Septanest and associated names - referral

Current status

European Commission final decision

Overview

On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.

What is Septanest?

Septanest is a local anaesthetic (a medicine for preventing pain and discomfort in a part of the body during medical procedures). It is given by injection. Septanest contains the active ingredient articaine together with adrenaline (epinephrine), which helps prolong articaine’s effects and restrict it to a particular area of the body.

Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.

The company that markets these medicines is Septodont.

Why was Septanest reviewed?

Septanest 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 - that is, the summary of product characteristics (SmPC), labelling and package leaflet - in the countries where the medicine is marketed.

On 4 June 2018, Septodont, the company that markets Septanest, referred the matter to EMA in order to harmonise the marketing authorisations for Septanest in the EU.

What is the outcome of the review?

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

4.1 Therapeutic indications

Septanest is now authorised for use as a local anaesthetic in dental procedures in adults, adolescents and children above 4 years of age (or weighing at least 20 kg).

4.2 Posology and method of administration

The recommended dose of Septanest depends on the patient’s body weight. The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.

4.3 Contraindications

Septanest must not be used in patients who are allergic to articaine or similar local anaesthetics (known as amide-type local anaesthetics) or to any other ingredient of the medicine. It must also not be given to patients with epilepsy who are not adequately controlled by treatment.

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 were considered redundant. 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 section 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), 4.8 (side effects), and 4.9 (overdose).

The package leaflet will be updated accordingly.

The amended information to doctors and patients is available in  Septanest Article-30 referral - Annex III.

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

More about the procedure

The review of Septanest was initiated on 29 June 2018 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.

A European Commission decision valid throughout the EU was issued on 27/05/2019.

Septanest Article-30 referral - Use of Septanest and associated names (articaine / adrenaline solutions for injection) to be harmonised in EU

Reference Number: EMA/186900/2019 Rev.1

Key facts

About this medicine

• Approved name:
  Septanest and associated names
• International non-proprietary name (INN) or common name:
  • articaine (hydrochloride)
  • adrenaline (tartrate)
• Class:
  local anaesthetic

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1461
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  28/06/2018
• EC decision date:
  28/03/2019

All documents

Procedure started

Septanest Article-30 referral - Timetable for the procedure

Reference Number: EMA/CHMP/382271/2018 rev3

Septanest Article-30 referral - Notification

Reference Number: EMA/443931/2018

Septanest Article-30 referral - Review started

Reference Number: EMA/350884/2018

Opinion provided by Committee for Medicinal Products for human Use

Septanest Article-30 referral - Use of Septanest and associated names (articaine / adrenaline solutions for injection) to be harmonised in EU

Reference Number: EMA/186900/2019 Rev.1

European Commission final decision

Septanest Article-30 referral - Annex II

Septanest Article-30 referral - CHMP assessment report

AdoptedReference Number: EMA/220146/2019

Septanest Article-30 referral - Annex III

Septanest Article-30 referral - Annex I

Reference Number: EMA/443931/2018

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.