Femara - referral

Current status

European Commission final decision

Overview

On 15 March 2012, the European Medicines Agency completed a review of Femara. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).

What is Femara?

Femara is a medicine that contains the active substance letrozole. It is used as hormonal treatment in postmenopausal women with breast cancer.

The active substance in Femara, letrozole, is an 'aromatase inhibitor'. This means that it works by blocking the action of an enzyme called 'aromatase', which is involved in the production of the hormone oestrogen. In some types of breast cancer (hormone receptor positive or hormone-dependent types), oestrogen is known to stimulate the growth of the cancer cells. By blocking the activity of aromatase and thereby reducing the amount of oestrogen produced, the medicine slows or stops the growth and spread of the cancer.

Femara is used in postmenopausal women because aromatase is involved in producing most of the oestrogen in this population.

Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan.

The company that markets these medicines is Novartis.

Why was Femara reviewed?

Femara is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Femara was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU.

What are the conclusions of the CHMP?

The CHMP, in 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 main areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the medicine's use, the CHMP agreed that Femara should be used in postmenopausal women for the following:

• Adjuvant (post-surgery) treatment of hormone receptor positive invasive early breast cancer.
• Extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years.
• First-line treatment for hormone-dependent advanced breast cancer.
• Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
• Neo-adjuvant (pre-surgery) treatment of hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function.

4.3 Contra-indications

In harmonising the contraindications, the CHMP decided against including two contraindications that were in the SmPCs of some EU countries: liver impairment and pre-operative use in patients whose receptor status is negative or unknown. The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects).

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

The European Commission issued a decision on 22 May 2012.

Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)

AdoptedReference Number: EMA/180824/2012Summary:

On 15 March 2012, the European Medicines Agency completed a review of Femara. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).

Key facts

About this medicine

• Approved name:
  Femara
• International non-proprietary name (INN) or common name:
  letrozole
• Associated names:
  • Femar
  • Fémara
  • Loxifan

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1264
• 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:
  15/03/2012
• EC decision date:
  22/05/2012

All documents

Femara - Article 30 referral - Assessment Report

AdoptedReference Number: EMA/267448/2012

Femara - Article 30 referral - Annex I

Adopted

Femara - Article 30 referral - Annex II

Adopted

Femara - Article 30 referral - Annex III

Adopted

Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)

AdoptedReference Number: EMA/180824/2012Summary:

On 15 March 2012, the European Medicines Agency completed a review of Femara. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).

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.