Sialanar (glycopyrronium bromide)
- Region
- 🇪🇺 EU
- Active substance
- glycopyrronium bromide
- Company
- Proveca Pharma Limited
- Status
- Authorised
- Therapeutic area
- Sialorrhea
- EU approval
- Thu 15 Sep 2016
- Application
- EMEA/H/C/003883
- ATC
- A03AB02
- Official record
- www.ema.europa.eu
Indication
Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.