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Press release: A big step forward for better children’s medicines

Press release

Date: 7 September 2011
Time: 12:00
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

The first ever children’s medicine to hold a new paediatric use marketing authorisation (PUMA) has been granted by the European Commission.

The medicine, Buccolam, is now specifically licensed for children aged three months to 18 years to treat severe convulsions and epileptic seizures.

The news is a landmark in the Medicines and Healthcare products Regulatory Agency's (MHRA’s) ongoing campaign to improve the quality, safety and efficacy of children’s medicines available in the UK.

The MHRA has been advocating the increased availability of specific children’s-only medicines for several years in recognition that many adult medicines are offered to children in cut-down doses.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine, said: “This is excellent news for children in Europe who suffer from these serious convulsions.

“Children’s-only medicines are of great benefit as they provide the right dose in the right form for kids.

“They are not simply ‘small adults’ and they respond differently to medication. Children should have access to medicines that have been especially designed for them.

“We hope today’s announcement and the introduction of the first PUMA will lead to many more children’s only medicines being made available in the UK.”

The MHRA is committed to continuing this good work and encouraging the development of children’s-only medicines for other conditions.

Notes to Editor

  1. The European Commission granted the first paediatric-use marketing authorisation (PUMA) for the medicine Buccolam (midazolam for buccal administration), from ViroPharma SPRL (external linK), intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of three months to 18 years.
  2. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) have given a positive opinion on this product on 23 June 2011. For further information please refer to the European Medicines Agency June 2011 press release (external link).
  3. The MHRA played a pivotal role in the assessment process for Buccolam in order to determine its suitability to treat severe convulsions and epileptic seizures. This has led to the first ever licence of its type being granted by the European Commission on 5 September 2011. The product has been authorised for use in any European Member State. It is expected that the product will be available in the UK from early October 2011.
  4. A paediatric use marketing authorisation (PUMA) is a new type of licence introduced by the European Paediatric Regulation. It is designed to encourage the development of older medicines, no longer covered by a patent, specifically for use in children. It is supported by an agreed paediatric investigation plan and when granted, it gives the product the same data and market exclusivity as a completely new medicine. PUMAs may be granted by national licensing authorities or, as in this case, by the European Commission for a Europe-wide authorisation.
  5. The European Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years, ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately improving the availability of information on the use of medicines for children.
  6. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults. The European Paediatric Regulation dramatically changed the regulatory environment for paediatric medicines in Europe.
  7. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
Page last modified: 07 September 2011