Vepesid - referral

Current status

European Commission final decision

Overview

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).

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

Reference Number: EMEA/H/A-30/1425 Summary:

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).

Key facts

About this medicine

• Approved name:
  Vepesid
• International non-proprietary name (INN) or common name:
  etoposide

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1425
• Type:
  Article 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 EU.

Key dates and outcomes

• CHMP opinion date:
  21/04/2017
• EC decision date:
  26/06/2017

All documents

Opinion provided by Committee for Medicinal Products for human Use

Vepesid Article-30 referral - Annex III

Reference Number: EMEA/H/A-30/1425

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

Reference Number: EMEA/H/A-30/1425 Summary:

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).

European Commission final decision

Vepesid Article-30 referral - CHMP assessment Report

Reference Number: EMA/409248/2017

Vepesid Article-30 referral - Annex I

Vepesid Article-30 referral - Annex II

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.