Septanest and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other 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 |
Septanest and associated names
|
International non-proprietary name (INN) or common name |
articaine (hydrochloride) / adrenaline (tartrate) |
Class |
local anaesthetic
|
Reference number |
EMEA/H/A-30/1461
|
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 |
28/06/2018
|
EC decision date |
28/03/2019
|
All documents
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Septanest Article-30 referral - Use of Septanest and associated names (articaine / adrenaline solutions for injection) to be harmonised in EU (PDF/78.96 KB)
First published: 29/03/2019
Last updated: 19/06/2019
EMA/186900/2019 Rev.1 -
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Septanest Article-30 referral - Annex I (PDF/179.86 KB)
First published: 29/06/2018
Last updated: 19/06/2019
EMA/443931/2018 -
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Septanest Article-30 referral - Timetable for the procedure (PDF/90.33 KB)
First published: 29/06/2018
Last updated: 04/12/2018
EMA/CHMP/382271/2018 rev3 -
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Septanest Article-30 referral - Notification (PDF/285.29 KB)
First published: 29/06/2018
Last updated: 29/06/2018
EMA/443931/2018 -
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Septanest Article-30 referral - Review started (PDF/74.26 KB)
First published: 29/06/2018
Last updated: 29/06/2018
EMA/350884/2018 -
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Septanest Article-30 referral - Annex III (PDF/563.26 KB)
First published: 29/03/2019
Last updated: 19/06/2019 -
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Septanest Article-30 referral - CHMP assessment report (PDF/262.31 KB)
Adopted
First published: 04/06/2019
EMA/220146/2019 -
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Septanest Article-30 referral - Annex II (PDF/61.14 KB)
First published: 19/06/2019 -
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