Scandonest and associated names

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EMA starts review of Scandonest (mepivacaine 30 mg/ml solution for injection)

The European Medicines Agency (EMA) has started a review of the medicine Scandonest, a local anaesthetic (a medicine used to block pain in a part of the body) that contains the active substance mepivacaine.

Scandonest has been authorised in several Member States of the EU via national procedures. This has led to divergences across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information (summaries of product characteristics, labelling and package leaflets) in the countries where the medicine is available.

EMA will consider the available data on Scandonest and will amend the prescribing information to harmonise the way Scandonest is used in the EU.

The amended information for doctors and patients will be available on the EMA website once the review is concluded.

More about the medicine

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 and can be used during dental and chiropody (treatment of corns, verrucae, etc.) procedures.

Scandonest is also available in the EU under the trade names Biocaine and Scandicaine. It contains the active substance mepivacaine.

More about the procedure

The review of Scandonest has been initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.

The review is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in EU Member States.

Name Language First published Last updated
Scandonest Article-30 referral - Review started (English only) 2017-09-15  

Key facts

Approved nameScandonest and associated names
International non-proprietary name (INN) or common name

mepivacaine

Associated names
Class
Reference numberEMEA/H/A-30/1455
TypeArticle 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 European Union.

StatusProcedure started
Opinion date14/09/2017

All documents

Name Language First published Last updated
Scandonest Article-30 referral - Review started (English only) 2017-09-15  
Scandonest Article-30 referral - Timetable for the procedure (English only) 2017-09-15 2017-10-13
Scandonest Article-30 referral - Annex I (English only) 2017-09-15  
Scandonest Article-30 referral - Notification (English only) 2017-09-15  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
Procedure started

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