EMEA-000425-PIP02-10-M04

Key facts

Invented name
Tracleer
Active substance
Bosentan
Therapeutic area
Pneumology-allergology
Decision number
P/0090/2013
PIP number
EMEA-000425-PIP02-10-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • dispersible tablet
Condition(s) / indication(s)
  • Treatment of interstitial pulmonary fibrosis
  • Treatment of systemic sclerosis
  • Treatment of pulmonary arterial hypertension (PAH)
Route(s) of administration
Oral use
Contact for public enquiries
Actelion Registration Ltd
Tel. +41 615656565
E-mail: clinical-trials-disclosure@its.jnj.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000425-PIP02-10-M04
Compliance opinion date
21/03/2014
Compliance outcome
positive

Decision

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