Zinnat - referral

Current status

European Commission final decision

Overview

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.

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)

AdoptedReference Number: EMA/CHMP/339191/2012 Rev.1Summary:

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).

Key facts

About this medicine

• Approved name:
  Zinnat
• International non-proprietary name (INN) or common name:
  cefuroxime axetil
• Associated names:
  • Cefuroxima Solasma
  • Cefuroxima Allen
  • Cefuroxima Duncan
  • Elobact
  • Nivador
  • Oraxim
  • Selan
  • Tilexim
  • Zinadol
  • Zipos
  • Zoref
• Class:
  Anti-infectives

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1157
• 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:
  23/08/2012

All documents

European Commission final decision

Zinnat - Article-30 referral - Annex I

Zinnat - Article-30 referral - Annex II

Assessment report for Zinnat and associated names

AdoptedReference Number: EMA/CHMP/633839/2012

Zinnat - Article-30 referral - Annex III

Adopted

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)

AdoptedReference Number: EMA/CHMP/339191/2012 Rev.1Summary:

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).

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.