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Displaying 161 - 180 of 295
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Sort descending Compliance outcome Date Published
MHRA-100588-PIP01-22
  • UB-612
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100439-PIP01-22
  • Asundexian
  • Prevention of arterial thromboembolism
  • Not available at present.
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100628-PIP01-22
  • Sibeprenlimab
  • Treatment of primary immunoglobulin A nephropathy
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100559-PIP01-22
  • mitapivat
  • Treatment of thalassaemia
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100606-PIP01-22
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100635-PIP01-22
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • INAQOVI
  • Haematology-Hemostaseology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100186-PIP01-21
  • depemokimab
  • Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)
  • Depemokimab
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100224-PIP02-22
  • Etrasimod L-arginine
  • Treatment of Crohn’s disease
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100316-PIP02-22
  • latozinemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100545-PIP01-22
  • Lutetium (177Lu) edotreotide
  • Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100637-PIP01-22
  • Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus
  • Treatment of chronic hepatitis D 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 25/05/2023
MHRA-100632-PIP01-22-M01 (update)
  • FLUCICLOVINE (18F)
  • Diagnosis of amino acid metabolism in solid malignant tumours
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100493-PIP01-22
  • BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1
  • Diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100565-PIP01-22
  • MDM2-p53 antagonist
  • Treatment of liposarcoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100555-PIP01-22
  • vepsitamab
  • Treatment of gastric cancer and gastro-oesophageal junction cancer
  • Treatment of colorectal carcinoma
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100599-PIP01-22
  • Flortaucipir F18
  • Diagnosis of Alzheimer's disease
  • Tauvid
  • Tauvid
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100583-PIP01-22
  • SACITUZUMAB GOVITECAN
  • Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100602-PIP01-22
  • monalizumab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100603-PIP01-22
  • Oleclumab
  • Treatment of lung cancer
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100577-PIP01-22
  • ziltivekimab
  • Treatment of heart failure
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023