Displaying 81 - 100 of 1085
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102134-PIP01-25
  • Enicepatide
  • 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-102357-PIP01-26
  • LAROPROVSTAT
  • ROSUVASTATIN CALCIUM
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102355-PIP01-26
  • LAROPROVSTAT
  • ROSUVASTATIN CALCIUM
  • Treatment of elevated cholesterol
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102299-PIP01-26
  • CRB-701
  • Treatment of cervical cancer
  • Treatment of head and neck epithelial malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
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-102245-PIP01-25
  • matrix applied characterised autologous cultured chondrocytes
  • Treatment of cartilage disorders
  • MACI
  • MACI
  • Other: Orthopaedics
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
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-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