Displaying 61 - 80 of 1049
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101523-PIP01-24
  • Raludotatug deruxtecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of primary peritoneal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101497-PIP01-24
  • laruparetigene zovaparvovec
  • Recombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR)
  • Treatment of X-linked retinitis pigmentosa (XLRP)
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024
MHRA-100492-PIP01-22-M02 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • MOLBREEVI
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/11/2024
MHRA-101521-PIP01-24
  • Derivative of 6-(piperidine-1-carbonyl)pyridine-3-ol
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024
MHRA-101506-PIP01-24
  • Zongertinib
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101482-PIP01-24-M01 (update)
  • BELATACEPT
  • Prevention of rejection of transplanted kidney
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/11/2024
MHRA-100247-PIP01-21-M02 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/11/2024
MHRA-101489-PIP01-24
  • Enlicitide (decanoate)
  • Treatment of hypercholesterolemia
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024
MHRA-101442-PIP01-24
  • Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)
  • Treatment of urothelial carcinoma
  • Treatment of cutaneous squamous cell carcinoma
  • Treatment of renal cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101384-PIP01-24
  • Telisotuzumab adizutecan
  • Treatment of colorectal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101500-PIP01-24
  • Zanidatamab
  • Treatment of gastroesophageal adenocarcinoma (GEA).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101499-PIP01-24
  • Zanidatamab
  • Treatment of HER2-positive breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101426-PIP01-24
  • Deutetrabenazine
  • Treatment of tardive dyskinesia
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101319-PIP01-23-M01 (update)
  • denecimig
  • Treatment of haemophilia A
  • Not available at present
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/11/2024
MHRA-101129-PIP01-23
  • Domvanalimab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101128-PIP01-23
  • Domvanalimab
  • Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101441-PIP01-24
  • modified recombinant version of the human myeloid-derived growth factor
  • Treatment of ischaemic coronary artery disorders
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101199-PIP01-23
  • Inhibitor of receptor-interacting protein kinase 1
  • Treatment of ulcerative colitis
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024
MHRA-101174-PIP01-23
  • LENACAPAVIR SODIUM
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Sunlenca
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024
MHRA-100961-PIP01-23
  • depemokimab
  • Treatment of hypereosinophilic syndrome (HES)
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/11/2024