Displaying 501 - 520 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-100468-PIP01-22-M02 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Vyepti
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100405-PIP01-21-M01 (update)
  • LIRAGLUTIDE
  • Treatment of obesity
  • Saxenda
  • Saxenda
  • Saxenda
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100499-PIP01-22-M01 (update)
  • Giroctocogene Fitelparvovec
  • Treatment of haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100451-PIP01-22-M01 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100451-PIP01-22-M02 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100472-PIP01-22
  • Tarlatamab
  • Treatment of small cell lung cancer (SCLC)
  • Treatment of prostate malignant neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100634-PIP01-22
  • Ceralasertib
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100585-PIP01-22
  • Adintrevimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Bredaygio
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100514-PIP01-22
  • Gliadin Protease
  • Treatment of coeliac 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-100508-PIP01-22
  • tezepelumab
  • Treatment of chronic spontaneous urticaria
  • Not available at present
  • TEZSPIRE
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100345-PIP01-21
  • Magrolimab
  • Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia)
  • Treatment of acute myeloid leukaemia
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
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-100605-PIP01-22
  • sparsentan
  • Treatment of immunoglobulin A nephropathy
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 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-100606-PIP01-22-M01 (update)
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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