Tavanic

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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 solution for infusion and tablets.

The European Commission issued a decision on 31 July 2012.

Name Language First published Last updated
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) BG = bălgarski 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) ES = español 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) CS = čeština 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) DA = dansk 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) DE = Deutsch 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) ET = eesti keel 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) EL = elliniká 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) EN = English 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) FR = français 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) IT = italiano 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) LV = latviešu valoda 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) LT = lietuvių kalba 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) HU = magyar 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) MT = Malti 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) NL = Nederlands 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) PL = polski 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) PT = português 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) RO = română 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SK = slovenčina 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SL = slovenščina 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) FI = suomi 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SV = svenska 2012-05-25 2012-09-12

Key facts

Approved nameTavanic
International non-proprietary name (INN) or common name

Tavanic and associated names

Associated nameslevofloxacin
Class
Reference numberEMEA/H/A-30/1262
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 date24/05/2012

All documents

Name Language First published Last updated
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) BG = bălgarski 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) ES = español 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) CS = čeština 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) DA = dansk 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) DE = Deutsch 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) ET = eesti keel 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) EL = elliniká 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) EN = English 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) FR = français 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) IT = italiano 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) LV = latviešu valoda 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) LT = lietuvių kalba 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) HU = magyar 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) MT = Malti 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) NL = Nederlands 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) PL = polski 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) PT = português 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) RO = română 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SK = slovenčina 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SL = slovenščina 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) FI = suomi 2012-05-25 2012-09-12
Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion) SV = svenska 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Assessment Report (English only) 2012-09-12  
Tavanic - Article 30 referral - Annex I BG = bălgarski 2012-09-12  
Tavanic - Article 30 referral - Annex I ES = español 2012-09-12  
Tavanic - Article 30 referral - Annex I CS = čeština 2012-09-12  
Tavanic - Article 30 referral - Annex I DA = dansk 2012-09-12  
Tavanic - Article 30 referral - Annex I DE = Deutsch 2012-09-12  
Tavanic - Article 30 referral - Annex I ET = eesti keel 2012-09-12  
Tavanic - Article 30 referral - Annex I EL = elliniká 2012-09-12  
Tavanic - Article 30 referral - Annex I EN = English 2012-09-12  
Tavanic - Article 30 referral - Annex I FR = français 2012-09-12  
Tavanic - Article 30 referral - Annex I IT = italiano 2012-09-12  
Tavanic - Article 30 referral - Annex I LV = latviešu valoda 2012-09-12  
Tavanic - Article 30 referral - Annex I LT = lietuvių kalba 2012-09-12  
Tavanic - Article 30 referral - Annex I HU = magyar 2012-09-12  
Tavanic - Article 30 referral - Annex I MT = Malti 2012-09-12  
Tavanic - Article 30 referral - Annex I NL = Nederlands 2012-09-12  
Tavanic - Article 30 referral - Annex I PL = polski 2012-09-12  
Tavanic - Article 30 referral - Annex I PT = português 2012-09-12  
Tavanic - Article 30 referral - Annex I RO = română 2012-09-12  
Tavanic - Article 30 referral - Annex I SK = slovenčina 2012-09-12  
Tavanic - Article 30 referral - Annex I SL = slovenščina 2012-09-12  
Tavanic - Article 30 referral - Annex I FI = suomi 2012-09-12  
Tavanic - Article 30 referral - Annex I SV = svenska 2012-09-12  
Tavanic - Article 30 referral - Annex II BG = bălgarski 2012-09-12  
Tavanic - Article 30 referral - Annex II ES = español 2012-09-12  
Tavanic - Article 30 referral - Annex II CS = čeština 2012-09-12  
Tavanic - Article 30 referral - Annex II DA = dansk 2012-09-12  
Tavanic - Article 30 referral - Annex II DE = Deutsch 2012-09-12  
Tavanic - Article 30 referral - Annex II ET = eesti keel 2012-09-12  
Tavanic - Article 30 referral - Annex II EL = elliniká 2012-09-12  
Tavanic - Article 30 referral - Annex II EN = English 2012-09-12  
Tavanic - Article 30 referral - Annex II FR = français 2012-09-12  
Tavanic - Article 30 referral - Annex II IT = italiano 2012-09-12  
Tavanic - Article 30 referral - Annex II LV = latviešu valoda 2012-09-12  
Tavanic - Article 30 referral - Annex II LT = lietuvių kalba 2012-09-12  
Tavanic - Article 30 referral - Annex II HU = magyar 2012-09-12  
Tavanic - Article 30 referral - Annex II MT = Malti 2012-09-12  
Tavanic - Article 30 referral - Annex II NL = Nederlands 2012-09-12  
Tavanic - Article 30 referral - Annex II PL = polski 2012-09-12  
Tavanic - Article 30 referral - Annex II PT = português 2012-09-12  
Tavanic - Article 30 referral - Annex II RO = română 2012-09-12  
Tavanic - Article 30 referral - Annex II SK = slovenčina 2012-09-12  
Tavanic - Article 30 referral - Annex II SL = slovenščina 2012-09-12  
Tavanic - Article 30 referral - Annex II FI = suomi 2012-09-12  
Tavanic - Article 30 referral - Annex II SV = svenska 2012-09-12  
Tavanic - Article 30 referral - Annex III (solution for infusion) BG = bălgarski 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) ES = español 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) CS = čeština 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) DA = dansk 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) DE = Deutsch 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) ET = eesti keel 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) EL = elliniká 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) EN = English 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) FR = français 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) IT = italiano 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) LV = latviešu valoda 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) LT = lietuvių kalba 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) HU = magyar 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) MT = Malti 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) NL = Nederlands 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) PL = polski 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) PT = português 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) RO = română 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) SK = slovenčina 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) SL = slovenščina 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) FI = suomi 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (solution for infusion) SV = svenska 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) BG = bălgarski 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) ES = español 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) CS = čeština 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) DA = dansk 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) DE = Deutsch 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) ET = eesti keel 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) EL = elliniká 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) EN = English 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) FR = français 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) IT = italiano 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) LV = latviešu valoda 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) LT = lietuvių kalba 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) HU = magyar 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) MT = Malti 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) NL = Nederlands 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) PL = polski 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) PT = português 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) RO = română 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) SK = slovenčina 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) SL = slovenščina 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) FI = suomi 2012-05-25 2012-09-12
Tavanic - Article 30 referral - Annex III (tablets) SV = svenska 2012-05-25 2012-09-12

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

More information on Tavanic