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 381 - 400 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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-100564-PIP01-22-M01 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100501-PIP01-22-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100028-PIP01-21-M01 (update)
  • TIXAGEVIMAB
  • CILGAVIMAB
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment of COVID-19
  • Evusheld
  • Evusheld
  • Evusheld
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100511-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of Crohn's disease
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100535-PIP01-22-M01 (update)
  • UMECLIDINIUM BROMIDE
  • FLUTICASONE FUROATE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Trelegy Ellipta
  • Trelegy Ellipta/ Elebrato/Temybric
  • Trelegy Ellipta
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100479-PIP01-22-M01 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100148-PIP01-21-M02 (update)
  • LENVATINIB MESILATE
  • Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100507-PIP01-22-M01 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100492-PIP01-22-M01 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • Not available at present
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100476-PIP01-22
  • Anti-(alpha-synuclein) human monoclonal antibody
  • Treatment of Multiple System Atrophy
  • Treatment of Parkinson's Disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100481-PIP01-22
  • TUCATINIB
  • Treatment of solid tumours
  • Tukysa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 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
MHRA-100365-PIP01-21
  • Batiraxcept
  • Treatment of Ovarian cancer
  • Treatment of Fallopian tube cancer
  • Treatment of Primary peritoneal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100395-PIP01-21
  • TALAZOPARIB TOSYLATE
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Psychiatry
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100366-PIP01-21
  • Cevostamab
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100383-PIP01-21
  • TRASTUZUMAB DERUXTECAN
  • Treatment of lung cancer
  • Enhertu
  • Enhertu
  • Enhertu
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100465-PIP01-22-M01 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100455-PIP01-22-M01 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022