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Displaying 1 - 20 of 843
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102387-PIP01-26
  • NETUPITANT
  • PALONOSETRON HYDROCHLORIDE
  • Prevention of chemotherapy-induced nausea and vomiting
  • AKYNZEO
  • AKYNZEO
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  • AKYNZEO
  • Other: Cancer supportive care
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102248-PIP01-25
  • AMG 732
  • Treatment of thyroid eye disease
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100811-PIP01-22-M05 (update)
  • Vamorolone
  • Treatment of Duchenne Muscular Dystrophy.
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • AGAMREE
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100351-PIP01-21-M04 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102313-PIP01-26
  • Lorecivivint
  • Treatment of osteoarthritis of the knee and hip
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
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