Etopophos

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Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion)

Outcome of a procedure under Article 30 of Directive 2001/83/EC

On 21 April 2017, the European Medicines Agency completed a review of Etopophos. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).

What is Etopophos?

Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin’s and non-Hodgkin’s lymphoma and acute myeloid leukaemia). 

Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.

Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom. It is also available in the EU under the trade name Etopofos.

The company that markets these medicines is Bristol-Myers Squibb.

Why was Etopophos reviewed?

Etopophos 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.

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

On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos 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 and package leaflets should be harmonised across the EU.

The areas of the SmPC harmonised include:

4.1 Therapeutic indications

The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:

  • testicular cancer, including cancer that is resistant to treatment or has come back;
  • small-cell lung cancer;
  • Hodgkin’s and non-Hodgkin’s lymphoma;
  • acute myeloid leukaemia;
  • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
  • non-epithelial ovarian cancer.

In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.

For blood cancers (Hodgkin’s and non-Hodgkin’s lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.

4.2 Posology and method of administration

Etopophos is given as a slow intravenous infusion. The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5. The course of treatment may be repeated but not sooner than 21 days after the start of the first course.

4.3 Contra-indications

Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.

Other changes

Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).

Name Language First published Last updated
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) BG = bălgarski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) ES = español 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) CS = čeština 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) DA = dansk 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) DE = Deutsch 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) ET = eesti keel 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) EL = elliniká 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) EN = English 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) FR = français 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) IT = italiano 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) LV = latviešu valoda 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) LT = lietuvių kalba 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) HU = magyar 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) MT = Malti 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) NL = Nederlands 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) PL = polski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) PT = português 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) RO = română 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SK = slovenčina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SL = slovenščina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) FI = suomi 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SV = svenska 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) HR = Hrvatski 2017-04-21 2017-07-14

Key facts

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

etoposide phosphate

Associated names
Class
Reference numberEMEA/H/A-30/1417
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 date21/04/2017

All documents

Name Language First published Last updated
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) BG = bălgarski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) ES = español 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) CS = čeština 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) DA = dansk 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) DE = Deutsch 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) ET = eesti keel 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) EL = elliniká 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) EN = English 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) FR = français 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) IT = italiano 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) LV = latviešu valoda 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) LT = lietuvių kalba 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) HU = magyar 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) MT = Malti 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) NL = Nederlands 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) PL = polski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) PT = português 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) RO = română 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SK = slovenčina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SL = slovenščina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) FI = suomi 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) SV = svenska 2017-04-21 2017-07-14
Etopophos Article-30 referral - Questions and answers on Etopophos and associated names (etoposide, 100 and 1000 mg powder for solution for infusion) HR = Hrvatski 2017-04-21 2017-07-14
Etopophos Article-30 referral - CHMP assessment report (English only) 2017-07-14  
Etopophos Article-30 referral - Annex I BG = bălgarski 2017-07-14  
Etopophos Article-30 referral - Annex I ES = español 2017-07-14  
Etopophos Article-30 referral - Annex I CS = čeština 2017-07-14  
Etopophos Article-30 referral - Annex I DA = dansk 2017-07-14  
Etopophos Article-30 referral - Annex I DE = Deutsch 2017-07-14  
Etopophos Article-30 referral - Annex I ET = eesti keel 2017-07-14  
Etopophos Article-30 referral - Annex I EL = elliniká 2017-07-14  
Etopophos Article-30 referral - Annex I EN = English 2017-07-14  
Etopophos Article-30 referral - Annex I FR = français 2017-07-14  
Etopophos Article-30 referral - Annex I IT = italiano 2017-07-14  
Etopophos Article-30 referral - Annex I LV = latviešu valoda 2017-07-14  
Etopophos Article-30 referral - Annex I LT = lietuvių kalba 2017-07-14  
Etopophos Article-30 referral - Annex I HU = magyar 2017-07-14  
Etopophos Article-30 referral - Annex I MT = Malti 2017-07-14  
Etopophos Article-30 referral - Annex I NL = Nederlands 2017-07-14  
Etopophos Article-30 referral - Annex I PL = polski 2017-07-14  
Etopophos Article-30 referral - Annex I PT = português 2017-07-14  
Etopophos Article-30 referral - Annex I RO = română 2017-07-14  
Etopophos Article-30 referral - Annex I SK = slovenčina 2017-07-14  
Etopophos Article-30 referral - Annex I SL = slovenščina 2017-07-14  
Etopophos Article-30 referral - Annex I FI = suomi 2017-07-14  
Etopophos Article-30 referral - Annex I SV = svenska 2017-07-14  
Etopophos Article-30 referral - Annex I HR = Hrvatski 2017-07-14  
Etopophos Article-30 referral - Annex II BG = bălgarski 2017-07-14  
Etopophos Article-30 referral - Annex II ES = español 2017-07-14  
Etopophos Article-30 referral - Annex II CS = čeština 2017-07-14  
Etopophos Article-30 referral - Annex II DA = dansk 2017-07-14  
Etopophos Article-30 referral - Annex II DE = Deutsch 2017-07-14  
Etopophos Article-30 referral - Annex II ET = eesti keel 2017-07-14  
Etopophos Article-30 referral - Annex II EL = elliniká 2017-07-14  
Etopophos Article-30 referral - Annex II EN = English 2017-07-14  
Etopophos Article-30 referral - Annex II FR = français 2017-07-14  
Etopophos Article-30 referral - Annex II IT = italiano 2017-07-14  
Etopophos Article-30 referral - Annex II LV = latviešu valoda 2017-07-14  
Etopophos Article-30 referral - Annex II LT = lietuvių kalba 2017-07-14  
Etopophos Article-30 referral - Annex II HU = magyar 2017-07-14  
Etopophos Article-30 referral - Annex II MT = Malti 2017-07-14  
Etopophos Article-30 referral - Annex II NL = Nederlands 2017-07-14  
Etopophos Article-30 referral - Annex II PL = polski 2017-07-14  
Etopophos Article-30 referral - Annex II PT = português 2017-07-14  
Etopophos Article-30 referral - Annex II RO = română 2017-07-14  
Etopophos Article-30 referral - Annex II SK = slovenčina 2017-07-14  
Etopophos Article-30 referral - Annex II SL = slovenščina 2017-07-14  
Etopophos Article-30 referral - Annex II FI = suomi 2017-07-14  
Etopophos Article-30 referral - Annex II SV = svenska 2017-07-14  
Etopophos Article-30 referral - Annex II HR = Hrvatski 2017-07-14  
Etopophos Article-30 referral - Annex III BG = bălgarski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III ES = español 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III CS = čeština 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III DA = dansk 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III DE = Deutsch 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III ET = eesti keel 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III EL = elliniká 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III EN = English 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III FR = français 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III IT = italiano 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III LV = latviešu valoda 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III LT = lietuvių kalba 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III HU = magyar 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III MT = Malti 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III NL = Nederlands 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III PL = polski 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III PT = português 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III RO = română 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III SK = slovenčina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III SL = slovenščina 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III FI = suomi 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III SV = svenska 2017-04-21 2017-07-14
Etopophos Article-30 referral - Annex III HR = Hrvatski 2017-04-21 2017-07-14

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

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