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Displaying 1 - 20 of 115
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101824-PIP01-25
  • AAV8-RK-AIPL1
  • Treatment of Leber congenital amaurosis
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100297-PIP01-21-M05 (update)
  • Rocatinlimab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102032-PIP01-25-M01 (update)
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
  • Trumenba
  • Trumenba
  • Trumenba
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100471-PIP01-22-M03 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101826-PIP01-25
  • Orforglipron
  • Treatment of obesity
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101319-PIP01-23-M02 (update)
  • denecimig
  • Treatment of haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101174-PIP01-23
  • LENACAPAVIR SODIUM
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Sunlenca
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101357-PIP01-24-M01 (update)
  • inebilizumab
  • Treatment of immunoglobulin G4-related disease (IgG4-RD)
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Xinyue
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102006-PIP01-25
  • beremagene geperpavec
  • Treatment of dystrophic epidermolysis bullosa
  • Vyjuvek
  • Vyjuvek
  • Vyjuvek
  • Vyjuvek
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101112-PIP01-23-M02 (update)
  • Icotrokinra
  • Treatment of psoriasis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100567-PIP01-22-M02 (update)
  • DINUTUXIMAB BETA
  • Treatment of neuroblastoma.
  • Qarziba
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101454-PIP01-24-M01 (update)
  • Donidalorsen
  • Treatment of hereditary angioedema
  • Pneumology - Allergology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100118-PIP01-21-M04 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101923-PIP01-25
  • Pimicotinib hydrochloride hydrate
  • Treatment of tenosynovial giant cell tumours
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102064-PIP01-25-M01 (update)
  • MERCAPTAMINE HYDROCHLORIDE
  • Treatment of cystinosis.
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101905-PIP01-25
  • FUROSEMIDE
  • Treatment of fluid retention
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100443-PIP01-22-M05 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101879-PIP01-25-M01 (update)
  • BECLOMETASONE DIPROPIONATE
  • FORMOTEROL FUMARATE DIHYDRATE
  • GLYCOPYRRONIUM BROMIDE
  • Treatment of asthma
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101995-PIP01-25-M01 (update)
  • ISOFLURANE
  • Sedation of mechanically ventilated patients
  • Sedaconda and associated names
  • Other: Sedation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted