This section is only for Healthcare Professionals and relates to the medical products provided by Proveca. Proveca also invests in the provision of educational items which are listed on the drop-down menu, these can be given to carers and patients by Healthcare Professionals.
(320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide)
Sialanar® 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)
The paediatric-use marketing authorisation (PUMA) is a dedicated marketing authorisation covering the indication(s) and appropriate formulation(s) for medicines developed exclusively for use in the paediatric population.
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)
Created May 2020