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Displaying 1 - 20 of 831
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102201-PIP01-25-M01 (update)
  • Peanut Allergen Extract
  • Treatment of peanut allergy
  • DBV712 250 µg cutaneous patch
  • Other: Food allergy (peanut)
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102339-PIP01-26
  • Zelenectide pevedotin
  • Treatment of urothelial carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102320-PIP01-26
  • Zelenectide pevedotin
  • Treatment of breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101810-PIP01-25
  • Livmoniplimab
  • Treatment of all conditions included in the category of malignant neoplasms except melanoma, central nervous neoplasms, haematopoietic and lymphoid tissues neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102212-PIP01-25
  • sotatercept
  • Treatment of pulmonary hypertension due to left heart disease
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101986-PIP01-25
  • CEMIPLIMAB
  • FIANLIMAB
  • Treatment of melanoma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101786-PIP01-25
  • (R)-N-(3-(2-Chloro-5-fluorophenyl)-6-(5-cyano-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-1-oxoisoindolin-4-yl)-3-fluoro-5-(trifluoromethyl)benzamide
  • Treatment of PIK3CA-related disorders with vascular malformations and/or overgrowth spectrum
  • Other: Vascular disorders; Congenital, hereditary, and genetic disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100143-PIP01-21-M03 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102192-PIP01-25
  • casdatifan
  • Treatment of renal cell carcinoma (RCC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100079-PIP01-21-M05 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Gilteritinib Astellas
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102232-PIP01-25
  • Napazimone
  • Treatment of primary mitochondrial disease
  • Other: Genetic mitochondrial abnormalities NEC
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101894-PIP01-25
  • nomlabofusp
  • Treatment of Friedreich’s ataxia
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101880-PIP02-25
  • Duvakitug
  • 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
MHRA-102318-PIP01-26
  • Taletrectinib adipate
  • Treatment of non-small cell lung cancer
  • Not available at present
  • DOVBLERON
  • IBTROZI
  • IBTROZI
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102197-PIP01-25
  • DIFLUNISAL
  • Treatment of transthyretin amyloidosis
  • Attrogy
  • Attrogy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100212-PIP01-21-M04 (update)
  • FINERENONE
  • Treatment of chronic kidney disease.
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100951-PIP01-23-M04 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100347-PIP01-21-M01 (update)
  • Respiratory syncytial virus vaccine (bivalent, recombinant)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus via maternal immunisation.
  • 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-102198-PIP01-25
  • Humanized IgG1 monoclonal antibody against thymic stromal lymphopoietin
  • Treatment of nasal polyposis
  • Oto-Rhino-Laryngology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100392-PIP01-21-M07 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2); Tozinameran; Famtozinameran; Riltozinameran; Raxtozinameran; Bretovameran Cemivameran; COVID-19 mRNA Vaccine
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial, Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection, COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No