Scandonest and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
Use of Scandonest and associated names (mepivacaine) to be harmonised
Information for doctors and patients to be aligned across EU
On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Key facts
Approved name |
Scandonest and associated names
|
International non-proprietary name (INN) or common name |
mepivacaine |
Associated names |
|
Class |
Anaesthetic
|
Reference number |
EMEA/H/A-30/1455
|
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 |
31/05/2018
|
EC decision date |
02/08/2018
|
All documents
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Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised (PDF/78.31 KB)
First published: 01/06/2018
Last updated: 07/08/2018
EMA/356909/2018 Rev. 1 -
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Scandonest Article-30 referral - CHMP assessment report (PDF/209.67 KB)
First published: 07/08/2018
Last updated: 07/08/2018
EMA/413109/2018 -
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Scandonest Article-30 referral - Annex I (PDF/87.68 KB)
First published: 15/09/2017
Last updated: 07/08/2018
EMA/594289/2017 -
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Scandonest Article-30 referral - Annex II (PDF/58.82 KB)
First published: 07/08/2018
Last updated: 07/08/2018 -
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Scandonest Article-30 referral - Annex III (PDF/352.83 KB)
First published: 01/06/2018
Last updated: 07/08/2018 -
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Scandonest Article-30 referral - Review started (PDF/73.66 KB)
First published: 15/09/2017
Last updated: 15/09/2017
EMA/599131/2017 -
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Scandonest Article-30 referral - Timetable for the procedure (PDF/79.3 KB)
First published: 15/09/2017
Last updated: 26/02/2018
EMA/CHMP/563882/2017 -
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Scandonest Article-30 referral - Notification (PDF/260.6 KB)
First published: 15/09/2017
Last updated: 15/09/2017
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