EMEA-000671-PIP01-09-M10

Table of contents

Key facts

Invented name
Revatio
Active substance
sildenafil
Therapeutic area
Other
Decision number
P/0016/2019
PIP number
EMEA-000671-PIP01-09-M10
Pharmaceutical form(s)
  • Film-coated tablet
  • Powder for oral solution
  • Solution for injection
Condition(s) / indication(s)
Treatment of pulmonary arterial hypertension
Route(s) of administration
  • Oral use
  • Intravenous use
Contact for public enquiries
Pfizer Europe MA EEIG

Tel. +44 (0)1304 646 607
E-mail: pip_enquiries@pfizer.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000671-PIP01-09-M10
Compliance opinion date
20/09/2019
Compliance outcome
positive

Decision

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