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Displaying 421 - 440 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
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-100272-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. Yes 02/02/2023
MHRA-100271-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. Yes 02/02/2023
MHRA-100369-PIP01-21-M01 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold 123 mg capsules
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100225-PIP01-21-M01 (update)
  • recombinant parathyroid hormone
  • Treatment of hypoparathyroidism
  • Natpar
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100467-PIP01-22-M01 (update)
  • SEMAGLUTIDE
  • Treatment of obesity
  • Ozempic
  • Ozempic 0.25 mg, 0.5 mg, 1 mg
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100405-PIP01-21-M01 (update)
  • LIRAGLUTIDE
  • Treatment of obesity
  • Saxenda
  • Saxenda
  • Saxenda
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100128-PIP01-21-M02 (update)
  • tiomolibdic acid
  • Wilson disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100170-PIP01-21-M02 (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 25/05/2023
MHRA-100323-PIP01-21-M02 (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 30/06/2023
MHRA-100447-PIP01-22-M02 (update)
  • Tirzepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Mounjaro
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100868-PIP01-23-M01 (update)
  • AFAMELANOTIDE
  • Treatment of erythropoietic protoporphyria (EPP)
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100521-PIP01-22-M02 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • 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 19/12/2023
MHRA-100270-PIP01-21-M01 (update)
  • crinecerfont
  • Treatment of congenital adrenal hyperplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100288-PIP01-21-M02 (update)
  • DENOSUMAB
  • Treatment of osteoporosis
  • Prolia
  • Prolia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023