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
About this medicine
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Approved name |
Septanest and associated names
|
International non-proprietary name (INN) or common name |
|
Class |
local anaesthetic
|
About this procedure
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Current status |
European Commission final decision
|
Reference number |
EMEA/H/A-30/1461
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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)
|
Key dates and outcomes
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|
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CHMP opinion date |
28/06/2018
|
EC decision date |
28/03/2019
|
All documents
Procedure started
List item
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
List item
Septanest Article-30 referral - Notification (PDF/285.29 KB)
First published: 29/06/2018
Last updated: 29/06/2018
EMA/443931/2018
List item
Septanest Article-30 referral - Review started (PDF/74.26 KB)
First published: 29/06/2018
Last updated: 29/06/2018
EMA/350884/2018
European Commission final decision
List item
Septanest Article-30 referral - Annex II (PDF/61.14 KB)
First published: 19/06/2019
List item
Septanest Article-30 referral - CHMP assessment report (PDF/262.31 KB)
Adopted
First published: 04/06/2019
EMA/220146/2019
First published: 04/06/2019
EMA/220146/2019
List item
Septanest Article-30 referral - Annex III (PDF/563.26 KB)
First published: 29/03/2019
Last updated: 19/06/2019
List item
Septanest Article-30 referral - Annex I (PDF/179.86 KB)
First published: 29/06/2018
Last updated: 19/06/2019
EMA/443931/2018
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.