Tazocin - referral

Current status

European Commission final decision

Overview

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

What is Tazocin?

Tazocin is a medicine that contains the active substances piperacillin and tazobactam. It is used to treat a wide range of bacterial infections.

Piperacillin is an antibiotic that belongs to the group 'beta-lactams'. It works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Tazobactam blocks the action of bacterial enzymes called beta-lactamases. Beta-lactamases break down beta-lactam antibiotics such as piperacillin, making the bacteria resistant to these medicines. By blocking the action of beta-lactamases, tazobactam stops bacteria from being resistant to piperacillin, thereby making piperacillin more effective at killing them.

Tazocin is also available in the EU under other trade names: Tazobac, Tazocel, Tazocilline and Tazonam.

The company that markets these medicines is Pfizer.

Why was Tazocin reviewed?

Tazocin 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.

Tazocin was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 12 June 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tazocin 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 Tazocin should be used to treat the following infections in adults and adolescents:

• severe pneumonia (infection of the lungs), including infections acquired in hospital or by patients on a mechanical ventilator
• complicated urinary tract infections, including pyelonephritis (kidney infection)
• complicated intra-abdominal infections (infections within the abdomen)
• complicated skin and soft tissue infections, including diabetic foot infections.

Tazocin can also be used in adults to treat bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above.

Tazocin can be used to treat complicated intra-abdominal infections in children aged from two to 12 years.

Tazocin may also be used to manage children, adolescents and adults with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection.

4.2 Posology and method of administration

In adults and adolescents the usual dose is 4 g piperacillin /0.5 g tazobactam given every eight hours. For severe pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin /0.5 g tazobactam given every six hours.

The dose for children is 80 mg piperacillin /10 mg tazobactam per kilogram body weight every six hours for neutropenic children and 100 mg piperacillin /12.5 mg tazobactam per kg body weight every eight hours for children with complicated intra-abdominal infections.

Other sections

The Committee also harmonised other sections of the SmPC including the sections on contraindications, special warnings and pregnancy and lactation.

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

Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)

Reference Number: EMA/656918/2010

Key facts

About this medicine

• Approved name:
  Tazocin
• International non-proprietary name (INN) or common name:
  • piperacillin
  • tazobactam
• Associated names:
  • Tazobac
  • Tazocel
  • Tazonam

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001149
• 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:
  21/10/2010
• EC decision date:
  21/02/2011

All documents

Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)

Reference Number: EMA/656918/2010

European Commission final decision

Tazocin - Article-30 referral - Assessment report

Adopted

Tazocin - Article-30 referral - Annex I

Tazocin - Article-30 referral - Annex II

Tazocin - Article-30 referral - Annex III

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.