Zyclara

imiquimod

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This is a summary of the European public assessment report (EPAR) for Zyclara. 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 Zyclara.

What is Zyclara?

Zyclara is a cream containing the active substance imiquimod. It is available as 250 mg sachets, each containing 9.375 mg imiquimod (3.75%).

Zyclara is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Zyclara is available in a different strength. The reference medicine for Zyclara is Aldara, which contains imiquimod at 5% strength.

What is Zyclara used for?

Zyclara is used to treat actinic keratosis on the face and balding parts of the scalp. Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight. Zyclara is used to treat adults whose immune system (the body’s natural defences) is working normally when other skin treatments for actinic keratosis cannot be used or are less appropriate.
The medicine can only be obtained with a prescription.

How is Zyclara used?

Zyclara cream is applied in a thin layer to the affected areas of the face or balding scalp once a day before bedtime. The cream should remain on the skin overnight (for about eight hours) before being washed off. Treatment with daily application should continue for two weeks. This is followed by a two-week break without treatment and then a further two weeks of treatment. For further information, see the package leaflet.

The patient’s response to treatment should be evaluated eight weeks after the end of treatment.

How does Zyclara work?

The active substance in Zyclara cream, imiquimod, is an immune-response modifier. This means that it uses the immune system to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon. These substances help to kill abnormal cells in the skin that can lead to keratosis.

How has Zyclara been studied?

Zyclara has been investigated in two main studies involving 479 patients with actinic keratosis on the face and scalp. Two doses of Zyclara (2.5% and 3.75%) were compared with placebo (a dummy treatment) in these studies and the main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis after treatment.

What benefit has Zyclara shown during the studies?

Zyclara was shown to be effective in clearing actinic keratosis from the skin. Around 36% of patients treated with Zyclara 3.75% cream in the two studies had complete clearance compared with around 6% of patients treated with placebo. Zyclara at a lower strength (2.5%) had a lower clearance rate than the 3.75% strength.

What is the risk associated with Zyclara?

Most patients using Zyclara experience local skin side effects (most commonly redness, scab formation, dryness and shedding of the skin). About 11% of patients in studies with Zyclara required treatment to be interrupted due to local side effects. Some other side effects, including headache and tiredness, were also reported. For the full list of all side effects reported with Zyclara, see the package leaflet.

Zyclara must not be used in people who are hypersensitive (allergic) to imiquimod or any of the other ingredients.

Why has Zyclara been approved?

The CHMP concluded that Zyclara 3.75% cream had been shown to be effective at clearing actinic keratosis from the skin and that its use did not raise significant safety concerns. Treatment with Zyclara has the advantage of being easier to adhere to than Aldara treatment because it has a simpler dosing regimen. In addition, its lower strength allows it to be used across larger areas of the skin and thereby treat more of the affected skin.

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

Other information about Zyclara

The European Commission granted a marketing authorisation valid throughout the European Union for Zyclara on 23 August 2012.

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

Name Language First published Last updated
Zyclara : EPAR - Summary for the public BG = bălgarski 13/09/2012  
Zyclara : EPAR - Summary for the public ES = español 13/09/2012  
Zyclara : EPAR - Summary for the public CS = čeština 13/09/2012  
Zyclara : EPAR - Summary for the public DA = dansk 13/09/2012  
Zyclara : EPAR - Summary for the public DE = Deutsch 13/09/2012  
Zyclara : EPAR - Summary for the public ET = eesti keel 13/09/2012  
Zyclara : EPAR - Summary for the public EL = elliniká 13/09/2012  
Zyclara : EPAR - Summary for the public EN = English 13/09/2012  
Zyclara : EPAR - Summary for the public FR = français 13/09/2012  
Zyclara : EPAR - Summary for the public IT = italiano 13/09/2012  
Zyclara : EPAR - Summary for the public LV = latviešu valoda 13/09/2012  
Zyclara : EPAR - Summary for the public LT = lietuvių kalba 13/09/2012  
Zyclara : EPAR - Summary for the public HU = magyar 13/09/2012  
Zyclara : EPAR - Summary for the public MT = Malti 13/09/2012  
Zyclara : EPAR - Summary for the public NL = Nederlands 13/09/2012  
Zyclara : EPAR - Summary for the public PL = polski 13/09/2012  
Zyclara : EPAR - Summary for the public PT = português 13/09/2012  
Zyclara : EPAR - Summary for the public RO = română 13/09/2012  
Zyclara : EPAR - Summary for the public SK = slovenčina 13/09/2012  
Zyclara : EPAR - Summary for the public SL = slovenščina 13/09/2012  
Zyclara : EPAR - Summary for the public FI = suomi 13/09/2012  
Zyclara : EPAR - Summary for the public SV = svenska 13/09/2012  

This EPAR was last updated on 28/11/2013 .

Authorisation details

Product details

Product details for Zyclara
NameZyclara
Agency product numberEMEA/H/C/002387
Active substance

imiquimod

International non-proprietary name (INN) or common name

imiquimod

Therapeutic area Keratosis
Anatomical therapeutic chemical (ATC) code D06BB10

Publication details

Publication details for Zyclara
Marketing-authorisation holder

Meda AB

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/08/2012

Contact address:

Meda AB
Pipers väg 2A
SE-170 09 Solna
Sweden

Product information

Product information

26/09/2013  Zyclara -EMEA/H/C/002387 -N/5

Name Language First published Last updated
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013
Zyclara : EPAR - Product Information SV = svenska 13/09/2012 28/11/2013

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
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  
Zyclara : EPAR - All Authorised presentations SV = svenska 13/09/2012  

Pharmacotherapeutic group

Antibiotics and chemotherapeutics for dermatological use

Therapeutic indication

Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zyclara : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 28/11/2013  

Initial marketing-authorisation documents

Name Language First published Last updated
Zyclara : EPAR - Public assessment report SV = svenska 13/09/2012  
CHMP summary of positive opinion for Zyclara SV = svenska 22/06/2012  

Authorised

This medicine is approved for use in the European Union

More information on Zyclara