Tavanic - referral

Current status

European Commission final decision

Overview

On 24 May 2012 the European Medicines Agency completed a review of Tavanic. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the product information for Tavanic in the European Union (EU).

What is Tavanic?

Tavanic is an antibiotic that belongs to the group 'fluoroquinolones'. It works by blocking an enzyme that bacteria use to make copies of their DNA. By doing this, it stops the bacteria that are causing an infection from growing and multiplying. Tavanic is currently used to treat various infections and is available as tablets or solution for infusion.

Tavanic is marketed in the following EU Member States: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

The company that markets these medicines is Sanofi.

Why was Tavanic reviewed?

Tavanic is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Tavanic was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMDh).

On 11 October 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tavanic in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the use of the medicine, the CHMP agreed that:

• Tavanic 250 mg and 500 mg film-coated tablets are indicated in acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterial agents are not recommended. They are also indicated in pyelonephritis and complicated urinary tract infections (UTI), chronic bacterial prostatitis, uncomplicated cystitis and for the post-exposure prophylaxis and curative treatment of inhalation anthrax;
• Tavanic 5mg/ml solution for infusion is indicated in community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterials are not recommended. It is also indicated in pyelonephritis and complicated urinary tract infections (UTI), chronic bacterial prostatitis, and for the post-exposure prophylaxis and curative treatment of inhalation anthrax.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on the posology and frequency of administration of Tavanic, including the posology for acute exacerbations of chronic bronchitis and pyelonephritis.

4.3 Contra-indications

Based on the data reviewed, the CHMP decided a harmonisation of the contraindications of Tavanic in patients hypersensitive (allergic) to levofloxacin, any other quinolone or any of the excipients, in patients with epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, in children or growing adolescents, during pregnancy and in breast-feeding women.

Other changes

The CHMP also harmonised other sections of the SmPC including the addition of a new warning in section 4.4 recommending that an eye specialist should be consulted if vision becomes impaired or any effects on the eyes are experienced In addition, the Committee added new side effects in section 4.8 including ligament rupture, hypoglycaemic coma, benign intracranial hypertension, as well as palpitations and ventricular tachycardia, which may result in cardiac arrest.

The amended information to doctors and patients is available here for Tavanic - Article 30 referral - Annex III (solution for infusion) and Tavanic - Article 30 referral - Annex III (tablets).

The European Commission issued a decision on 31 July 2012.

Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion)

Adopted Reference Number: EMA/332109/2012

Key facts

About this medicine

• Approved name:
  Tavanic
• International non-proprietary name (INN) or common name:
  levofloxacin
• Associated names:
  Levofloxacin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1262
• 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:
  24/05/2012
• EC decision date:
  31/07/2012

All documents

Tavanic - Article 30 referral - Annex III (solution for infusion)

Adopted

Tavanic - Article 30 referral - Annex III (tablets)

Adopted

Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion)

Adopted Reference Number: EMA/332109/2012

European Commission final decision

Tavanic - Article 30 referral - Assessment Report

Tavanic - Article 30 referral - Annex I

Tavanic - Article 30 referral - Annex II

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.