Paediatric-Use Marketing Authorisation (PUMA) Medicine By Proveca

In 2007, European Paediatric Regulation came into force to improve the health of children by increasing research, development and authorisation of medicines based on specific paediatric experience.1 The Paediatric Regulation introduced the Paediatric-Use Marketing Authorisation (PUMA), a dedicated marketing authorisation for medicines developed exclusively for use in the paediatric population. As part of the pathway to PUMA, a Paediatric Investigation Plan (PIP) must first be agreed by the European Medicine Agency’s Paediatric Committee.

Proveca Ltd specialises in identifying, developing and facilitating the licensing of off-patent medicines for children where priority healthcare needs exist.

Proveca worked with the European Medicine Agency’s Paediatric Committee to gain a PUMA in September 2016 for Sialanar® (400mcg/ml glycopyrronium bromide) a glycopyrronium oral solution for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children aged 3 years and older with chronic neurological disorders. (Sialanar® Summary of Product Characteristics can be found on the Sialanar® page)

The PUMA was introduced by the Paediatric Regulation for medicines that are:

  • already authorised;
  • no longer covered by a supplementary protection certificate (SPC) or a patent that qualifies as a SPC;
  • to be exclusively developed for use in children.

Sialanar® was the third so-called PUMA drug in the EU

  • 1st PUMA: Buccolam (Shire)
  • 2nd PUMA: Hemangiol (Pierre Fabre)
  • 3rd PUMA: Sialanar® (Proveca)
  • 4th PUMA: Alkindi (Diurnal)
  • 5th PUMA: Kigabeq (Lundbeck)
  • 6th PUMA: Slenyto (Neurim)

(1) European Medicines Agency. Better medicines for children. Available at: https://www.ema.europa.eu/en/documents/leaflet/better-medicines-children_en.pdf

Reviewed November 2021