Zinnat

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

What is Zinnat?

Zinnat is an antibiotic used to treat certain infections caused by bacteria, including respiratory-tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary-tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).

The active substance, cefuroxime axetil, belongs to the group ‘cephalosporins’. It works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Zinnat is marketed in all EU Member States, as well as Iceland. It is also available under other trade names: Cefuroxima Solasma, Cefuroxima Allen, Cefuroxima Duncan, Elobact, Nivador, Oraxim, Selan, Tilexim, Zinadol, Zipos, Zoref.

The company that markets these medicines is GlaxoSmithKline.

Why was Zinnat reviewed?

Zinnat 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 different EU countries.

Zinnat was identified as needing harmonisation by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinnat 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

The CHMP agreed that Zinnat should no longer be used to treat community-acquired pneumonia (infection of the lungs acquired outside the hospital) and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae) because not enough clinical data are available to support these indications. The CHMP concluded that Zinnat should be used in adults and children from three months of age for the following conditions:

  • acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat);
  • acute bacterial sinusitis (infection of the sinuses);
  • acute otitis media (infection of the middle ear);
  • acute exacerbations (flares-up) of chronic bronchitis;
  • cystitis (infection of the bladder);
  • pyelonephritis (kidney infection);
  • uncomplicated skin and soft-tissue infections;
  • treatment of early Lyme disease.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinnat in adults and children and in patients with reduced kidney and liver function. Zinnat should be used twice a day at different doses depending on the condition it is used to treat.

The CHMP also decided that Zinnat should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).

The amended information to doctors and patients is available under the 'All documents' tab.

The European Commission issued a decision on 23 August 2012.

Name Language First published Last updated
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) BG = bălgarski 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) ES = español 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) CS = čeština 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) DA = dansk 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) DE = Deutsch 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) ET = eesti keel 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) EL = elliniká 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) EN = English 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) FR = français 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) IT = italiano 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) LV = latviešu valoda 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) LT = lietuvių kalba 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) HU = magyar 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) MT = Malti 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) NL = Nederlands 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) PL = polski 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) PT = português 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) RO = română 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SK = slovenčina 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SL = slovenščina 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) FI = suomi 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SV = svenska 25/05/2012 29/01/2013

Key facts

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

cefuroxime axetil

Associated namesCefuroxima Solasma, Cefuroxima Allen, Cefuroxima Duncan, Elobact, Nivador, Oraxim, Selan, Tilexim, Zinadol, Zipos, Zoref
ClassAnti-infectives
Reference numberEMEA/H/A-30/1157
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 Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) BG = bălgarski 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) ES = español 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) CS = čeština 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) DA = dansk 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) DE = Deutsch 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) ET = eesti keel 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) EL = elliniká 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) EN = English 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) FR = français 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) IT = italiano 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) LV = latviešu valoda 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) LT = lietuvių kalba 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) HU = magyar 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) MT = Malti 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) NL = Nederlands 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) PL = polski 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) PT = português 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) RO = română 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SK = slovenčina 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SL = slovenščina 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) FI = suomi 25/05/2012 29/01/2013
Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension) SV = svenska 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex I BG = bălgarski 29/01/2013  
Zinnat - Article-30 referral - Annex I ES = español 29/01/2013  
Zinnat - Article-30 referral - Annex I CS = čeština 29/01/2013  
Zinnat - Article-30 referral - Annex I DA = dansk 29/01/2013  
Zinnat - Article-30 referral - Annex I DE = Deutsch 29/01/2013  
Zinnat - Article-30 referral - Annex I ET = eesti keel 29/01/2013  
Zinnat - Article-30 referral - Annex I EL = elliniká 29/01/2013  
Zinnat - Article-30 referral - Annex I EN = English 29/01/2013  
Zinnat - Article-30 referral - Annex I FR = français 29/01/2013  
Zinnat - Article-30 referral - Annex I IT = italiano 29/01/2013  
Zinnat - Article-30 referral - Annex I LV = latviešu valoda 29/01/2013  
Zinnat - Article-30 referral - Annex I LT = lietuvių kalba 29/01/2013  
Zinnat - Article-30 referral - Annex I HU = magyar 29/01/2013  
Zinnat - Article-30 referral - Annex I MT = Malti 29/01/2013  
Zinnat - Article-30 referral - Annex I NL = Nederlands 29/01/2013  
Zinnat - Article-30 referral - Annex I PL = polski 29/01/2013  
Zinnat - Article-30 referral - Annex I PT = português 29/01/2013  
Zinnat - Article-30 referral - Annex I RO = română 29/01/2013  
Zinnat - Article-30 referral - Annex I SK = slovenčina 29/01/2013  
Zinnat - Article-30 referral - Annex I SL = slovenščina 29/01/2013  
Zinnat - Article-30 referral - Annex I FI = suomi 29/01/2013  
Zinnat - Article-30 referral - Annex I SV = svenska 29/01/2013  
Zinnat - Article-30 referral - Annex I IS = Islenska 29/01/2013  
Zinnat - Article-30 referral - Annex I NO = Norsk 29/01/2013  
Zinnat - Article-30 referral - Annex II BG = bălgarski 29/01/2013  
Zinnat - Article-30 referral - Annex II ES = español 29/01/2013  
Zinnat - Article-30 referral - Annex II CS = čeština 29/01/2013  
Zinnat - Article-30 referral - Annex II DA = dansk 29/01/2013  
Zinnat - Article-30 referral - Annex II DE = Deutsch 29/01/2013  
Zinnat - Article-30 referral - Annex II ET = eesti keel 29/01/2013  
Zinnat - Article-30 referral - Annex II EL = elliniká 29/01/2013  
Zinnat - Article-30 referral - Annex II EN = English 29/01/2013  
Zinnat - Article-30 referral - Annex II FR = français 29/01/2013  
Zinnat - Article-30 referral - Annex II IT = italiano 29/01/2013  
Zinnat - Article-30 referral - Annex II LV = latviešu valoda 29/01/2013  
Zinnat - Article-30 referral - Annex II LT = lietuvių kalba 29/01/2013  
Zinnat - Article-30 referral - Annex II HU = magyar 29/01/2013  
Zinnat - Article-30 referral - Annex II MT = Malti 29/01/2013  
Zinnat - Article-30 referral - Annex II NL = Nederlands 29/01/2013  
Zinnat - Article-30 referral - Annex II PL = polski 29/01/2013  
Zinnat - Article-30 referral - Annex II PT = português 29/01/2013  
Zinnat - Article-30 referral - Annex II RO = română 29/01/2013  
Zinnat - Article-30 referral - Annex II SK = slovenčina 29/01/2013  
Zinnat - Article-30 referral - Annex II SL = slovenščina 29/01/2013  
Zinnat - Article-30 referral - Annex II FI = suomi 29/01/2013  
Zinnat - Article-30 referral - Annex II SV = svenska 29/01/2013  
Zinnat - Article-30 referral - Annex III BG = bălgarski 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III ES = español 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III CS = čeština 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III DA = dansk 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III DE = Deutsch 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III ET = eesti keel 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III EL = elliniká 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III EN = English 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III FR = français 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III IT = italiano 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III LV = latviešu valoda 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III LT = lietuvių kalba 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III HU = magyar 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III MT = Malti 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III NL = Nederlands 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III PL = polski 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III PT = português 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III RO = română 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III SK = slovenčina 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III SL = slovenščina 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III FI = suomi 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III SV = svenska 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III IS = Islenska 25/05/2012 29/01/2013
Zinnat - Article-30 referral - Annex III NO = Norsk 25/05/2012 29/01/2013
Assessment report for Zinnat and associated names (English only) 29/01/2013  

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 Zinnat