Displaying 241 - 260 of 773
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100316-PIP01-21
  • latozinemab
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100315-PIP01-21
  • Brensocatib
  • Treatment of non‐cystic fibrosis bronchiectasis
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100330-PIP01-21
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Other: Metabolic disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100330-PIP01-21 -M01 (update)
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
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-100448-PIP01-22
  • RUXOLITINIB PHOSPHATE
  • Treatment of vitiligo
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100037-PIP01-21-M01 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/disfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100037-PIP01-21-M02 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/dysfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100058-PIP01-21-M01 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100222-PIP01-21-M01 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100222-PIP01-21-M02 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100130-PIP01-21-M01 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100130-PIP01-21-M02 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100129-PIP01-21-M01 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/07/2022
MHRA-100143-PIP01-21-M01 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100143-PIP01-21-M02 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Vemlidy
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100117-PIP01-21-M01 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100117-PIP01-21-M02 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023