Paediatric-use marketing authorisation
Encyclopedia
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, PUMA approved drugs are patent protected for a longer period of time, and are partially exempt from fees.
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.
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(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
European Economic Area
The European Economic Area was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association and the European Community, later the European Union . Specifically, it allows Iceland, Liechtenstein and Norway to participate in the EU's Internal...
(the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
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, PUMA approved drugs are patent protected for a longer period of time, and are partially exempt from fees.
In September 2011, the first drug was approved under this process. It was Buccolam, a buccal
Buccal
Buccal may refer to:* Mouth, a body cavity** Specifically the cheek* Buccal artery...
application form of midazolam
Midazolam
Midazolam is a short-acting drug in the benzodiazepine class developed by Hoffmann-La Roche in the 1970s. The drug is used for treatment of acute seizures, moderate to severe insomnia, and for inducing sedation and amnesia before medical procedures. It possesses profoundly potent anxiolytic,...
for the treatment of seizures.