EMEA-000440-PIP02-11-M05

Key facts

Invented name
Circadin
Active substance
melatonin
Therapeutic area
Neurology
Decision number
P/0089/2017
PIP number
EMEA-000440-PIP02-11-M05
Pharmaceutical form(s)
  • Prolonged-release tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of insomnia
Route(s) of administration
Oral use
Contact for public enquiries
RAD Neurim Pharmaceuticals EEC Ltd
United Kingdom
E-mail: talin@neurim.com
Tel. +972 37684902
Fax +972 36494568
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-000440-PIP02-11-M05
Compliance opinion date
21/04/2017
Compliance outcome
positive

Decision

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