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.
Frost Pharma (Formerly Anthrop Pharma) is the local representative of Sialanar, within the Nordic region.
Anthrop Pharmaceuticals AB , based in Danderyd, Sweden, is specialized in the introduction, distribution and marketing of niche pharmaceuticals and hospital injectables in the Nordic region. Our main therapeutic areas are neurology, intensive care, anaesthesia, cystic fibrosis, gastroenterology and pain management.
Date of last revision of page: March 2019