Zinacef - referral

Current status

European Commission final decision

Overview

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

What is Zinacef?

Zinacef is an antibiotic used to treat certain bacterial infections, including pneumonia (infection of the lungs), urinary-tract infections (infections of the structures that carry urine), soft-tissue infections (infections of tissues just below the skin) and infections within the abdomen, as well as to prevent infections during surgery.

The active substance, cefuroxime sodium, 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.

Zinacef is marketed in all EU Member States (except Germany and Slovakia), as well as Iceland and Norway. It is also available under other trade names: Curocef, Curoxim, Curoxim Monovial, Curoxima, Curoxime, Zinnat, Zinocep and Zinocep Vena.

The company that markets these medicines is GlaxoSmithKline.

Why was Zinacef reviewed?

Zinacef 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.

Zinacef 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 Zinacef 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 Zinacef should no longer be used to treat severe ear, nose and throat infections as well as bone and joint infections 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 Zinacef should be used in adults and children from birth for the following conditions:

• community-acquired (acquired outside the hospital) pneumonia;
• acute exacerbations (flares-up) of chronic bronchitis;
• complicated urinary tract infections, including pyelonephritis (kidney infection);
• soft-tissue infections: cellulitis, erysipelas and wound infections;
• intra-abdominal infections;
• prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including Caesarean section).

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinacef in adults and children and in patients with reduced kidney and liver function. Zinacef should be given by injection into a vein over a period of 3 to 5 minutes, by infusion over 30 to 60 minutes, or by deep intramuscular injection, at different doses depending on the condition it is used to treat.

The CHMP also decided that Zinacef 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 10 September 2012.

Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion)

Adopted Reference Number: EMA/CHMP/339193/2012 Summary:

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

Key facts

About this medicine

• Approved name:
  Zinacef
• International non-proprietary name (INN) or common name:
  cefuroxime sodium
• Associated names:
  • Curocef
  • Curoxim
  • Curoxim Monovial
  • Curoxima
  • Curoxime
  • Zinnat
  • Zinocep
  • Zinocep Vena
• Class:
  Anti-infectives

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1158
• 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:
  10/09/2012

All documents

European Commission final decision

Zinacef - Article-30 referral - Annex I

Zinacef - Article-30 referral - Annex II

Assessment report for Zinacef and associated names

Adopted Reference Number: EMA/CHMP/633654/2012

Zinacef - Article-30 referral - Annex III

Adopted

Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion)

Adopted Reference Number: EMA/CHMP/339193/2012 Summary:

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