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Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules)

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

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

What is Vepesid?

Vepesid is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer and cancers of the blood (Hodgkin’s and non-Hodgkin’s lymphoma and acute myeloid leukaemia).

Vepesid contains the active substance etoposide and is available as capsules to be taken by mouth.

Vepesid is marketed in 16 EU member States (Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Romania, Slovenia, Spain, Sweden and the United Kingdom) as well as in Norway. It is also available in the EU under the trade name Vepesid K.

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

Why was Vepesid reviewed?

Vepesid 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.

Vepesid 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 Vepesid 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 Vepesid should be used in combination with other cancer treatments to treat the following cancers in adults:

  • testicular cancer that is resistant to treatment or has come back;
  • small-cell lung cancer;
  • Hodgkin’s lymphoma as second-line treatment;
  • non-Hodgkin’s lymphoma that is resistant to treatment or has come back;
  • acute myeloid leukaemia that is resistant to treatment or has come back;
  • non-epithelial ovarian cancer.

In addition, the CHMP recommended Vepesid 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.

4.2 Posology and method of administration

The dose of Vepesid is based on the recommended dose for the intravenous etoposide medicines, with a 100 mg oral dose being comparable to a 75 mg intravenous one.

The usual dose of Vepesid is 100 to 200 mg per m2of body surface area for 5 days in a row or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.

Vepesid capsules should be taken on an empty stomach.

4.3 Contra-indications

Vepesid should not be taken at the same time as vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be taken by 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
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) BG = bălgarski 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) ES = español 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) CS = čeština 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) DA = dansk 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) DE = Deutsch 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) ET = eesti keel 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) EL = elliniká 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) EN = English 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) FR = français 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) IT = italiano 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) LV = latviešu valoda 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) LT = lietuvių kalba 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) HU = magyar 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) MT = Malti 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) NL = Nederlands 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) PL = polski 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) PT = português 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) RO = română 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SK = slovenčina 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SL = slovenščina 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) FI = suomi 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SV = svenska 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) HR = Hrvatski 2017-04-21 2017-07-14

Key facts

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

etoposide

Associated names
Class
Reference numberEMEA/H/A-30/1425
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
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) BG = bălgarski 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) ES = español 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) CS = čeština 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) DA = dansk 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) DE = Deutsch 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) ET = eesti keel 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) EL = elliniká 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) EN = English 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) FR = français 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) IT = italiano 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) LV = latviešu valoda 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) LT = lietuvių kalba 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) HU = magyar 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) MT = Malti 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) NL = Nederlands 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) PL = polski 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) PT = português 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) RO = română 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SK = slovenčina 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SL = slovenščina 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) FI = suomi 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) SV = svenska 2017-04-21 2017-07-14
Questions and answers on Vepesid and associated names (etoposide, 50 and 100 mg capsules) HR = Hrvatski 2017-04-21 2017-07-14
Vepesid Article-30 referral - CHMP assessment Report (English only) 2017-07-14  
Vepesid Article-30 referral - Annex I BG = bălgarski 2017-07-14  
Vepesid Article-30 referral - Annex I ES = español 2017-07-14  
Vepesid Article-30 referral - Annex I CS = čeština 2017-07-14  
Vepesid Article-30 referral - Annex I DA = dansk 2017-07-14  
Vepesid Article-30 referral - Annex I DE = Deutsch 2017-07-14  
Vepesid Article-30 referral - Annex I ET = eesti keel 2017-07-14  
Vepesid Article-30 referral - Annex I EL = elliniká 2017-07-14  
Vepesid Article-30 referral - Annex I EN = English 2017-07-14  
Vepesid Article-30 referral - Annex I FR = français 2017-07-14  
Vepesid Article-30 referral - Annex I IT = italiano 2017-07-14  
Vepesid Article-30 referral - Annex I LV = latviešu valoda 2017-07-14  
Vepesid Article-30 referral - Annex I LT = lietuvių kalba 2017-07-14  
Vepesid Article-30 referral - Annex I HU = magyar 2017-07-14  
Vepesid Article-30 referral - Annex I MT = Malti 2017-07-14  
Vepesid Article-30 referral - Annex I NL = Nederlands 2017-07-14  
Vepesid Article-30 referral - Annex I PL = polski 2017-07-14  
Vepesid Article-30 referral - Annex I PT = português 2017-07-14  
Vepesid Article-30 referral - Annex I RO = română 2017-07-14  
Vepesid Article-30 referral - Annex I SK = slovenčina 2017-07-14  
Vepesid Article-30 referral - Annex I SL = slovenščina 2017-07-14  
Vepesid Article-30 referral - Annex I FI = suomi 2017-07-14  
Vepesid Article-30 referral - Annex I SV = svenska 2017-07-14  
Vepesid Article-30 referral - Annex I HR = Hrvatski 2017-07-14  
Vepesid Article-30 referral - Annex I NO = Norsk 2017-07-14  
Vepesid Article-30 referral - Annex II BG = bălgarski 2017-07-14  
Vepesid Article-30 referral - Annex II ES = español 2017-07-14  
Vepesid Article-30 referral - Annex II CS = čeština 2017-07-14  
Vepesid Article-30 referral - Annex II DA = dansk 2017-07-14  
Vepesid Article-30 referral - Annex II DE = Deutsch 2017-07-14  
Vepesid Article-30 referral - Annex II ET = eesti keel 2017-07-14  
Vepesid Article-30 referral - Annex II EL = elliniká 2017-07-14  
Vepesid Article-30 referral - Annex II EN = English 2017-07-14  
Vepesid Article-30 referral - Annex II FR = français 2017-07-14  
Vepesid Article-30 referral - Annex II IT = italiano 2017-07-14  
Vepesid Article-30 referral - Annex II LV = latviešu valoda 2017-07-14  
Vepesid Article-30 referral - Annex II LT = lietuvių kalba 2017-07-14  
Vepesid Article-30 referral - Annex II HU = magyar 2017-07-14  
Vepesid Article-30 referral - Annex II MT = Malti 2017-07-14  
Vepesid Article-30 referral - Annex II NL = Nederlands 2017-07-14  
Vepesid Article-30 referral - Annex II PL = polski 2017-07-14  
Vepesid Article-30 referral - Annex II PT = português 2017-07-14  
Vepesid Article-30 referral - Annex II RO = română 2017-07-14  
Vepesid Article-30 referral - Annex II SK = slovenčina 2017-07-14  
Vepesid Article-30 referral - Annex II SL = slovenščina 2017-07-14  
Vepesid Article-30 referral - Annex II FI = suomi 2017-07-14  
Vepesid Article-30 referral - Annex II SV = svenska 2017-07-14  
Vepesid Article-30 referral - Annex II HR = Hrvatski 2017-07-14  
Vepesid Article-30 referral - Annex III BG = bălgarski 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III ES = español 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III CS = čeština 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III DA = dansk 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III DE = Deutsch 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III ET = eesti keel 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III EL = elliniká 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III EN = English 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III FR = français 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III IT = italiano 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III LV = latviešu valoda 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III LT = lietuvių kalba 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III HU = magyar 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III MT = Malti 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III NL = Nederlands 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III PL = polski 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III PT = português 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III RO = română 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III SK = slovenčina 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III SL = slovenščina 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III FI = suomi 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III SV = svenska 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III HR = Hrvatski 2017-04-21 2017-07-14
Vepesid Article-30 referral - Annex III NO = Norsk 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

More information on Vepesid