EMEA-000279-PIP01-08-M05

Key facts

Invented name
Isentress
Active substance
Raltegravir
Therapeutic area
Infectious diseases
Decision number
P/0155/2016
PIP number
EMEA-000279-PIP01-08-M05
Pharmaceutical form(s)
  • Film-coated tablet
  • Chewable tablet
  • Granules for oral suspension
Condition(s) / indication(s)
Treatment of human-immunodeficiency-virus (HIV-1) infection
Route(s) of administration
Oral use
Contact for public enquiries
Merck Sharp & Dohme (Europe) Inc.
Belgium
Tel.: +33180464738
E-mail: pip.information@merck.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000279-PIP01-08-M05
Compliance opinion date
19/06/2017
Compliance outcome
positive

Decision

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