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Displaying 21 - 40 of 1071
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102347-PIP01-26
  • Denecimig
  • Treatment of acquired haemophilia A
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102399-PIP01-26
  • TACROLIMUS MONOHYDRATE
  • Treatment of ulcerative colitis
  • Tacrolimus 4 mg/vial Powder and solvent for rectal suspension
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102322-PIP01-26
  • ifezuntirgene inilparvovec
  • Treatment of Huntington’s disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100750-PIP01-22-M02 (update)
  • setrusumab
  • Treatment of osteogenesis imperfecta
  • Ozyvyo
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102368-PIP01-26
  • COLCHICINE
  • Prevention of cardiovascular events
  • Cloctin XL 0.5mg prolonged release tablets
  • MyInfla
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102401-PIP01-26-M01 (update)
  • ANDEXANET ALFA
  • Treatment of factor Xa inhibitor associated haemorrhage
  • Prevention of factor Xa inhibitor associated haemorrhage
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Ondexxya
  • Andexxa
  • Andexxa
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Andexxa
  • Ondexxya
  • Ondexxya
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102467-PIP01-26-M01 (update)
  • HUMAN FIBRINOGEN
  • Treatment of congenital fibrinogen deficiency
  • Fesilty 1 g Powder and solvent for solution for injection/infusion
  • Fesilty
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102274-PIP01-25
  • Itepekimab
  • Treatment of nasal polyposis
  • Oto-Rhino-Laryngology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102372-PIP01-26
  • Giredestrant
  • Treatment of breast malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102239-PIP01-25
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • baxdrostat
  • Prevention of heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102282-PIP01-25
  • neflamapimod
  • Treatment of dementia with Lewy bodies
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100466-PIP01-22-M02 (update)
  • zilovertamab vedotin
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102040-PIP01-25
  • Brogidirsen
  • Treatment of Duchenne muscular dystrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100445-PIP01-22-M02 (update)
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).
  • Unltomiris
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100078-PIP01-21-M05 (update)
  • AVIBACTAM SODIUM
  • AZTREONAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Emblaveo
  • Emblaveo
  • Emblaveo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100578-PIP01-22-M02 (update)
  • SEMAGLUTIDE
  • Cagrilintide
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102266-PIP01-25
  • Cagrilintide
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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-100558-PIP01-22-M02 (update)
  • milvexian
  • Prevention of thromboembolism in patients with cardiovascular disease
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes