be used repeatedly without losing its effectiveness.

In maintenance treatment, Protopic was more effective than placebo at reducing the number of flare-ups. In both studies, the patients with moderate to severe disease who were using Protopic had an average of one flare-up over a year, compared with three in those using placebo.

What is the risk associated with Protopic?

The most common side effects with Protopic (seen in more than 1 patient in 10) are a burning sensation and itching at the application site. For the full list of all the side effects reported with Protopic, see the package leaflet.

Protopic should not be used in people who may be hypersensitive (allergic) to tacrolimus, any of the other ingredients or macrolides.

Why has Protopic been approved?

The CHMP decided that Protopic’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Protopic

The European Commission granted a marketing authorisation valid throughout the European Union for Protopic on 28 February 2002.

For more information about treatment with Protopic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Protopic : EPAR - Summary for the public BG = bălgarski 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public ES = español 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public CS = čeština 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public DA = dansk 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public DE = Deutsch 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public ET = eesti keel 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public EL = elliniká 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public EN = English 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public FR = français 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public IT = italiano 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public LV = latviešu valoda 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public LT = lietuvių kalba 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public HU = magyar 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public MT = Malti 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public NL = Nederlands 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public PL = polski 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public PT = português 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public RO = română 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public SK = slovenčina 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public SL = slovenščina 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public FI = suomi 06/07/2009 16/08/2011
Protopic : EPAR - Summary for the public SV = svenska 06/07/2009 16/08/2011

This EPAR was last updated on 22/01/2016 .

Authorisation details

Product details

Product details for Protopic
NameProtopic
Agency product numberEMEA/H/C/000374
Active substance

tacrolimus

International non-proprietary name (INN) or common name

tacrolimus

Therapeutic area Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code D11AH01

Publication details

Publication details for Protopic
Marketing-authorisation holder

Astellas Pharma Europe B.V.

Revision20
Date of issue of marketing authorisation valid throughout the European Union28/02/2002

Contact address:

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

Product information

16/12/2015  Protopic -EMEA/H/C/000374 -PSUSA/2840/201503

Name Language First published Last updated
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016
Protopic : EPAR - Product Information SV = svenska 06/07/2009 22/01/2016

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.


Name Language First published Last updated
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  
Protopic : EPAR - All Authorised presentations SV = svenska 29/08/2006  

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

Name Language First published Last updated
Protopic : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 06/07/2009 22/01/2016
Protopic-H-C-374-PSUSA-00002840-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 22/01/2016  
Protopic-H-C-374-P45-38 : EPAR - Assessment Report SV = svenska 05/10/2012  
Protopic-H-C-374-II-34 : EPAR - Assessment Report - Variation SV = svenska 06/07/2009  
CHMP post-authorisation summary of positive opinion for Protopic on 22 January 2009 SV = svenska 22/01/2009  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Conclusion SV = svenska 29/08/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
Protopic : EPAR - Procedural steps taken before authorisation SV = svenska 29/08/2006  
Protopic : EPAR - Scientific Discussion SV = svenska 29/08/2006  

Authorised

This medicine is approved for use in the European Union