EMEA-000018-PIP01-07-M14

Key facts

Invented name
Palexia and associated names; Yantil and associated names; Tapentadol and associated names
Active substance
Tapentadol (hydrochloride)
Therapeutic area
Pain
Decision number
P/0355/2017
PIP number
EMEA-000018-PIP01-07-M14
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
  • Solution for injection/infusion
Condition(s) / indication(s)
Treatment of acute pain
Route(s) of administration
  • Oral use
  • Intravenous use
Contact for public enquiries
Grünenthal GmbH
Tel.: +49 2415690
E-mail: pediatrics@grunenthal.com 
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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