Kytril
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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).
Key facts
Approved name |
Kytril
|
International non-proprietary name (INN) or common name |
granisetron |
Associated names |
Kevatril
|
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. |
Status |
European Commission final decision
|
Opinion date |
19/05/2011
|
EC decision date |
20/07/2011
|
All documents
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List item
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) (PDF/97.92 KB)
First published: 20/05/2011
Last updated: 12/09/2011
EMA/217176/2011 -
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Kytril - Article 30 referral - Annex I (PDF/392.79 KB)
Adopted
First published: 12/09/2011
Last updated: 12/09/2011 -
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List item
Kytril - Article 30 referral - Annex II (PDF/99.03 KB)
Adopted
First published: 12/09/2011
Last updated: 12/09/2011 -
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List item
Kytril - Article 30 referral - Annex III (PDF/540.4 KB)
Adopted
First published: 12/09/2011
Last updated: 12/09/2011 -
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List item
Assessment report pursuant to Article 30 of Directive 2001/83/EC - Kytril and associated names (PDF/308.31 KB)
Adopted
First published: 12/09/2011
Last updated: 12/09/2011
EMA/708931/2011
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 havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies