Levact

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The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levact and associated names. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.

What is Levact?

Levact is an anticancer medicine. It is used to treat the following types of cancer:

  • chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
  • non-Hodgkin’s lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
  • multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).


The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called ‘alkylating agents’. It binds to the DNA of cells while they are reproducing, which stops cell division. As a result, the cancer cells cannot divide and the growth of tumours slows down.
Bendamustine has been used in anticancer medicines in Germany since the early 1970s.

Why was Levact reviewed?

Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).

However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.

The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin’s lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.

What are the conclusions of the CHMP?

The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin’s lymphoma indications. Based on the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Levact outweigh its risks for the two indications for which objections were raised. The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.

Name Language First published Last updated
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) BG = bălgarski 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) ES = español 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) CS = čeština 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) DA = dansk 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) DE = Deutsch 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) ET = eesti keel 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EL = elliniká 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EN = English 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) FR = français 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) IT = italiano 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) LV = latviešu valoda 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) LT = lietuvių kalba 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) HU = magyar 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) MT = Malti 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) NL = Nederlands 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) PL = polski 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) PT = português 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) RO = română 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SK = slovenčina 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SL = slovenščina 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) FI = suomi 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SV = svenska 2010-03-19 2011-09-08

Key facts

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

bendamustine

Associated namesRibomustin
Class
Reference numberEMEA/H/A-29/1238
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date18/03/2010

All documents

Name Language First published Last updated
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) BG = bălgarski 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) ES = español 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) CS = čeština 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) DA = dansk 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) DE = Deutsch 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) ET = eesti keel 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EL = elliniká 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EN = English 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) FR = français 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) IT = italiano 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) LV = latviešu valoda 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) LT = lietuvių kalba 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) HU = magyar 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) MT = Malti 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) NL = Nederlands 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) PL = polski 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) PT = português 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) RO = română 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SK = slovenčina 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SL = slovenščina 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) FI = suomi 2010-03-19 2011-09-08
Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) SV = svenska 2010-03-19 2011-09-08
Levact - Article 29 referral - Annex I, II, III, IV BG = bălgarski 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV ES = español 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV CS = čeština 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV DA = dansk 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV DE = Deutsch 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV ET = eesti keel 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV EL = elliniká 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV EN = English 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV FR = français 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV IT = italiano 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV LV = latviešu valoda 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV LT = lietuvių kalba 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV HU = magyar 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV MT = Malti 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV NL = Nederlands 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV PL = polski 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV PT = português 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV RO = română 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV SK = slovenčina 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV SL = slovenščina 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV FI = suomi 2011-09-08  
Levact - Article 29 referral - Annex I, II, III, IV SV = svenska 2011-09-08  

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