Lovenox and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
Questions and answers on Lovenox and associated names (enoxaparin, solution for injection)
Outcome of a procedure under Article 30 of Directive 2001/83/EC
On 15 December 2016, the European Medicines Agency completed a review of Lovenox and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Lovenox in the European Union (EU).
Key facts
Approved name |
Lovenox and associated names
|
International non-proprietary name (INN) or common name |
enoxaparin |
Reference number |
EMEA/H/A-30/1429
|
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 |
15/12/2016
|
EC decision date |
09/03/2017
|
All documents
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Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) (PDF/83.11 KB)
First published: 16/12/2016
Last updated: 22/03/2017
EMA/837288/2016 -
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Lovenox Article 30 referral - Assessment report (PDF/296.23 KB)
First published: 22/03/2017
Last updated: 22/03/2017
EMA/134171/2017 -
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Lovenox Article 30 referral - Annex I (PDF/596.58 KB)
First published: 22/03/2017
Last updated: 22/03/2017 -
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Lovenox Article 30 referral - Annex II (PDF/83.62 KB)
First published: 22/03/2017
Last updated: 22/03/2017 -
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Lovenox Article 30 referral - Annex III (PDF/1.39 MB)
First published: 16/12/2016
Last updated: 22/03/2017 -
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Lovenox Article 30 referral - Annex IV (PDF/26.91 KB)
First published: 22/03/2017
Last updated: 22/03/2017 -
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