EMEA-001640-PIP01-14-M06

Key facts

Invented name
Symkevi
Active substance
  • tezacaftor
  • ivacaftor
Therapeutic area
Pneumology-allergology
Decision number
P/0193/2020
PIP number
EMEA-001640-PIP01-14-M06
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of cystic fibrosis
Route(s) of administration
Oral use
Contact for public enquiries
Vertex Pharamceuticals (Europe) Ltd.

Tel. +1 8776348789
E-mail: medicalinfo@vrtx.com

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

Decision

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