EMEA-001961-PIP01-16

Key facts

Active substance
  • Macitentan
  • tadalafil
Therapeutic area
Cardiovascular diseases
Decision number
P/0243/2016
PIP number
EMEA-001961-PIP01-16
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of pulmonary arterial hypertension
Route(s) of administration
Oral use
Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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