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Displaying 61 - 80 of 838
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100070-PIP01-21-M02 (update)
  • molnupiravir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100253-PIP01-21-M03 (update)
  • Zuranolone
  • Treatment of post-partum depression
  • Zurzuvae
  • Zurzuvae 20mg
  • Zurzuvae 20mg Hard Capsules
  • Zurzuvae 20mg Hard Capsules
  • Zurzuvae 25mg Hard Capsules
  • Zurzuvae 20mg Hard Capsules
  • Zurzuvae 25mg Hard Capsules
  • Zurzuvae 25mg Hard Capsules
  • Zurzuvae 30mg Hard Capsules
  • Zurzuvae
  • Zurzuvae 20mg. 25mg and 30mg Hard Capsules
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101616-PIP01-24
  • Multivalent pneumococcal polysaccharide vaccine
  • Prevention of pneumococcal disease caused by S. pneumoniae
  • N/A
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102227-PIP01-25
  • BEMPEDOIC ACID
  • EZETIMIBE
  • ATORVASTATIN
  • Treatment of mixed dyslipidaemia
  • Bempedoic acid, Ezetimibe, Atorvastatin
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102226-PIP01-25
  • BEMPEDOIC ACID
  • EZETIMIBE
  • ATORVASTATIN
  • Treatment of elevated cholesterol
  • Bempedoic acid, Ezetimibe, Atorvastatin
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101093-PIP03-25
  • satralizumab
  • Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease
  • Enspryng
  • Enspryng
  • Enspryng
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102258-PIP01-25
  • LEVODOPA
  • CARBIDOPA MONOHYDRATE
  • Treatment of Parkinson’s disease
  • Crexont
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101802-PIP01-25-M01 (update)
  • Efzimfotase alfa
  • Treatment of hypophosphatasia
  • Zimphique
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102334-PIP01-26-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of IgA Nephropathy
  • Fabhalta
  • Fabhalta
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102387-PIP01-26
  • NETUPITANT
  • PALONOSETRON HYDROCHLORIDE
  • Prevention of chemotherapy-induced nausea and vomiting
  • AKYNZEO
  • AKYNZEO
  • AKYNZEO
  • AKYNZEO
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  • AKYNZEO
  • AKYNZEO
  • 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