Targocid and associated names - referral

Current status

European Commission final decision

Overview

On 30 May 2013, the European Medicines Agency completed a review of Targocid. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Targocid in the European Union (EU).

What is Targocid?

Targocid is an antibiotic that contains the active substance teicoplanin. It is used by injection or infusion (drip) to treat serious bacterial infections. It can also be given by mouth to treat diarrhoea and colitis (inflammation of the bowel) caused by infection with a bacterium called Clostridum difficile.

The active substance, teicoplanin, is one of a group of antibiotics known as glycopeptides. It works by attaching to the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them.

Targocid is also available in the EU under other trade names: Targosid, Teicomid.

The company that markets these medicines is Sanofi-Aventis.

Why was Targocid reviewed?

Targocid 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.

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

On 17 November 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Targocid 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 Targocid should be used by injection or infusion to treat the following infections in adults and children:

• complicated infections of the skin and soft tissues;
• bone and joint infections;
• hospital- or community-acquired pneumonia (infection of the lung caught in or outside hospital);
• complicated urinary-tract infections (infections of the structures that carry urine);
• endocarditis (infection of the inner lining of the heart – most commonly the valves of the heart);
• peritonitis (inflammation of the peritoneum, the membrane lining the abdominal cavity) in patients undergoing 'continuous ambulatory peritoneal dialysis';
• bacteraemia (bacterial infection in the blood) resulting from any of the above.

The Committee also agreed that Targocid could be taken by mouth to treat diarrhoea and colitis (inflammation of the bowel) associated with infection by bacteria called Clostridium difficile.

The Committee did not recommend the use of Targocid to prevent infections.

Since Targocid is only effective against certain kinds of bacteria, it should be used in combination with other antibiotics if necessary, and in line with official recommendations on antibiotic use.

4.2 Posology and method of administration

The Committee also agreed on specific dose ranges for adults and children (from birth) for the various infections. This includes initial doses as well as doses for maintenance treatment and doses to be used in patients with reduced kidney function. For certain types of infections, a higher initial dose of 12 mg per kilogram body weight twice daily (used in a few member states of the EU), was agreed by the CHMP. The amount of the medicine in the blood should be measured to ensure that effective levels have been reached.

4.4 Special warnings and precautions for use

The CHMP agreed to harmonise the warnings and precautions for the medicine. These include the fact that Targocid may cause serious life-threatening hypersensitivity (allergic) reactions which require immediate cessation of the medicine and emergency treatment. Care is needed in patients who are allergic to another antibiotic, vancomycin, as they may be at greater risk. Other possible effects for which treatment may need to be stopped or altered include infusion-related reactions called 'red-man syndrome', severe skin rashes, thrombocytopenia (low blood levels of cells called platelets that are important for clotting), kidney damage, and effects on hearing. Regular blood and kidney function tests and monitoring of any effects on hearing are recommended during treatment. Patients should be particularly carefully monitored if given higher initial doses (12 mg per kilogram body weight twice daily).

Targocid should be used to treat severe infections where standard antibiotic treatment is not suitable. It is only effective against certain types of bacteria (called Gram-positive bacteria) and should be used in combination with other antibiotics if necessary. Prolonged use may encourage the growth of bacteria against which it is not active.

Other changes

The Committee also harmonised other sections of the SmPC, including sections 4.3 (contra-indications), 4.5 (interactions with other medicines), 4.6 (use in pregnancy and breast feeding), 4.8 (undesirable effects), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties) and 5.3 (preclinical safety data).

The Committee asked the company that markets the medicine to submit a risk management plan for the safe use of Targocid, including a study to monitor the safety of the increased initial dose recommendations (12 mg per kilogram body weight twice daily).

The amended information to doctors and patients is available in Annex III.

The European Commission issued a decision on 12 September 2013.

Questions and answers on Targocid and associated names (teicoplanin, powder or powder and solvent for solution for injection, infusion or oral solution, 100, 200 and 400 mg)

Reference Number: EMA/319080/2013

Key facts

About this medicine

• Approved name:
  Targocid and associated names
• International non-proprietary name (INN) or common name:
  teicoplanin
• Associated names:
  • Targocid
  • Teicomid
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1301
• 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:
  30/05/2013
• EC decision date:
  12/09/2013

All documents

Opinion provided by Committee for Medicinal Products for human Use

Targocid Article-30 referral - Annex III

Questions and answers on Targocid and associated names (teicoplanin, powder or powder and solvent for solution for injection, infusion or oral solution, 100, 200 and 400 mg)

Reference Number: EMA/319080/2013

European Commission final decision

Targocid Article-30 referral - Annex I

Targocid Article-30 referral - Annex II

Targocid Article-30 referral - Annex IV

Targocid Article-30 referral - CHMP assessment report

Adopted Reference Number: EMEA/CHMP/269452/2008

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.