Meronem - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of Meronem and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Meronem and associated names in the European Union (EU).
The review was carried out under an 'Article 30' referral¹.

The European Commission issued a decision on 15 October 2009.

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¹ Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States

What is Meronem?

Meronem is a powder that is made up into a solution for injection or infusion. It contains the active substance meropenem.

Meronem is used to treat various bacterial infections including infections of the lungs, urinary tract (structures that carry urine), the abdomen, skin, the female reproductive system and brain.

The active substance in Meronem, meropenem, is an antibiotic that belongs to the group 'carbapenems'. It works by attaching to certain types of protein on the surface of the bacteria cells. This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.

It is also available in the EU under the trade names Optinem and Merrem. The company that markets Meronem is AstraZeneca.

Why was Meronem reviewed?

Meronem and associated names are 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 (SPCs), labelling and package leaflets in the countries where the product is marketed. Meronem has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMD(h)).

On 1 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Meronem and associated names 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 SPCs, labelling and package leaflets should be harmonised across the EU.

4.1 Therapeutic indications
At the start of the referral, some of the indications such as skin and skin tissue infections and urinary tract infections or infections of the female reproductive system were not approved in all Member States. Also, not all Member States had authorised the medicine for use in children.
The CHMP agreed on the following diseases for which the medicine may be used:

• pneumonia (infection of the lungs);
• broncho-pulmonary infections in patients with cystic fibrosis;
• complicated urinary tract infections;
• complicated infections in the abdomen;
• intra- and post-partum infections (infections during and after childbirth);
• complicated skin and soft tissue infections;
• acute bacterial meningitis (inflammation of the membranes that surround the brain and spine).

The Committee noted that for most indications Meronem should be used for children above three months of age, but that doctors should retain the option of treating younger children.
Meronem may also be used in patients with neutropenic fever (fever associated with low levels of neutrophils, a type of white blood cell) that is suspected to be caused by bacterial infection.

4.2 Posology and method of administration
Because the recommended dose for both adults and children differed among Member States, the CHMP recommended harmonised dosage schedules:

• for pneumonia, complicated urinary tract infections, complicated intra-abdominal infections, intra- and post-partum infections and complicated skin and soft tissue infections, the recommended dose in adults and children weighing more than 50 kg should 500 mg or 1 g every eight hours, while children aged from three months to 11 years and those weighing less than 50 kg should be given 10 or 20 mg/kg every eight hours.
• for broncho-pulmonary infections in cystic fibrosis and acute bacterial meningitis, the CHMP recommended a dose of 2 g every eight hours in adults and children weighing over 50 kg, and 40 mg/kg every eight hours in children aged from three months to 11 years and those weighing less than 50 kg.]

4.3 Contra-indications
At the start of the referral, some Member States did not include hypersensitivity (allergy) to carbapenems, penicillins or other beta-lactam antibiotics as contra-indications (situations where the medicine must not be used) and some Member States included hypersensitivity to excipients (other ingredients in the medicine).
The CHMP agreed on a harmonised list of contra-indications. The Committee recommended that Meronem should not be used in patients who are hypersensitive to any carbapenem medicine or in patients who have severe hypersensitivity to any type of beta-lactam anti-bacterial medicines such as penicillins or cephalosporins.

Other changes
The CHMP harmonised the SPC section on special warnings and retained warnings about convulsions and hepatic reactions.
The Committee also harmonised the SPC section on interactions with other medicines. The new wording mentions that medicines containing valproic acid should be avoided when taking Meronem.

The amended information to doctors and patients is available under the "All documents" tabs.

Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g - Final

Adopted Reference Number: EMEA/CHMP/746085/2009

Key facts

About this medicine

• Approved name:
  Meronem
• International non-proprietary name (INN) or common name:
  meropenem

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-30/1003
• 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:
  23/07/2009
• EC decision date:
  15/10/2009

All documents

Meronem - Article 30 referral - Annex I, II, III

Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g

Adopted Reference Number: EMEA/CHMP/466849/2009

Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g - Final

Adopted Reference Number: EMEA/CHMP/746085/2009

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.