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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-102032-PIP01-25-M01 (update)
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
  • Trumenba
  • Trumenba
  • Trumenba
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101813-PIP01-25
  • Islatravir
  • LENACAPAVIR SODIUM
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101712-PIP01-24
  • Tebipenem pivoxil (as the hydrobromide salt)
  • Treatment of urinary tract infection
  • Not available at present
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101913-PIP01-25
  • antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to N-acetylgalactosamine (AZD2693), sodium salt
  • Treatment of metabolic dysfunction-associated steatohepatitis (MASH)
  • Not available at present
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101893-PIP01-25
  • eneboparatide
  • Treatment of hypoparathyroidism
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101791-PIP01-25
  • Bexicaserin
  • Treatment of seizures and seizure disorders
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100444-PIP01-22-M02 (update)
  • ETELCALCETIDE
  • Treatment of hyperparathyroidism
  • Parsabiv
  • Parsabiv
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102178-PIP01-25
  • LECANEMAB
  • Treatment of Alzheimer's disease
  • LEQEMBI
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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-100471-PIP01-22-M03 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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
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