EMEA-003052-PIP01-21 - paediatric investigation plan

(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 (VX-121/ TEZ/D-IVA)

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 (VX-121/ TEZ/D-IVA)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0071/2022
• PIP number:
  EMEA-003052-PIP01-21
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of cystic fibrosis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/11/2022

Decision

P/0071/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy).....(EMEA-003052-PIP01-21)

AdoptedReference Number: EMA/71025/2022