Scandonest and associated names

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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.

Name Language First published Last updated
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised BG = bălgarski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised ES = español 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised CS = čeština 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised DA = dansk 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised DE = Deutsch 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised ET = eesti keel 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised EL = elliniká 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised EN = English 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised FR = français 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised IT = italiano 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised LV = latviešu valoda 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised LT = lietuvių kalba 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised HU = magyar 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised MT = Malti 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised NL = Nederlands 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised PL = polski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised PT = português 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised RO = română 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SK = slovenčina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SL = slovenščina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised FI = suomi 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SV = svenska 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised HR = Hrvatski 2018-06-01 2018-08-07

Key facts

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

mepivacaine

Associated namesBiocaine, Scandicaine
ClassAnaesthetic
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.

StatusEuropean Commission final decision
Opinion date31/05/2018

All documents

Name Language First published Last updated
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised BG = bălgarski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised ES = español 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised CS = čeština 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised DA = dansk 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised DE = Deutsch 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised ET = eesti keel 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised EL = elliniká 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised EN = English 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised FR = français 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised IT = italiano 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised LV = latviešu valoda 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised LT = lietuvių kalba 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised HU = magyar 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised MT = Malti 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised NL = Nederlands 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised PL = polski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised PT = português 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised RO = română 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SK = slovenčina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SL = slovenščina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised FI = suomi 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised SV = svenska 2018-06-01 2018-08-07
Scandonest Article-30 referral - Use of Scandonest and associated names (mepivacaine) to be harmonised HR = Hrvatski 2018-06-01 2018-08-07
Scandonest Article-30 referral - CHMP assessment report (English only) 2018-08-07  
Scandonest Article-30 referral - Annex I BG = bălgarski 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I ES = español 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I CS = čeština 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I DA = dansk 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I DE = Deutsch 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I ET = eesti keel 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I EL = elliniká 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I EN = English 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I FR = français 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I IT = italiano 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I LV = latviešu valoda 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I LT = lietuvių kalba 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I HU = magyar 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I MT = Malti 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I NL = Nederlands 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I PL = polski 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I PT = português 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I RO = română 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I SK = slovenčina 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I SL = slovenščina 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I FI = suomi 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I SV = svenska 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I HR = Hrvatski 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex I NO = Norsk 2017-09-15 2018-08-07
Scandonest Article-30 referral - Annex II BG = bălgarski 2018-08-07  
Scandonest Article-30 referral - Annex II ES = español 2018-08-07  
Scandonest Article-30 referral - Annex II CS = čeština 2018-08-07  
Scandonest Article-30 referral - Annex II DA = dansk 2018-08-07  
Scandonest Article-30 referral - Annex II DE = Deutsch 2018-08-07  
Scandonest Article-30 referral - Annex II ET = eesti keel 2018-08-07  
Scandonest Article-30 referral - Annex II EL = elliniká 2018-08-07  
Scandonest Article-30 referral - Annex II EN = English 2018-08-07  
Scandonest Article-30 referral - Annex II FR = français 2018-08-07  
Scandonest Article-30 referral - Annex II IT = italiano 2018-08-07  
Scandonest Article-30 referral - Annex II LV = latviešu valoda 2018-08-07  
Scandonest Article-30 referral - Annex II LT = lietuvių kalba 2018-08-07  
Scandonest Article-30 referral - Annex II HU = magyar 2018-08-07  
Scandonest Article-30 referral - Annex II MT = Malti 2018-08-07  
Scandonest Article-30 referral - Annex II NL = Nederlands 2018-08-07  
Scandonest Article-30 referral - Annex II PL = polski 2018-08-07  
Scandonest Article-30 referral - Annex II PT = português 2018-08-07  
Scandonest Article-30 referral - Annex II RO = română 2018-08-07  
Scandonest Article-30 referral - Annex II SK = slovenčina 2018-08-07  
Scandonest Article-30 referral - Annex II SL = slovenščina 2018-08-07  
Scandonest Article-30 referral - Annex II FI = suomi 2018-08-07  
Scandonest Article-30 referral - Annex II SV = svenska 2018-08-07  
Scandonest Article-30 referral - Annex II HR = Hrvatski 2018-08-07  
Scandonest Article-30 referral - Annex III BG = bălgarski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III ES = español 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III CS = čeština 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III DA = dansk 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III DE = Deutsch 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III ET = eesti keel 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III EL = elliniká 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III EN = English 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III FR = français 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III IT = italiano 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III LV = latviešu valoda 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III LT = lietuvių kalba 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III HU = magyar 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III MT = Malti 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III NL = Nederlands 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III PL = polski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III PT = português 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III RO = română 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III SK = slovenčina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III SL = slovenščina 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III FI = suomi 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III SV = svenska 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III HR = Hrvatski 2018-06-01 2018-08-07
Scandonest Article-30 referral - Annex III NO = Norsk 2018-06-01 2018-08-07
Scandonest Article-30 referral - Review started (English only) 2017-09-15  
Scandonest Article-30 referral - Timetable for the procedure (English only) 2017-09-15 2018-02-26
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:
European Commission final decision

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