Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 261 - 280 of 478
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100253-PIP01-21-M01 (update)
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100211-PIP01-21-M01 (update)
  • VOLANESORSEN SODIUM
  • Treatment of familial chylomicronemia syndrome
  • WAYLIVRA
  • WAYLIVRA
  • Gastroenterology-Hepatology
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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-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
MHRA-100296-PIP01-21-M01 (update)
  • palovarotene
  • Treatment of fibrodysplasia ossificans progressiva
  • SOHONOS
  • Other: Musculo-skeletal
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-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-100302-PIP01-21-M01 (update)
  • CRIZANLIZUMAB
  • Treatment of sickle cell disease
  • Adakveo® 10 mg/ml concentrate for solution for infusion
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100333-PIP01-21-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100566-PIP01-22-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-101073-PIP01-23-M01 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100340-PIP01-21-M01 (update)
  • LANADELUMAB
  • Prevention of hereditary angioedema attacks
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • Other: Genetic disease
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 07/12/2022
MHRA-100340-PIP01-21-M02 (update)
  • LANADELUMAB
  • Prevention of hereditary angioedema attacks
  • TAKHZYRO
  • TAKZHYRO
  • TAKZHRYO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKZHYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • Other: Genetic disease
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100361-PIP01-21-M01 (update)
  • GOLIMUMAB
  • Treatment of ulcerative colitis
  • Simponi 50 mg solution for injection in pre-filled pen
  • Simponi 50 mg solution for injection in pre-filled syringe
  • Simponi 100 mg solution for injection in pre-filled pen
  • Simponi 45 mg/0.45 mL solution for injection in pre-filled pen
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100361-PIP01-21-M02 (update)
  • GOLIMUMAB
  • Treatment of ulcerative colitis
  • Simponi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100408-PIP01-21-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100557-PIP01-22-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • HEPLISAV-B
  • HEPLISAV-B
  • HEPLISAV B
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100441-PIP01-22-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne Muscular Dystrophy (DMD)
  • Elevidys
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100949-PIP01-23-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne muscular dystrophy
  • Not available
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023