EMEA-001584-PIP01-13-M04

Key facts

Invented name
Vemlidy
Active substance
Tenofovir alafenamide (as fumarate)
Therapeutic area
Infectious diseases
Decision number
P/0133/2019
PIP number
EMEA-001584-PIP01-13-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate tablet
  • Age appropriate non-tablet formulation
Condition(s) / indication(s)
Treatment of chronic viral hepatitis B
Route(s) of administration
Oral use
Contact for public enquiries
Gilead Sciences International Ltd. 

Tel. +44 (0)1223 897 300 
E-mail: regulatory.pip@gilead.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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