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Displaying 21 - 40 of 828
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100188-PIP01-21-M04 (update)
  • lebrikizumab
  • Treatment of atopic dermatitis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101991-PIP01-25
  • TAFASITAMAB
  • Treatment of mature B-cell neoplasms excluding diffuse large B-cell lymphoma
  • MINJUVI
  • MINJUVI
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101256-PIP01-23-M02 (update)
  • RISANKIZUMAB
  • Treatment of ulcerative colitis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102088-PIP01-25
  • Erdafitinib
  • Treatment of malignant neoplasms of the bladder
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101994-PIP01-25
  • dorocubicel / allogeneic umbilical cord-derived CD34- cells, non-expanded
  • Treatment of haematological malignancies requiring allogeneic haematopoietic stem cell transplantation
  • Zemcelpro
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101964-PIP01-25
  • Orforglipron
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101853-PIP01-25
  • GSK4532990
  • Treatment of alcoholic liver disease
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101802-PIP01-25
  • Recombinant human tissue nonspecific alkaline phosphatase (TNSALP) fragment crystallizable (Fc) deca aspartate fusion protein
  • Treatment of hypophosphatasia
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100242-PIP01-21-M01 (update)
  • Respiratory syncytial virus vaccine (bivalent, recombinant)
  • Respiratory syncytial virus stabilised prefusion f subunit vaccine (RSVpreF)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus.
  • Abrysvo powder and solvent for solution for injection
  • Abrysvo powder and solvent for solution for injection
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100100-PIP01-21-M01 (update)
  • Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein
  • (ER 004)
  • Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)
  • Other: Congenital, familial and genetic disorders. Skin and subcutaneous tissue disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101972-PIP01-25
  • Zimberelimab
  • Treatment of head and neck epithelial malignant neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101973-PIP01-25
  • Domvanalimab
  • Treatment of head and neck epithelial malignant neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101171-PIP01-23-M02 (update)
  • fosigotifator sodium tromethamine
  • Treatment of vanishing white matter disease
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101937-PIP01-25
  • TISLELIZUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system [CNS], hematopoietic, and lymphoid tissues)
  • Tevimbra
  • Tevimbra
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101911-PIP02-25
  • Lunsekimig
  • Treatment of chronic rhinosinusitis with nasal polyps
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101962-PIP01-25
  • maridebart cafraglutide
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102105-PIP01-25
  • Trontinemab
  • Treatment of Alzheimer's disease
  • Trontinemab
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101911-PIP01-25
  • Lunsekimig
  • Treatment of asthma
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100606-PIP01-22-M02 (update)
  • SPARSENTAN
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Filspari
  • Filspari
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101615-PIP01-24
  • ibuzatrelvir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No