Kytril - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Kytril. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Kytril in the European Union (EU).

What is Kytril?

Kytril is an anti-emetic (a medicine that prevents nausea and vomiting). It is used to prevent nausea and vomiting following treatments for cancer such as chemotherapy and radiotherapy.

The active substance in Kytril, granisetron, is a '5HT₃ antagonist'. This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT₃ receptors in the in the brain and the gut. When 5HT attaches to these receptors, it normally causes nausea and vomiting. Granisetron prevents the nausea and vomiting by blocking these receptors.

Kytril is also available in the EU under the trade name Kevatril. The company that markets these medicines is Roche.

Why was Kytril reviewed?

Kytril 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.

Kytril was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 3 June 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Kytril 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, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP recommended that Kytril tablets and solution for injection can be used in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy, and also for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.

In addition, the solution for injection can be used in adults for the prevention and treatment of nausea and vomiting following surgery.

The solution for injection can also be used in children aged two years above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.

4.2 Posology and method of administration

Kytril tablets should be swallowed whole with water. For the prevention of nausea and vomiting, the recommended dose is 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.

Kytril solution for injection is given into a vein at a dose of 1-3 mg (10-40 ?g/kg) for the prevention and treatment of nausea and vomiting in adults. When used for treatment, further doses of the solution may be given at least 10 minutes apart, up to a maximum of 9 mg per 24 hours.

4.3 Contra-indications

Kytril must not be used in patients who are hypersensitive (allergic) to the active substance or to any of the excipients.

Other changes

Other sections harmonised by the CHMP include sections on special warnings, side effects and the medicine's pharmacological properties.

The amended information to doctors and patients is available under the 'all documents' tab.

The European Commission issued a decision on 20 July 2011.

Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection)

Reference Number: EMA/217176/2011

Key facts

About this medicine

• Approved name:
  Kytril
• International non-proprietary name (INN) or common name:
  granisetron
• Associated names:
  Kevatril

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1155
• 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:
  19/05/2011
• EC decision date:
  20/07/2011

All documents

Kytril - Article 30 referral - Annex I

Adopted

Kytril - Article 30 referral - Annex II

Adopted

Kytril - Article 30 referral - Annex III

Adopted

Assessment report pursuant to Article 30 of Directive 2001/83/EC - Kytril and associated names

AdoptedReference Number: EMA/708931/2011

Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection)

Reference Number: EMA/217176/2011

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.