Syner-Kinase and associated names - referral

Current status

European Commission final decision

Overview

EMA completes review following disagreement among EU Member States

On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.

What is Syner-Kinase?

Syner-Kinase is a medicine used to dissolve blood clots in the lungs, in deep veins, in arteries in the arms, hands, legs and feet, or in catheters or cannulae (surgical tubes) placed in a vein. Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body.

Why was Syner-Kinase reviewed?

The marketing authorisation holder, Syner-Medica Ltd, requested that the marketing authorisation for Syner-Kinase granted in the UK on 29 September 2006 be recognised in France, Germany, the Netherlands and Spain (the ‘concerned Member States’). However, the Member States were not able to reach an agreement and the UK medicines agency referred the matter to EMA for arbitration on 5 July 2018.

The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines, were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks. Concerns were also raised regarding the manufacturing and purification processes for the active substance urokinase, which is extracted from human urine.

What is the outcome of the review?

Having reviewed the available data, EMA considered that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data are adequate to support its proposed use. The Agency also considered that the data provided by the company show that the purification process is suitable for the removal of possible viral and prion impurities. Finally, the company demonstrated that the production of the semi-purified urokinase (an intermediate step in the production of the active substance) is adequately controlled, and that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).

Therefore, based on the evaluation of the available data, the Agency concluded that the benefits of Syner-Kinase outweigh its risks, and that the marketing authorisation for Syner-Kinase should be granted in all concerned Member States.

More about the procedure

The review of Syner-Kinase was initiated on 26 July 2018 at the request of the United Kingdom, 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.

A European Commission decision valid throughout the EU was issued on 16/05/2019. 

Syner-Kinase Article 29(4) referral - EMA recommends authorisation of Syner-Kinase (urokinase) in the EU

AdoptedReference Number: EMA/299749/2019

Key facts

About this medicine

• Approved name:
  Syner-Kinase and associated names
• International non-proprietary name (INN) or common name:
  urokinase

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA-H-A-29(4)-1472
• 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)

Key dates and outcomes

• CHMP opinion date:
  28/02/2019
• EC decision date:
  16/05/2019

All documents

Opinion provided by Committee for Medicinal Products for human Use

Syner-Kinase Article 29(4) referral - Annex III

European Commission final decision

Syner-Kinase Article 29(4) referral - CHMP assessment report

AdoptedReference Number: EMA/294785/2019

Syner-Kinase Article 29(4) referral - Annex II

Adopted

Syner-Kinase Article 29(4) referral - Annex I

Adopted

Syner-Kinase Article 29(4) referral - EMA recommends authorisation of Syner-Kinase (urokinase) in the EU

AdoptedReference Number: EMA/299749/2019

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.