Femara

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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.

Name Language First published Last updated
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) BG = bălgarski 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) ES = español 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) CS = čeština 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) DA = dansk 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) DE = Deutsch 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) ET = eesti keel 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EL = elliniká 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EN = English 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) FR = français 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) IT = italiano 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) LV = latviešu valoda 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) LT = lietuvių kalba 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) HU = magyar 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) MT = Malti 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) NL = Nederlands 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) PL = polski 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) PT = português 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) RO = română 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SK = slovenčina 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SL = slovenščina 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) FI = suomi 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SV = svenska 16/03/2012 12/06/2012

Key facts

Approved nameFemara
International non-proprietary name (INN) or common name

letrozole

Associated namesFemar, Fémara, Loxifan
Class
Reference numberEMEA/H/A-30/1264
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date15/03/2012

All documents

Name Language First published Last updated
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) BG = bălgarski 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) ES = español 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) CS = čeština 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) DA = dansk 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) DE = Deutsch 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) ET = eesti keel 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EL = elliniká 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EN = English 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) FR = français 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) IT = italiano 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) LV = latviešu valoda 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) LT = lietuvių kalba 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) HU = magyar 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) MT = Malti 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) NL = Nederlands 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) PL = polski 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) PT = português 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) RO = română 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SK = slovenčina 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SL = slovenščina 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) FI = suomi 16/03/2012 12/06/2012
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) SV = svenska 16/03/2012 12/06/2012
Femara - Article 30 referral - Assessment Report (English only) 12/06/2012  
Femara - Article 30 referral - Annex I BG = bălgarski 12/06/2012  
Femara - Article 30 referral - Annex I ES = español 12/06/2012  
Femara - Article 30 referral - Annex I CS = čeština 12/06/2012  
Femara - Article 30 referral - Annex I DA = dansk 12/06/2012  
Femara - Article 30 referral - Annex I DE = Deutsch 12/06/2012  
Femara - Article 30 referral - Annex I ET = eesti keel 12/06/2012  
Femara - Article 30 referral - Annex I EL = elliniká 12/06/2012  
Femara - Article 30 referral - Annex I EN = English 12/06/2012  
Femara - Article 30 referral - Annex I FR = français 12/06/2012  
Femara - Article 30 referral - Annex I IT = italiano 12/06/2012  
Femara - Article 30 referral - Annex I LV = latviešu valoda 12/06/2012  
Femara - Article 30 referral - Annex I LT = lietuvių kalba 12/06/2012  
Femara - Article 30 referral - Annex I HU = magyar 12/06/2012  
Femara - Article 30 referral - Annex I MT = Malti 12/06/2012  
Femara - Article 30 referral - Annex I NL = Nederlands 12/06/2012  
Femara - Article 30 referral - Annex I PL = polski 12/06/2012  
Femara - Article 30 referral - Annex I PT = português 12/06/2012  
Femara - Article 30 referral - Annex I RO = română 12/06/2012  
Femara - Article 30 referral - Annex I SK = slovenčina 12/06/2012  
Femara - Article 30 referral - Annex I SL = slovenščina 12/06/2012  
Femara - Article 30 referral - Annex I FI = suomi 12/06/2012  
Femara - Article 30 referral - Annex I SV = svenska 12/06/2012  
Femara - Article 30 referral - Annex I IS = Islenska 12/06/2012  
Femara - Article 30 referral - Annex I NO = Norsk 12/06/2012  
Femara - Article 30 referral - Annex II BG = bălgarski 12/06/2012  
Femara - Article 30 referral - Annex II ES = español 12/06/2012  
Femara - Article 30 referral - Annex II CS = čeština 12/06/2012  
Femara - Article 30 referral - Annex II DA = dansk 12/06/2012  
Femara - Article 30 referral - Annex II DE = Deutsch 12/06/2012  
Femara - Article 30 referral - Annex II ET = eesti keel 12/06/2012  
Femara - Article 30 referral - Annex II EL = elliniká 12/06/2012  
Femara - Article 30 referral - Annex II EN = English 12/06/2012  
Femara - Article 30 referral - Annex II FR = français 12/06/2012  
Femara - Article 30 referral - Annex II IT = italiano 12/06/2012  
Femara - Article 30 referral - Annex II LV = latviešu valoda 12/06/2012  
Femara - Article 30 referral - Annex II LT = lietuvių kalba 12/06/2012  
Femara - Article 30 referral - Annex II HU = magyar 12/06/2012  
Femara - Article 30 referral - Annex II MT = Malti 12/06/2012  
Femara - Article 30 referral - Annex II NL = Nederlands 12/06/2012  
Femara - Article 30 referral - Annex II PL = polski 12/06/2012  
Femara - Article 30 referral - Annex II PT = português 12/06/2012  
Femara - Article 30 referral - Annex II RO = română 12/06/2012  
Femara - Article 30 referral - Annex II SK = slovenčina 12/06/2012  
Femara - Article 30 referral - Annex II SL = slovenščina 12/06/2012  
Femara - Article 30 referral - Annex II FI = suomi 12/06/2012  
Femara - Article 30 referral - Annex II SV = svenska 12/06/2012  
Femara - Article 30 referral - Annex III BG = bălgarski 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III ES = español 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III CS = čeština 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III DA = dansk 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III DE = Deutsch 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III ET = eesti keel 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III EL = elliniká 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III EN = English 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III FR = français 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III IT = italiano 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III LV = latviešu valoda 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III LT = lietuvių kalba 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III HU = magyar 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III MT = Malti 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III NL = Nederlands 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III PL = polski 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III PT = português 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III RO = română 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III SK = slovenčina 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III SL = slovenščina 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III FI = suomi 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III SV = svenska 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III IS = Islenska 16/03/2012 12/06/2012
Femara - Article 30 referral - Annex III NO = Norsk 16/03/2012 12/06/2012

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on Femara