Varilrix
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status
European Commission final decision
Overview
Use of Varilrix (live attenuated varicella virus [OKA strain]) to be harmonised in the EU
On 25 February 2021, the European Medicines Agency (EMA) completed a review of Varilrix and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Key facts
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About this medicine
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|---|---|
| Approved name |
Varilrix
|
| International non-proprietary name (INN) or common name |
live attenuated varicella virus (OKA strain)
|
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About this procedure
|
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-30/1499
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| 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. |
| Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
25/02/2021
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| EC decision date |
21/04/2021
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All documents
Procedure started
List item
Varilrix Article 30 referral - Notification (PDF/1.84 MB)
First published: 26/06/2020
List item
Varilrix Article 30 referral - Annex I (PDF/151.61 KB)
First published: 26/06/2020
Last updated: 18/05/2021
List item
Varilrix Article 30 referral - Review started (PDF/106.09 KB)
First published: 26/06/2020
EMA/334587/2020
Under evaluation
Opinion provided by Committee for Medicinal Products for Human Use
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.