Levonelle 1500 microgram tablets and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled. However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option. In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.

Key facts

Approved name
Levonelle 1500 microgram tablets and associated names
International non-proprietary name (INN) or common name
levonorgestrel
Reference number
EMEA/H/A-13/1427
Type
Article 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
26/05/2016
EC decision date
01/08/2016

All documents

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:

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