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Displaying 21 - 40 of 104
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100959-PIP01-23-M01 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100741-PIP01-22
  • CRISANTASPASE
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
  • Enrylaze
  • Rylaze
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 19/12/2023
MHRA-100787-PIP01-22
  • Repotrectinib
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
  • Not available at present
  • Oncology
  • Other: Not Applicable
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 19/12/2023
MHRA-100642-PIP01-22-M02 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Tremelimumab AstraZeneca
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 19/12/2023
MHRA-100117-PIP01-21-M03 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/01/2024
MHRA-101131-PIP01-23-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCTYO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
MHRA-100240-PIP01-21-M04 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukemia
  • Bosulif
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/04/2024
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-100811-PIP01-22-M01 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100630-PIP01-22-M01 (update)
  • PATIROMER SORBITEX CALCIUM
  • Treatment of hyperkalaemia
  • Veltassa
  • Other: Nephrology/Metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100844-PIP01-23-M01 (update)
  • IVACAFTOR
  • Treatment of cystic fibrosis.
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 24/08/2023
MHRA-101293-PIP01-23-M01 (update)
  • METHOXYFLURANE
  • Treatment of acute pain
  • Penthrox
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/04/2024
MHRA-100312-PIP01-21
  • Ritlectinib
  • Treatment of alopecia areata
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 29/07/2022
MHRA-100718-PIP01-22-M01 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100897-PIP01-23-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-101058-PIP01-23
  • SIROLIMUS
  • Treatment of Tuberous Sclerosis
  • Pascomer
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 30/01/2024