Levonelle 1500 microgram tablets and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Levonelle Article-13 referral - Questions and answers on Levonelle and associated names (levonorgestrel, 1500 microgram tablets) (PDF/79.4 KB)
First published: 27/05/2016
Last updated: 09/08/2016
EMA/517526/2016 -
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Levonelle Article-13 referral - CHMP assessment report (PDF/732.26 KB)
First published: 09/08/2016
Last updated: 09/08/2016
EMA/517526/2016 -
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Levonelle Article-13 referral - Annex I (PDF/68.55 KB)
First published: 09/08/2016
Last updated: 09/08/2016 -
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Levonelle Article-13 referral - Annex II (PDF/95.9 KB)
First published: 09/08/2016
Last updated: 09/08/2016 -
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Levonelle Article-13 referral - Annex III (PDF/64.12 KB)
First published: 27/05/2016
Last updated: 09/08/2016 -
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