EMEA-000339-PIP02-09-M03

Key facts

Invented name
Baraclude
Active substance
Entecavir
Therapeutic area
Infectious diseases
Decision number
P/0125/2014
PIP number
EMEA-000339-PIP02-09-M03
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
Condition(s) / indication(s)
Treatment of chronic hepatitis B
Route(s) of administration
Oral use
Contact for public enquiries
Bristol-Myers Squibb Pharma EEIG
United Kingdom
E-mail: medinfo.emea@bms.com
Tel. +44 (0)189 552 3686
ax +44 (0)189 552 3788
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000339-PIP02-09-M03
Compliance opinion date
20/06/2014
Compliance outcome
positive

Decision

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