EMEA-000409-PIP01-08-M06

Key facts

Invented name
Tivicay
Active substance
Dolutegravir (DTG)
Therapeutic area
Infectious diseases
Decision number
P/0267/2021
PIP number
EMEA-000409-PIP01-08-M06
Pharmaceutical form(s)
  • Age appropriate formulation for oral use
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
Oral use
Contact for public enquiries
ViiV Healthcare UK Ltd.

United Kingdom
E-mail: eu.paediatric-plans@gsk.com
Tel. +1 4388998201
Fax +44 (0)20 8990 3511

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000409-PIP01-08-M06
Compliance opinion date
15/10/2021
Compliance outcome
positive

Decision

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