EMEA-002398-PIP01-18

Key facts

Active substance
N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
Therapeutic area
Pneumology-allergology
Decision number
P/0191/2019
PIP number
EMEA-002398-PIP01-18
Pharmaceutical form(s)
Oral use
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
  • Capsule, hard
  • Age-appropriate oral dosage form
Contact for public enquiries
SFL Regulatory Services GmbH

Tel.  +41 613667160
E-mail: j.gaudias@sfl-services.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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