EMEA-001032-PIP01-10-M02

Key facts

Invented name
Opsumit
Active substance
Macitentan
Therapeutic area
Cardiovascular diseases
Decision number
P/0049/2016
PIP number
EMEA-001032-PIP01-10-M02
Pharmaceutical form(s)
  • Dispersible tablet
  • Film-coated tablet
Condition(s) / indication(s)
  • Treatment of idiopathic pulmonary fibrosis
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
Route(s) of administration
Oral use
Contact for public enquiries
Actelion Registration Ltd.

Tel.+41 61 565 65 65
E-mail:clinical-trials-disclosure@its.jnj.com

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

Decision

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