Teicoplanin Hospira - referral

Current status

European Commission final decision

Overview

On 25 June 2009, the European Medicines Agency (EMEA) completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Teicoplanin Hospira. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Teicoplanin Hospira do not outweigh its risks, and the marketing authorisation cannot be granted in Germany and in other Member States of the EU (Austria, Ireland, Italy, Portugal, Spain and the United Kingdom).

The company that makes Teicoplanin Hospira, Hospira UK Limited, requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 22 October 2009.

What is Teicoplanin Hospira?

Teicoplanin Hospira is an antibiotic. It is use to treat patients with serious infections due to Gram-positive bacteria. Gram-positive bacteria include bacteria such as staphylocci (Staphylococcus aureus), streptococci (Streptococcus pneumoniae), Listeria, Clostridium difficile. These bacteria can cause skin infections, lung infections, joint and bone infections, heart infections or infections of the urinary tract (structures that carry urine). Teicoplanin Hospira can only be used in patients who cannot receive penicillin or cephalosporins antibiotics, or if these antibiotics have stopped working or the infection is due to a Staphylococcus that is resistant to other antibiotics.

Teicoplanin Hospira can also be used to prevent infections in patients undergoing surgery of the bones, joint or blood vessels.
The active substance in Teicoplanin Hospira, teicoplanin, is an antibiotic that belongs to the group 'glycopeptides'. It works by stopping the bacteria making their cell walls and by disrupting their cell membranes. Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment. By disrupting this barrier, teicoplanin kills the bacteria that are causing the infection.

Teicoplanin Hospira is a generic medicine based on a 'reference medicine' authorised in Germany (Targocid 400 mg).

Why was Teicoplanin Hospira reviewed?

Hospira UK Limited submitted Teicoplanin Hospira to the German Regulatory Agency for a decentralised procedure. This is a procedure when one Member State (the 'reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance Austria, Ireland, Italy, Portugal, Spain and the United Kingdom).

However, the Member States were not able to reach an agreement and the German Regulatory Agency referred the matter to the CHMP for arbitration on 8 October 2008.

The grounds for the referral were concerns from Ireland and the United Kingdom that Teicoplanin Hospira had not been shown to be bioequivalent to Targocid. Medicines are bioequivalent when they produce the same levels of the active substance in the body.

There were also concerns that the composition of the teicoplanin in Teicoplanin Hospira was different to that in Targocid, with a potential impact on the effectiveness of the medicine. This is because teicoplanin in Teicoplanin Hospira is made by fermentation, using a bacterium called Actinoplanes to produce the antibiotic. When an antibiotic is produced using a natural source, as in this instance, there can be some differences in the composition of the finished product.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Teicoplanin Hospira do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States. The CHMP opinion was confirmed after re-examination.

Questions and answers on the referral for Teicoplanin Hospira powder and solvent for injection containing 200 or 400 mg teicoplanin

AdoptedReference Number: EMA/CHMP/77992/2010

Key facts

About this medicine

• Approved name:
  Teicoplanin Hospira
• International non-proprietary name (INN) or common name:
  teicoplanin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1084
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  22/10/2009
• EC decision date:
  29/01/2010

All documents

Teicoplanin hospira - Article 29 referral - Annex I, II

Questions and answers on the referral for Teicoplanin Hospira powder and solvent for injection containing 200 or 400 mg teicoplanin

AdoptedReference Number: EMA/CHMP/77992/2010

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.