MHRA-100062-PIP01-21

Key Facts

Active Substance
  • (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate
  • TEZACAFTOR
  • DEUTIVACAFTOR
Invented Name
Not yet available
PIP Number MHRA-100062-PIP01-21
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of Cystic Fibrosis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
18/06/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100062-PIP01-21-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,1.pdf
Published Date 14/04/2026