Gelisia and associated names - referral

Current status

European Commission final decision

Overview

EMA recommends authorisation of Gelisia (timolol, eye gel) in the EU

On 15 December 2022, the European Medicines Agency completed a review of Gelisia following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Gelisia outweigh its risks, and the marketing authorisation should be granted in the Netherlands and in the following Member States of the EU: France, Germany, Italy, Romania and Spain.

What is Gelisia?

Gelisia is an eye gel that is used to reduce pressure inside the eye in adults who have ocular hypertension (when the pressure in the eye is higher than normal) or open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye).

The marketing authorisation application for Gelisia is a hybrid application. This means that the developer asked for it to be authorised on the basis that it was equivalent to a ‘reference medicine’ containing the same active substance in a gel formulation. The reference medicine for Gelisia is Geltim.

Gelisia contains the active substance timolol maleate.

Why was Gelisia reviewed?

The applicant for Gelisia, SIFI S.p.A., submitted an application to the Netherlands for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance France, Germany, Italy, Romania and Spain) where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement and the Dutch medicines regulatory agency referred the matter to EMA for arbitration on 22 October 2022.

The grounds for the referral were concerns raised by Spain. The Spanish medicines regulatory agency considered that additional testing and further statistical analyses of the results should have been carried out by the company to demonstrate that Gelisia and the reference medicine have similar viscosity (consistency of the gel) and equivalent therapeutic effects.

What is the outcome of the review?

The European Medicines Agency reviewed the totality of the data provided by the company, including additional statistical analyses that confirmed that the medicines have similar viscosity. The Agency considered that the data provided were sufficient to demonstrate that Gelisia and the reference medicine have equivalent therapeutic effects.

The Agency concluded that the benefits of Gelisia outweigh its risks, and therefore the marketing authorisation for Gelisia should be granted in all concerned Member States.

More about the procedure

The review of Gelisia was initiated on 10 November 2022 at the request of the Netherlands, under Article 29(4) of Directive 2001/83/EC.

The review was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.

The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Gelisia on 27 February 2023.

Gelisia Article 29(4) referral - EMA recommends authorisation of Gelisia (timolol, eye gel) in the EU

Reference Number: EMA/101846/2023

Key facts

About this medicine

• Approved name:
  Gelisia and associated names
• International non-proprietary name (INN) or common name:
  timolol maleate
• Associated names:
  • Genoptol
  • Gelisia
  • Timolol sifi 1 mg/g gel oftalmico

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1522
• 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.

• Authorisation model:
  Nationally authorised product(s)
• Decision making model:
  CHMP-EC

Key dates and outcomes

• CHMP opinion date:
  15/12/2022
• EC decision date:
  27/02/2023

All documents

Opinion provided by Committee for Medicinal Products for human Use

Gelisia Article 29(4) referral - EMA recommends authorisation of Gelisia (timolol, eye gel) in the EU

Reference Number: EMA/931490/2022

European Commission final decision

Gelisia Article 29(4) referral - Annex I

Gelisia Article 29(4) referral - Annex II

Gelisia Article 29(4) referral - Annex III

Gelisia Article 29(4) referral - Assessment report

AdoptedReference Number: EMA/1638/2023

Gelisia Article 29(4) referral - EMA recommends authorisation of Gelisia (timolol, eye gel) in the EU

Reference Number: EMA/101846/2023

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.