EMEA-001366-PIP01-12-M02 - paediatric investigation plan

Glycopyrronium bromide
PIPHuman

Key facts

Invented name
Sialanar
Active Substance
Glycopyrronium bromide
Therapeutic area
Neurology
Decision number
P/0240/2014
PIP number
EMEA-001366-PIP01-12-M02
Pharmaceutical form(s)
Oral liquid
Condition(s) / indication(s)
Treatment of sialorrhoea
Route(s) of administration
Oral use
Contact for public enquiries

Proveca Limited
Tel. +44 7913048665
E-mail: simon@proveca.co.uk

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001366-PIP01-12-M02
Compliance opinion date
Compliance outcome
Positive

Decision

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