EMEA-000636-PIP01-09-M07

Key facts

Invented name
Dificlir
Active substance
fidaxomicin
Therapeutic area
Infectious diseases
Decision number
P/0062/2018
PIP number
EMEA-000636-PIP01-09-M07
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules for oral suspension
Condition(s) / indication(s)
Treatment of enterocolitis caused by Clostridium difficile
Route(s) of administration
Oral use
Contact for public enquiries
Astellas Pharma Europe B.V.
Tel. +31 7154 55878
E-mail: contact@nl.astellas.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000636-PIP01-09-M07
Compliance opinion date
16/11/2018
Compliance outcome
positive

Decision

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