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Displaying 41 - 60 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-102337-PIP01-26
  • Zanzalintinib
  • Treatment of neuroendocrine tumours (except neuroblastoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102155-PIP01-25
  • Zosurabalpin
  • Treatment of infections due to Acinetobacter baumannii-calcoaceticus complex
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102349-PIP01-26-M01 (update)
  • CANGRELOR
  • Prevention of non-site specific embolism and thrombosis
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Kengrexal
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102314-PIP01-26
  • BMS-986504/MRTX1719
  • Treatment of lung cancer
  • Treatment of Pancreatic cancer
  • Navlimetostat
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102445-PIP01-26-M01 (update)
  • PRETOMANID
  • Treatment of multi-drug-resistant tuberculosis
  • Dovprela
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-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-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