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Displaying 1 - 10 of 10
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101058-PIP01-23
  • SIROLIMUS
  • Treatment of Tuberous Sclerosis
  • Pascomer
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 30/01/2024
MHRA-100885-PIP01-23
  • Iptacopan
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Not available at present; Product code: LNP023
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 19/12/2023
MHRA-100787-PIP01-22
  • Repotrectinib
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
  • Not available at present
  • Oncology
  • Other: Not Applicable
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 19/12/2023
MHRA-100741-PIP01-22
  • CRISANTASPASE
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
  • Enrylaze
  • Rylaze
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 19/12/2023
MHRA-100706-PIP01-22
  • METHYLPHENIDATE HYDROCHLORIDE
  • Treatment of attention-deficit hyperactivity disorder
  • Not available at present
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 30/06/2023
MHRA-100605-PIP01-22
  • sparsentan
  • Treatment of immunoglobulin A nephropathy
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 25/05/2023
MHRA-100445-PIP01-22
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 07/12/2022
MHRA-100312-PIP01-21
  • Ritlectinib
  • Treatment of alopecia areata
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 29/07/2022
MHRA-100068-PIP01-21
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio; Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 17/03/2022
MHRA-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 03/11/2021