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Displaying 81 - 100 of 840
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102302-PIP01-26
  • mRNA encoding Influenza A, subtype H5N1, strain A/chicken/Ghana/2021, haemagglutinin
  • Prevention of pandemic influenza
  • Vaccines
  • Other: mRNA vaccine
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101669-PIP01-24
  • Zerlasiran
  • Prevention of cardiovascular events
  • zerlasiran
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102311-PIP01-26
  • EYE103 / MK-3000
  • Treatment of diabetic macular oedema
  • Not available at present
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102154-PIP01-25
  • AMIVANTAMAB
  • Head and neck epithelial malignant neoplasms
  • Rybrevant
  • Rybrevant
  • Rybrevant
  • Rybrevant
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101250-PIP01-23-M02 (update)
  • RISANKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis).
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102219-PIP01-25
  • MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
  • Treatment of VEXAS syndrome in adults.
  • Omjjara
  • Omjjara 100mg film-coated tablets (PLGB 19494/0318)
  • Omjjara 150mg film-coated tablets (PLGB 19494/0322)
  • Omjjara 200mg film-coated tablets (PLGB 19494/0323)
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • OJJAARA
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Other: hemato-inflammatory condition
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101388-PIP01-24-M06 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101692-PIP01-24-M02 (update)
  • Atogepant
  • atogepant
  • Prevention of migraine headaches
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102261-PIP01-25
  • Human IgG1 kappa monoclonal antibody against TREM2
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102123-PIP01-25
  • Gocatamig
  • Treatment of small cell lung cancer (SCLC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
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