Lovenox and associated names

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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).

What is Lovenox?

Lovenox is an anticoagulant medicine (a medicine to prevent blood clots) used in adults to prevent and treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg), as well as unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart) and certain types of myocardial infarction (heart attack);
Lovenox contains the active substance enoxaparin. It is available as vials, ampoules, prefilled syringes and pens and is given by injection under the skin or into a vein.

Lovenox is available in all EU countries. It is also available under other trade names: Clexane, Clexane T, Clexane Forte, Klexane, Qualiop, Enoxaparin Sanofi and Enoxaparine Sanofi. The company that markets these medicines is Sanofi.

Why was Lovenox reviewed?

Lovenox is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Lovenox was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 12 November 2015, France referred the matter to the CHMP in order to harmonise the marketing authorisations for Lovenox in the EU.

What are the conclusions of the CHMP?

The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

The CHMP agreed that the strength of the active substance enoxaparin will now be expressed both in international units (IU) and in milligram (mg) throughout the product information.

4.1 Therapeutic indications

The CHMP agreed that Lovenox can be used for the following uses:

  • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they have reduced mobility due to illness;
  • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg) or pulmonary embolism (clot in a blood vessel supplying the lung);
  • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
  • to treat certain types of myocardial infarction (heart attack);
  • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.

4.2 Posology and method of administration

For the treatment of deep vein thrombosis and pulmonary embolism, the CHMP also clarified that the dose regimen of 150 IU/kg (1.5 mg/kg) given once daily should only be used only in uncomplicated patients who have a low risk of a further venous thromboembolism. Patients at higher risk should be given 100 IU/kg (1 mg/kg) twice daily.

The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.

This section was also updated to reflect that outside its approved use in haemodialysis Lovenox is not recommended in patients with end stage kidney disease. A table with dosing recommendations in this group was included.

4.3 Contraindications

A contraindication that existed in some EU member states for use in patients with severe kidney impairment was removed.

The Committee also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use of machines) and 4.8 (undesirable effects).

The European Commission issued a decision on this opinion on 9/03/2017.

Name Language First published Last updated
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) BG = bălgarski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) ES = español 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) CS = čeština 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) DA = dansk 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) DE = Deutsch 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) EL = elliniká 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) EN = English 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) FR = français 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) IT = italiano 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) LV = latviešu valoda 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) LT = lietuvių kalba 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) HU = magyar 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) MT = Malti 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) NL = Nederlands 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) PL = polski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) PT = português 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) RO = română 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SK = slovenčina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SL = slovenščina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SV = svenska 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) HR = Hrvatski 2016-12-16 2017-03-22

Key facts

Approved nameLovenox and associated names
International non-proprietary name (INN) or common name

enoxaparin

Associated names
Class
Reference numberEMEA/H/A-30/1429
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date15/12/2016

All documents

Name Language First published Last updated
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) BG = bălgarski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) ES = español 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) CS = čeština 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) DA = dansk 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) DE = Deutsch 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) EL = elliniká 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) EN = English 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) FR = français 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) IT = italiano 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) LV = latviešu valoda 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) LT = lietuvių kalba 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) HU = magyar 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) MT = Malti 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) NL = Nederlands 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) PL = polski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) PT = português 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) RO = română 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SK = slovenčina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SL = slovenščina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) SV = svenska 2016-12-16 2017-03-22
Lovenox Article 30 referral - Questions and answers on Lovenox and associated names (enoxaparin, solution for injection) HR = Hrvatski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Assessment report (English only) 2017-03-22  
Lovenox Article 30 referral - Annex I BG = bălgarski 2017-03-22  
Lovenox Article 30 referral - Annex I ES = español 2017-03-22  
Lovenox Article 30 referral - Annex I CS = čeština 2017-03-22  
Lovenox Article 30 referral - Annex I DA = dansk 2017-03-22  
Lovenox Article 30 referral - Annex I DE = Deutsch 2017-03-22  
Lovenox Article 30 referral - Annex I ET = eesti keel 2017-03-22  
Lovenox Article 30 referral - Annex I EL = elliniká 2017-03-22  
Lovenox Article 30 referral - Annex I EN = English 2017-03-22  
Lovenox Article 30 referral - Annex I FR = français 2017-03-22  
Lovenox Article 30 referral - Annex I IT = italiano 2017-03-22  
Lovenox Article 30 referral - Annex I LV = latviešu valoda 2017-03-22  
Lovenox Article 30 referral - Annex I LT = lietuvių kalba 2017-03-22  
Lovenox Article 30 referral - Annex I HU = magyar 2017-03-22  
Lovenox Article 30 referral - Annex I MT = Malti 2017-03-22  
Lovenox Article 30 referral - Annex I NL = Nederlands 2017-03-22  
Lovenox Article 30 referral - Annex I PL = polski 2017-03-22  
Lovenox Article 30 referral - Annex I PT = português 2017-03-22  
Lovenox Article 30 referral - Annex I RO = română 2017-03-22  
Lovenox Article 30 referral - Annex I SK = slovenčina 2017-03-22  
Lovenox Article 30 referral - Annex I SL = slovenščina 2017-03-22  
Lovenox Article 30 referral - Annex I FI = suomi 2017-03-22  
Lovenox Article 30 referral - Annex I SV = svenska 2017-03-22  
Lovenox Article 30 referral - Annex I HR = Hrvatski 2017-03-22  
Lovenox Article 30 referral - Annex I IS = Islenska 2017-03-22  
Lovenox Article 30 referral - Annex I NO = Norsk 2017-03-22  
Lovenox Article 30 referral - Annex II BG = bălgarski 2017-03-22  
Lovenox Article 30 referral - Annex II ES = español 2017-03-22  
Lovenox Article 30 referral - Annex II CS = čeština 2017-03-22  
Lovenox Article 30 referral - Annex II DA = dansk 2017-03-22  
Lovenox Article 30 referral - Annex II DE = Deutsch 2017-03-22  
Lovenox Article 30 referral - Annex II ET = eesti keel 2017-03-22  
Lovenox Article 30 referral - Annex II EL = elliniká 2017-03-22  
Lovenox Article 30 referral - Annex II EN = English 2017-03-22  
Lovenox Article 30 referral - Annex II FR = français 2017-03-22  
Lovenox Article 30 referral - Annex II IT = italiano 2017-03-22  
Lovenox Article 30 referral - Annex II LV = latviešu valoda 2017-03-22  
Lovenox Article 30 referral - Annex II LT = lietuvių kalba 2017-03-22  
Lovenox Article 30 referral - Annex II HU = magyar 2017-03-22  
Lovenox Article 30 referral - Annex II MT = Malti 2017-03-22  
Lovenox Article 30 referral - Annex II NL = Nederlands 2017-03-22  
Lovenox Article 30 referral - Annex II PL = polski 2017-03-22  
Lovenox Article 30 referral - Annex II PT = português 2017-03-22  
Lovenox Article 30 referral - Annex II RO = română 2017-03-22  
Lovenox Article 30 referral - Annex II SK = slovenčina 2017-03-22  
Lovenox Article 30 referral - Annex II SL = slovenščina 2017-03-22  
Lovenox Article 30 referral - Annex II FI = suomi 2017-03-22  
Lovenox Article 30 referral - Annex II SV = svenska 2017-03-22  
Lovenox Article 30 referral - Annex II HR = Hrvatski 2017-03-22  
Lovenox Article 30 referral - Annex II IS = Islenska 2017-03-22  
Lovenox Article 30 referral - Annex II NO = Norsk 2017-03-22  
Lovenox Article 30 referral - Annex III BG = bălgarski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III ES = español 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III CS = čeština 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III DA = dansk 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III DE = Deutsch 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III ET = eesti keel 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III EL = elliniká 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III EN = English 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III FR = français 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III IT = italiano 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III LV = latviešu valoda 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III LT = lietuvių kalba 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III HU = magyar 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III MT = Malti 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III NL = Nederlands 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III PL = polski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III PT = português 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III RO = română 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III SK = slovenčina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III SL = slovenščina 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III FI = suomi 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III SV = svenska 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III HR = Hrvatski 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III IS = Islenska 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex III NO = Norsk 2016-12-16 2017-03-22
Lovenox Article 30 referral - Annex IV BG = bălgarski 2017-03-22  
Lovenox Article 30 referral - Annex IV ES = español 2017-03-22  
Lovenox Article 30 referral - Annex IV CS = čeština 2017-03-22  
Lovenox Article 30 referral - Annex IV DA = dansk 2017-03-22  
Lovenox Article 30 referral - Annex IV DE = Deutsch 2017-03-22  
Lovenox Article 30 referral - Annex IV ET = eesti keel 2017-03-22  
Lovenox Article 30 referral - Annex IV EL = elliniká 2017-03-22  
Lovenox Article 30 referral - Annex IV EN = English 2017-03-22  
Lovenox Article 30 referral - Annex IV FR = français 2017-03-22  
Lovenox Article 30 referral - Annex IV IT = italiano 2017-03-22  
Lovenox Article 30 referral - Annex IV LV = latviešu valoda 2017-03-22  
Lovenox Article 30 referral - Annex IV LT = lietuvių kalba 2017-03-22  
Lovenox Article 30 referral - Annex IV HU = magyar 2017-03-22  
Lovenox Article 30 referral - Annex IV MT = Malti 2017-03-22  
Lovenox Article 30 referral - Annex IV NL = Nederlands 2017-03-22  
Lovenox Article 30 referral - Annex IV PL = polski 2017-03-22  
Lovenox Article 30 referral - Annex IV PT = português 2017-03-22  
Lovenox Article 30 referral - Annex IV RO = română 2017-03-22  
Lovenox Article 30 referral - Annex IV SK = slovenčina 2017-03-22  
Lovenox Article 30 referral - Annex IV SL = slovenščina 2017-03-22  
Lovenox Article 30 referral - Annex IV FI = suomi 2017-03-22  
Lovenox Article 30 referral - Annex IV SV = svenska 2017-03-22  
Lovenox Article 30 referral - Annex IV HR = Hrvatski 2017-03-22  

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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