Novantrone and associated names

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On 28 April 2016, the European Medicines Agency completed a review of Novantrone. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Novantrone in the European Union (EU).

What is Novantrone?

Novantrone is a medicine that is used in the treatment of cancers including breast cancer, non-Hodgkin’s lymphoma (a cancer of the lymphatic system, which is part of the immune system) and certain types of blood cancer, as well as pain caused by prostate cancer. It is also used to treat patients with worsening multiple sclerosis when no alternative treatments are available.

Novantrone contains the active substance mitoxantrone and it is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Novantrone is marketed in the following EU member states: Cyprus, Finland, France, Germany, Greece, Italy, Romania, Slovenia, Spain and Sweden, as well as Iceland and Norway. It is also available in the EU under the trade names Elsep and Ralenova.

The company that markets these medicines is MEDA.

Why was Novantrone reviewed?

Novantrone has been authorised in the EU via national procedures. This has led to divergences across Member States in the medicine’s authorised uses, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets.

Novantrone was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 1 October 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Novantrone 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, considered 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 Novantrone can be used for the treatment of the following conditions:

  • Metastatic breast cancer (breast cancer that has spread to other parts of the body);
  • Non-Hodgkin’s lymphoma;
  • Acute myeloid leukaemia (cancer of a type of white blood cell called myeloid cells);
  • ‘Blast crisis’ in chronic myeloid leukaemia (the final, rapidly progressive stage of another type of cancer of white blood cells);
  • Relief of pain in patients with advanced prostate cancer;
  • Highly active relapsing multiple sclerosis associated with rapidly evolving disability, in patients for whom no alternative treatments are available.

The CHMP also agreed that Novantrone should no longer be approved for the treatment of acute lymphocytic leukaemia (a cancer of a different type of white blood cells) and liver cancer.

4.2 Posology and method of administration

The CHMP also harmonised the recommendations on how to use Novantrone for the different indications. The recommended dose of Novantrone and the duration of treatment depend on the disease it is used for, whether it is used in combination with other medicines, on the height and weight of the patient, and on the response to treatment. Daily doses vary from 6 to 14 mg per square metre of body surface area (calculated using the patient's height and weight). Novantrone should only be given by infusion into a vein.

4.3 Contra-indications

Mitoxantrone, the active substance in Novantrone, passes into breast milk and has been detected in breast milk for up to one month after the medicine was discontinued. Therefore, to avoid potential serious side effects in breastfed infants, breastfeeding must be discontinued before starting treatment with Novantrone.

Additionally, Novantrone must not be used for the treatment of multiple sclerosis in pregnant women.

Other changes

The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects) and 5.1 (pharmacodynamic properties).

A risk management plan will be developed to ensure that Novantrone is used as safely as possible. As part of this plan, the company will provide educational materials about the use of Novantrone in patients with multiple sclerosis. The educational materials will include a guide and checklist for healthcare professionals informing of the risks of cardiotoxicity (harm to the heart) and leukaemia with the medicine, and how patients should be monitored. Patients will receive a guide to the risks and an alert card describing the signs and symptoms to watch out for. The company will prepare a survey for healthcare professionals to check how well these materials work.

The amended information to doctors and patients is available in Annex III under 'All Documents' tab.

A European Commission decision on this opinion will be issued in due course.

Name Language First published Last updated
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) BG = bălgarski 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) ES = español 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) CS = čeština 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) DA = dansk 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) DE = Deutsch 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) ET = eesti keel 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) EL = elliniká 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) EN = English 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) FR = français 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) IT = italiano 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) LV = latviešu valoda 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) LT = lietuvių kalba 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) HU = magyar 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) MT = Malti 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) NL = Nederlands 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) PL = polski 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) PT = português 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) RO = română 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SK = slovenčina 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SL = slovenščina 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) FI = suomi 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SV = svenska 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) HR = Hrvatski 2016-04-29  

Key facts

Approved nameNovantrone and associated names
International non-proprietary name (INN) or common name

mitoxantrone

Associated namesElsep, Ralenova
ClassAntineoplastic agent
Reference numberEMEA/H/A-30/1399
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 date28/04/2016

All documents

Name Language First published Last updated
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) BG = bălgarski 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) ES = español 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) CS = čeština 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) DA = dansk 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) DE = Deutsch 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) ET = eesti keel 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) EL = elliniká 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) EN = English 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) FR = français 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) IT = italiano 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) LV = latviešu valoda 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) LT = lietuvių kalba 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) HU = magyar 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) MT = Malti 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) NL = Nederlands 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) PL = polski 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) PT = português 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) RO = română 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SK = slovenčina 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SL = slovenščina 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) FI = suomi 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) SV = svenska 2016-04-29  
Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion) HR = Hrvatski 2016-04-29  
Novantrone and associated names Article-30 referral - Assessment report (English only) 2016-07-05  
Novantrone Article-30 referral - Annex I BG = bălgarski 2016-07-05  
Novantrone Article-30 referral - Annex I ES = español 2016-07-05  
Novantrone Article-30 referral - Annex I CS = čeština 2016-07-05  
Novantrone Article-30 referral - Annex I DA = dansk 2016-07-05  
Novantrone Article-30 referral - Annex I DE = Deutsch 2016-07-05  
Novantrone Article-30 referral - Annex I ET = eesti keel 2016-07-05  
Novantrone Article-30 referral - Annex I EL = elliniká 2016-07-05  
Novantrone Article-30 referral - Annex I EN = English 2016-07-05  
Novantrone Article-30 referral - Annex I FR = français 2016-07-05  
Novantrone Article-30 referral - Annex I IT = italiano 2016-07-05  
Novantrone Article-30 referral - Annex I LV = latviešu valoda 2016-07-05  
Novantrone Article-30 referral - Annex I LT = lietuvių kalba 2016-07-05  
Novantrone Article-30 referral - Annex I HU = magyar 2016-07-05  
Novantrone Article-30 referral - Annex I MT = Malti 2016-07-05  
Novantrone Article-30 referral - Annex I NL = Nederlands 2016-07-05  
Novantrone Article-30 referral - Annex I PL = polski 2016-07-05  
Novantrone Article-30 referral - Annex I PT = português 2016-07-05  
Novantrone Article-30 referral - Annex I RO = română 2016-07-05  
Novantrone Article-30 referral - Annex I SK = slovenčina 2016-07-05  
Novantrone Article-30 referral - Annex I SL = slovenščina 2016-07-05  
Novantrone Article-30 referral - Annex I FI = suomi 2016-07-05  
Novantrone Article-30 referral - Annex I SV = svenska 2016-07-05  
Novantrone Article-30 referral - Annex I HR = Hrvatski 2016-07-05  
Novantrone Article-30 referral - Annex I IS = Islenska 2016-07-05  
Novantrone Article-30 referral - Annex I NO = Norsk 2016-07-05  
Novantrone Article-30 referral - Annex II BG = bălgarski 2016-07-05  
Novantrone Article-30 referral - Annex II ES = español 2016-07-05  
Novantrone Article-30 referral - Annex II CS = čeština 2016-07-05  
Novantrone Article-30 referral - Annex II DA = dansk 2016-07-05  
Novantrone Article-30 referral - Annex II DE = Deutsch 2016-07-05  
Novantrone Article-30 referral - Annex II ET = eesti keel 2016-07-05  
Novantrone Article-30 referral - Annex II EL = elliniká 2016-07-05  
Novantrone Article-30 referral - Annex II EN = English 2016-07-05  
Novantrone Article-30 referral - Annex II FR = français 2016-07-05  
Novantrone Article-30 referral - Annex II IT = italiano 2016-07-05  
Novantrone Article-30 referral - Annex II LV = latviešu valoda 2016-07-05  
Novantrone Article-30 referral - Annex II LT = lietuvių kalba 2016-07-05  
Novantrone Article-30 referral - Annex II HU = magyar 2016-07-05  
Novantrone Article-30 referral - Annex II MT = Malti 2016-07-05  
Novantrone Article-30 referral - Annex II NL = Nederlands 2016-07-05  
Novantrone Article-30 referral - Annex II PL = polski 2016-07-05  
Novantrone Article-30 referral - Annex II PT = português 2016-07-05  
Novantrone Article-30 referral - Annex II RO = română 2016-07-05  
Novantrone Article-30 referral - Annex II SK = slovenčina 2016-07-05  
Novantrone Article-30 referral - Annex II SL = slovenščina 2016-07-05  
Novantrone Article-30 referral - Annex II FI = suomi 2016-07-05  
Novantrone Article-30 referral - Annex II SV = svenska 2016-07-05  
Novantrone Article-30 referral - Annex II HR = Hrvatski 2016-07-05  
Novantrone Article-30 referral - Annex III BG = bălgarski 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III ES = español 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III CS = čeština 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III DA = dansk 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III DE = Deutsch 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III ET = eesti keel 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III EL = elliniká 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III EN = English 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III FR = français 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III IT = italiano 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III LV = latviešu valoda 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III LT = lietuvių kalba 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III HU = magyar 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III MT = Malti 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III NL = Nederlands 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III PL = polski 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III PT = português 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III RO = română 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III SK = slovenčina 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III SL = slovenščina 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III FI = suomi 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III SV = svenska 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III HR = Hrvatski 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III IS = Islenska 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex III NO = Norsk 2016-04-29 2016-07-05
Novantrone Article-30 referral - Annex IV BG = bălgarski 2016-07-05  
Novantrone Article-30 referral - Annex IV ES = español 2016-07-05  
Novantrone Article-30 referral - Annex IV CS = čeština 2016-07-05  
Novantrone Article-30 referral - Annex IV DA = dansk 2016-07-05  
Novantrone Article-30 referral - Annex IV DE = Deutsch 2016-07-05  
Novantrone Article-30 referral - Annex IV ET = eesti keel 2016-07-05  
Novantrone Article-30 referral - Annex IV EL = elliniká 2016-07-05  
Novantrone Article-30 referral - Annex IV EN = English 2016-07-05  
Novantrone Article-30 referral - Annex IV FR = français 2016-07-05  
Novantrone Article-30 referral - Annex IV IT = italiano 2016-07-05  
Novantrone Article-30 referral - Annex IV LV = latviešu valoda 2016-07-05  
Novantrone Article-30 referral - Annex IV LT = lietuvių kalba 2016-07-05  
Novantrone Article-30 referral - Annex IV HU = magyar 2016-07-05  
Novantrone Article-30 referral - Annex IV MT = Malti 2016-07-05  
Novantrone Article-30 referral - Annex IV NL = Nederlands 2016-07-05  
Novantrone Article-30 referral - Annex IV PL = polski 2016-07-05  
Novantrone Article-30 referral - Annex IV PT = português 2016-07-05  
Novantrone Article-30 referral - Annex IV RO = română 2016-07-05  
Novantrone Article-30 referral - Annex IV SK = slovenčina 2016-07-05  
Novantrone Article-30 referral - Annex IV SL = slovenščina 2016-07-05  
Novantrone Article-30 referral - Annex IV FI = suomi 2016-07-05  
Novantrone Article-30 referral - Annex IV SV = svenska 2016-07-05  
Novantrone Article-30 referral - Annex IV HR = Hrvatski 2016-07-05  

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

Related information on Novantrone and associated names