Tienam - referral

Current status

European Commission final decision

Overview

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

What is Tienam?

Tienam is an antibiotic used in complicated infections, generally in hospital. It has been used to treat infections of the lungs, the urinary tract (structures that carry urine), the abdomen, skin and the reproductive system. It can also be used in patients whose immune system is weakened when they have a fever.

Tienam contains two active substances: imipenem, which is an antibiotic belonging to the carbapenem family, and cilastatin, which is a 'dehydropeptidase inhibitor'. When Tienam is absorbed in the body, the imipenem component kills the bacteria that are causing the infection, while the cilastatin component blocks the dehypropeptidase enzyme in the kidney that normally breaks down imipenem. As a result, the antibiotic stays in the body and can work for longer.

The medicine is available in all EU Member States under the trade name Tienam, as well under other trade names: Conet, Imipem, Primaxin, Tenacid and Zienam. The company that markets these medicines is Merck, Sharp & Dohme.

Why was Tienam reviewed?

A company applied in the Netherlands for a generic version of Tienam in a decentralised procedure involving 16 Member States. During a decentralised procedure, the application submitted by the company is assessed by one Member State (the 'reference Member State', in this instance the Netherlands), 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'). While this process was ongoing, divergences across Member States were noted in the way Tienam can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets. The concerned Member States could not agree on the indications and on the recommendation for children under three years of age.

On 18 May 2009, the Dutch medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Tienam 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 on the following indications:

• complicated intra-abdominal infections,
• severe pneumonia including hospital and ventilator-associated pneumonia,
• intra- and post-partum infections,
• complicated urinary tract infections,
• complicated skin and soft-tissue infections,
• use for fever in neutropenic patients when infection is suspected,
• treatment of bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above.

The CHMP recommended that Tienam should not be used in some indications, such as meningitis, osteomyelitis (infection of the bones) and lung infection in cystic fibrosis patients. The CHMP also removed the use of Tienam in the prevention of infections.

4.2 Posology and method of administration

The CHMP harmonised the posology (the dose and frequency of dosing) in adults. For children, the CHMP recommended a harmonised dosage in children over one year of age, and made no dosage recommendations for children under one year of age because of a lack of data for this age group.

Other changes

The Committee also recommended harmonised wordings in other areas such as contra-indications, warnings and side effects.

The European Commission issued a decision on this opinion on 10 March 2011.

Questions and answers on Tienam and associated names (imipenem/cilastatin for infusion 500 mg/500 mg)

Reference Number: EMEA/H/A-30/001187

Key facts

About this medicine

• Approved name:
  Tienam
• International non-proprietary name (INN) or common name:
  • imipenem
  • cilastatin
• Associated names:
  • Conet
  • Imipem
  • Primaxin
  • Tenacid
  • Zienam

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/001187
• 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:
  16/12/2010
• EC decision date:
  10/03/2011

All documents

Tienam - Article 30 Referral - Annex I

Tienam - Article 30 Referral - Annex II

Assessment report for Tienam and associated names

Adopted Reference Number: EMA/513740/2011

Tienam - Article 30 Referral - Annex III

Questions and answers on Tienam and associated names (imipenem/cilastatin for infusion 500 mg/500 mg)

Reference Number: EMEA/H/A-30/001187

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.