Daivobet - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Daivobet. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Daivobet in the European Union (EU).

What is Daivobet?

Daivobet is used to treat adults with psoriasis (a disease causing red, scaly patches on the skin). It is available as a gel and ointment and is used topically (applied on the skin).

Daivobet contains two active substances: calcipotriol and betamethasone. Calcipotriol, a substance derived from vitamin D, acts through receptors in the skin to prevent the multiplication of cells that cause the scaly patches in psoriasis. Betamethasone is an anti-inflammatory medicine that helps to reduce the inflammation and itching that occur with psoriasis.

Daivobet is also available in the EU under the trade name Dovobet. The company that markets these medicines is Leo Pharmaceutical Products.

Why was Daivobet reviewed?

Daivobet ointment was authorised in some Member States through a mutual recognition procedure and in others through national procedures. Daivobet gel was authorised via a decentralised procedure. Because of this, there are some differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.

On 10 March 2010, Leo Pharmaceutical Products referred Daivobet to the CHMP in order to harmonise the marketing authorisations for the product in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Daivobet ointment is to be used for the treatment of adults with plaque psoriasis where it is possible to use a topical medicine. Daivobet gel is for the treatment of psoriasis on the scalp or mild to moderate plaque psoriasis on other parts of the body.

4.2 Posology and method of administration

Daivobet should be applied once a day on the affected areas of the skin. No more than 15 g of the gel or ointment should be used in one day. The recommended treatment period for the ointment is four weeks. For the gel, the recommended treatment period is four weeks for scalp psoriasis and eight weeks for non-scalp psoriasis. Further treatment can be given under medical supervision.

4.3 Contra-indications

Daivobet should not be used in patients who may be hypersensitive (allergic) to the active substances or to any other ingredient. Daivobet must not be used in patients who have some types of psoriasis that is red and flaking off or filled with pus. It must also not be used in patients with abnormal levels of calcium in their blood.

The Committee also harmonised a list of contra-indications related to skin conditions, including viral lesions of the skin, fungal or bacterial skin infections, parasitic infections and skin problems caused by tuberculosis or syphilis. For the full list, see the harmonised SmPC.

Other changes

The Committee also harmonised other sections of the SmPC, including the sections on special warnings, pregnancy and lactation and undesirable effects.

The amended information to doctors and patients is available in the 'All documents' tab.

The European Commission issued a decision on 30 September 2010.

Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g)

Adopted

Key facts

About this medicine

• Approved name:
  Daivobet
• International non-proprietary name (INN) or common name:
  • calcipotriol
  • betamethasone
• Associated names:
  Dovobet

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001266
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  22/07/2010
• EC decision date:
  30/09/2010

All documents

Daivobet - Article 30 referral - Annexes I, II, III

Questions and answers on Daivobet and associated names (calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 mg per g)

Adopted

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.