Sialanar (320 micrograms/ml glycopyrronium) received a Paediatric Use Marketing Authorisation (PUMA) in September 2016 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 dropdown list for Healthcare Professionals)
PUMA is a dedicated marketing authorisation for medicinal products indicated exclusively for use in the paediatric population, or subsets thereof, with, if necessary, an age-appropriate formulation. It has been designed to promote paediatric development of already authorised products which are no longer covered by a supplementary protection certificate (SPC) or a patent qualifying for a SPC.
Proveca Ltd is a UK based pharmaceutical company established in 2010 by Dr Helen Shaw and Dr Simon Bryson, to bring much needed licensed medicines to children throughout Europe. Currently, 50-90% of the medicines taken by children are in the wrong format and/or are not licensed for paediatric use.
Date of last revision of page: March 2019