Glycopyrrolate - Proveca

Drug Profile

Glycopyrrolate - Proveca

Alternative Names: Sialanar

Latest Information Update: 30 May 2018

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At a glance

  • Originator Proveca
  • Class Antiasthmatics; Antispasmodics; Pyrrolidines; Quaternary ammonium compounds; Skin disorder therapies; Small molecules
  • Mechanism of Action Muscarinic receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Sialorrhoea

Most Recent Events

  • 09 Jun 2017 Glycopyrrolate (Sialanar®, 320 µg/ml) is available on a Named Patient Access Programme for the treatment of Sialorrhoea in World excluding Europe and USA
  • 21 Jul 2016 The Committee for Medicinal Products for Human Use recommends approval of glycopyrronium bromide for Sialorrhoea in European Union
  • 26 May 2016 Proveca requests a re-examination of the Committee for Medicinal Products for Human Use' April 2016 recommendation-refusing approval of glycopyrronium bromide for Sialorrhoea
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