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Displaying 521 - 540 of 600
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100040-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100128-PIP01-21-M01 (update)
  • bis-choline tetrathiomolybdate
  • Treatment of Wilson disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100154-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100157-PIP01-21-M01 (update)
  • EXENATIDE
  • Type 2 diabetes mellitus
  • Byetta
  • Bydureon
  • Bydureon BCise
  • Byetta
  • Byetta
  • Bydureon
  • Bydureon
  • Byetta
  • Bydureon
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 18/03/2022
MHRA-100167-PIP01-21-M01 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100205-PIP01-21-M01 (update)
  • EMPAGLIFLOZIN
  • Treatment of Type 2 Diabetes Mellitus
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100207-PIP01-21-M01 (update)
  • LINAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Trajenta
  • Trajenta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100206-PIP01-21
  • EMPAGLIFLOZIN
  • Treatment of ischaemic heart disease
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100058-PIP01-21-M01 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100129-PIP01-21-M01 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/07/2022
MHRA-100170-PIP01-21-M01 (update)
  • CANAGLIFLOZIN HEMIHYDRATE
  • Treatment of Type 2 Diabetes Mellitus
  • Invokana
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100222-PIP01-21-M01 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100259-PIP01-21-M01 (update)
  • DULAGLUTIDE
  • Treatment of Type 2 Diabetes Mellitus
  • Trulicity
  • Trulicity
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100521-PIP01-22-M01 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 29/07/2022
MHRA-100182-PIP01-21-M01 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100328-PIP01-21-M01 (update)
  • METRELEPTIN
  • Treatment of lipodystrophy
  • Myalepta Powder for Solution for Injection
  • Myalepta
  • Myalepta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100288-PIP01-21-M01 (update)
  • DENOSUMAB
  • Treatment of osteoporosis
  • Prolia
  • Prolia
  • Prolia
  • Prolia
  • XGEVA
  • XGEVA
  • XGEVA
  • XGEVA
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100323-PIP01-21-M01 (update)
  • SAXAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100447-PIP01-22-M01 (update)
  • tirzepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100404-PIP01-21
  • insulin icodec
  • SEMAGLUTIDE
  • Treatment of type 2 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022