Estradiol-containing (0.01% w/w) medicinal products for topical use

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
Under evaluation

Overview

New review of risks with high-strength estradiol-containing creams

EMA has started a new review of high-strength estradiol-containing creams (0.01% w/w) that are used inside the vagina for treating women with vaginal atrophy who have been through menopause.

The review will assess the risk of estradiol being absorbed systemically (throughout the body) from these creams. Systemic absorption is of concern because it may result in similar side effects to those associated with the use of estradiol in systemic hormone replacement therapy (HRT), which include venous thromboembolism (formation of blood clots in the veins), stroke and endometrial cancer (cancer of the lining of the womb).

In 2014, EMA completed a review of the risk of systemic absorption with high-strength estradiol creams and recommended measures to minimise it, including limiting the use of the creams to a maximum duration of 4 weeks. However, in March 2019 the EU Court of Justice partially annulled the conclusions of the review on procedural grounds. Although the Court of Justice did not question the scientific conclusions, the partial annulment means that some of the measures taken to minimise the risk have been invalidated.

The European Commission has therefore asked EMA to reassess this risk, taking into account both the original data and any new data that have become available since the previous review, and to recommend measures that should be put in place to protect patients. The review will be carried out by EMA’s safety committee (PRAC).

While the review is ongoing, women who have any questions or concerns about their treatment should speak to their doctor or pharmacist.

Key facts

About this medicine
Approved name
Estradiol-containing (0.01% w/w) medicinal products for topical use
International non-proprietary name (INN) or common name

 estradiol

Associated names
  • Linoladiol
  • Linoladiol N
  • Linoladiol Estradiol
  • Estradiol Wolff
  • Montadiol
Class
Hormonal
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-31/1482
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.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
11/04/2019

All documents

Procedure started

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

News

How useful was this page?

Add your rating