Displaying 561 - 580 of 773
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100641-PIP01-22-M01 (update)
  • DURVALUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • IMFINZI
  • IMFINZI
  • IMFINZI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100641-PIP01-22-M02 (update)
  • DURVALUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • IMFINZI
  • IMFINZI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 14/08/2023
MHRA-100642-PIP01-22-M01 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
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-100816-PIP01-22-M01 (update)
  • crovalimab
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Treatment of atypical haemolytic uremic syndrome
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100335-PIP01-21-M01 (update)
  • Erdafitinib
  • Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasm)
  • BALVARSA
  • BALVERSA
  • ERFANDEL
  • tablet
  • BALVERSA
  • BALVERSA
  • BALVERSA
  • BALVERSA
  • BALVERSA
  • BALVERSA
  • BALVERSA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100711-PIP01-22-M01 (update)
  • TISAGENLECLEUCEL
  • Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma
  • Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
  • Kymriah
  • Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100815-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Kiendra
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Mayzent
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100817-PIP01-22-M01 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100884-PIP01-23-M01 (update)
  • SACUBITRIL
  • VALSARTAN
  • Treatment of Heart failure
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 25/05/2023
MHRA-100312-PIP01-21-M01 (update)
  • Ritlecitinib
  • Treatment of alopecia areata
  • Litfulo
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100722-PIP01-22
  • Ritlecitinib
  • Treatment of vitiligo
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100567-PIP01-22-M01 (update)
  • Dinutuximab beta
  • Treatment of neuroblastoma
  • Qarziba
  • Qarziba
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100493-PIP01-22
  • BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1
  • Diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100565-PIP01-22
  • MDM2-p53 antagonist
  • Treatment of liposarcoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100555-PIP01-22
  • vepsitamab
  • Treatment of gastric cancer and gastro-oesophageal junction cancer
  • Treatment of colorectal carcinoma
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100599-PIP01-22
  • Flortaucipir F18
  • Diagnosis of Alzheimer's disease
  • Tauvid
  • Tauvid
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100583-PIP01-22
  • SACITUZUMAB GOVITECAN
  • Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100602-PIP01-22
  • monalizumab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100603-PIP01-22
  • Oleclumab
  • Treatment of lung cancer
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023