Scandonest and associated names - referral

Current status

European Commission final decision

Overview

Use of Scandonest and associated names (mepivacaine) to be harmonised

Information for doctors and patients to be aligned across EU

On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.

What is Scandonest?

Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures. Scandonest is given by injection. It contains the active substance mepivacaine.

Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.

The company that markets these medicines is Septodont.

Why was Scandonest reviewed?

Scandonest has been authorised in the EU via national procedures. This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.

On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.

What is the outcome of the review?

After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised. The areas harmonised include:

4.1 Therapeutic indications

Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).

Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.

4.2 Posology and method of administration

The recommended dose of Scandonest depends on the patient's age and body weight. In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg. In children, the recommended dose is 0.75 mg/kg.

4.3 Contraindications

Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine. In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.

After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above. Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.

Other changes

Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).

The package leaflet will be updated accordingly.

The amended information to doctors and patients is available.

In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.

More about the procedure

The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 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 to implement these changes on 2 August 2018.

Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised

Reference Number: EMA/356909/2018 Rev. 1

Key facts

About this medicine

• Approved name:
  Scandonest and associated names
• International non-proprietary name (INN) or common name:
  mepivacaine
• Associated names:
  • Biocaine
  • Scandicaine
• Class:
  Anaesthetic

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1455
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  31/05/2018
• EC decision date:
  02/08/2018

All documents

Opinion provided by Committee for Medicinal Products for human Use

Scandonest Article-30 referral - Review started

Reference Number: EMA/599131/2017

Scandonest Article-30 referral - Timetable for the procedure

Reference Number: EMA/CHMP/563882/2017

Scandonest Article-30 referral - Notification

European Commission final decision

Scandonest Article-30 referral - CHMP assessment report

Reference Number: EMA/413109/2018

Scandonest Article-30 referral - Annex II

Scandonest Article-30 referral - Annex III

Scandonest Article-30 referral - Annex I

Reference Number: EMA/594289/2017

Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised

Reference Number: EMA/356909/2018 Rev. 1

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.