Implanon - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Implanon outweigh its risks, and that the marketing authorisation granted in the Netherlands can be recognised in other Member States of the European Union.
The review was carried out under an 'Article 29' referral¹.

The European Commission issued a decision on 6 February 2009.

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Implanon?

Implanon is a female contraceptive. It is presented as a small rod that is implanted by a doctor or a nurse using a special applicator just under the skin of the upper arm.

The active substance in Implanon, etonogestrel, is a synthetic female hormone resembling progesterone. Once implanted, the rod releases a small amount of etonogestrel continuously into the bloodstream. This changes the body's hormonal balance and help to prevent ovulation. Implanon can protect for up to three years; at the end of this period the implant must be removed.

Why was Implanon reviewed?

N.V. Organon submitted Implanon for a second renewal of the marketing authorisation through mutual recognition on the basis of the initial authorisation granted by the Netherlands on 25 August 1998. The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised. These member states were not able to reach an agreement. On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.

The grounds for the referral were concerns regarding the side effects related to insertion and removal of the implant, the risk of breast cancer, the incidence of irregular bleedings leading to premature removal of the implant. Additionally, the data on effectiveness in obese women in particular in the third year of use was considered insufficient.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Implanon outweigh its risks, and therefore the renewal of the marketing authorisation for Implanon should be granted in all concerned member states.

The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.

Questions and answers on the referral for Implanon subdermal implant etonogestrel 68 mg

AdoptedReference Number: EMEA/124262/2009

Key facts

About this medicine

• Approved name:
  Implanon
• International non-proprietary name (INN) or common name:
  etonogestrel

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/85200/2009
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  21/11/2008
• EC decision date:
  06/02/2009

All documents

Implanon - Article 29 referral - Annex I, II, III

Adopted

Questions and answers on the referral for Implanon subdermal implant etonogestrel 68 mg

AdoptedReference Number: EMEA/124262/2009

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.