Linoladiol N and Linoladiol HN

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

Overview

The European Medicines Agency recommendations on the use of Linoladiol N and Linoladiol HN estradiol-containing creams

A limit to the duration of use and other measures put in place to manage potential risk of side effects

On 25 April 2014, the EMA's Committee for Medicinal Products for Human Use (CHMP) updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.

The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area. Treatment with both creams should be limited to a maximum duration of 4 weeks.

In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.

In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use. Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have been updated, taking into account new measures to manage the potential risk of side effects.

The CHMP reiterated the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body). Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer. The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.

In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.

The CHMP's recommendations were sent to the European Commission which endorsed them and issued a final, legally binding decision valid throughout the EU on 19 August 2014.

Key facts

Approved name
Linoladiol N and Linoladiol HN
International non-proprietary name (INN) or common name
estradiol
Class
hormonal
Reference number
EMEA/H/A-31/1336
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
25/04/2014
EC decision date
19/08/2014

All documents

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.

How useful was this page?

Add your rating