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.
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.
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 European Commission issued a decision on 31 July 2012.
|International non-proprietary name (INN) or common name|
Tavanic and associated names
|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 European Union.
|Status||European Commission final decision|
- 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