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Displaying 101 - 120 of 426
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100108-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of epilepsy with partial onset seizures.
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • BRIVLERA
  • BRIVLERA
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M03 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100137-PIP01-21-M01 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100137-PIP01-21-M02 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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-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-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-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-100213-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100214-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of atypical Haemolytic Uremic Syndrome
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100213-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100214-PIP01-21-M03 (update)
  • RAVULIZUMAB
  • atypical haemolytic uremic syndrome (aHUS)
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100216-PIP01-21-M01 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralaza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100216-PIP01-21-M02 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100217-PIP01-21-M01 (update)
  • ERIBULIN
  • Treatment of soft tissue sarcoma
  • Halaven
  • Halaven
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100229-PIP01-21-M01 (update)
  • NINTEDANIB
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Ofev
  • Vargatef
  • Ofev
  • Vargatef
  • Pneumology - Allergology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100247-PIP01-21-M01 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100248-PIP01-21-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022