Paediatric-use marketing authorisation

Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years. Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees.[1]

In September 2011, the first drug was approved under this process. It was Buccolam, a buccal application form of midazolam for the treatment of seizures.[2][3]

References

"Questions and answers on the paediatric use marketing authorisation (PUMA)" (PDF). European Medicines Agency. 13 September 2011.
"Monthly Report" (PDF). Committee for Medicinal Products for Human Use (CHMP). 5 July 2011. p. 1.
PR Newswire (6 September 2011). "ViroPharma's Buccolam (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures".

This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.

[1] "Questions and answers on the paediatric use marketing authorisation (PUMA)" (PDF). European Medicines Agency. 13 September 2011.

[2] "Monthly Report" (PDF). Committee for Medicinal Products for Human Use (CHMP). 5 July 2011. p. 1.

[3] PR Newswire (6 September 2011). "ViroPharma's Buccolam (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures".