Lidocain/Prilocain Idetec and associated names - referral

Current status

European Commission final decision

Overview

On 14 October 2021, the European Medicines Agency completed a review of Lidocain/Prilocain Idetec and associated names following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Lidocain/Prilocain Idetec could not be shown to outweigh its risks, and the marketing authorisation could not be granted in Denmark or in the other Member State of the EU where the company has applied for a marketing authorisation (in this case, the Netherlands).

In November 2021 EMA started a re-examination of its opinion at the request of the company; however, the re-examination procedure was stopped as the applicant decided to withdraw its application for marketing authorisation.

What is Lidocain/Prilocain Idetec?

Lidocain/Prilocain Idetec is a cream to be applied to the skin and genital area to prevent pain during minor surgical or medical procedures, and for the treatment of leg ulcers. It contains the active substances lidocaine and prilocaine, which are local anaesthetics that are absorbed through skin or the membranes of the genitals to numb the nerves in the area and prevent pain.

The marketing authorisation application for Lidocain/Prilocain Idetec was 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 substances in a complex cream formulation. The reference medicine for Lidocaine/Prilocain Idetec is EMLA 5% cream.

Why was Lidocain/Prilocain Idetec reviewed?

International Drug Development submitted Lidocain/Prilocain Idetec to the Danish Medicines Agency (Lægemiddelstyrelsen) for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Denmark) 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 the Netherlands) where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement and Denmark referred the matter to EMA for arbitration on 5 March 2021.

The grounds for the referral were the concerns of the Netherlands that equivalence between the therapeutic effect of Lidocain/Prilocain Idetec and that of its reference product, EMLA cream, had not been established based on the studies and references to the scientific literature that had been provided.

What is the outcome of the review?

Lidocain/Prilocain Idetec is a cream with a local action on the areas to which it is applied. In a hybrid application evidence has to be provided to show that the medicine is equivalent to the reference product, and so will have the same effects. Although the company provided data from a study under laboratory conditions and a clinical study in children, as well as information from scientific literature, EMA’s human medicines committee (CHMP) considered that the data provided were not sufficient to allow it to conclude on equivalence of effect.

Based on evaluation of the currently available data, the Agency therefore concluded that the benefits of Lidocain/Prilocain Idetec and associated names do not outweigh its risks, and that the marketing authorisation should not be granted in Denmark or the Netherlands.

More about the procedure

The review of Lidocain/Prilocain Idetec and associated names was initiated on 25 March 2021 at the request of Denmark, 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 CHMP opinion was forwarded to the European Commission, which issued a final decision valid throughout the EU on 28 March 2022.

Lidocain/Prilocain Idetec Referral Article-29(4) - EMA recommends refusal of authorisation for Lidocain/Prilocain Idetec and associated names (lidocaine/prilocaine cream)

Reference Number: EMA/567301/2021 Rev.2

Key facts

About this medicine

• Approved name:
  Lidocain/Prilocain Idetec and associated names
• International non-proprietary name (INN) or common name:
  • lidocaine
  • prilocaine
• Associated names:
  Lidocaïne / Prilocaïne 5% Focus, Crème

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29(4)/1506
• 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:
  14/10/2021

All documents

Opinion provided by Committee for Medicinal Products for human Use

Lidocain/Prilocain Idetec Referral Article-29(4) - Annex II

Lidocain/Prilocain Idetec Referral Article-29(4) - Annex I

Lidocain/Prilocain Idetec Referral Article-29(4) - Public Assessment Report including divergent positions to CHMP Opinion

AdoptedReference Number: EMA/CHMP/344182/2021

Lidocain/Prilocain Idetec Referral Article-29(4) - EMA recommends refusal of authorisation for Lidocain/Prilocain Idetec and associated names (lidocaine/prilocaine cream)

Reference Number: EMA/567301/2021 Rev.2

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.