Displaying 521 - 540 of 970
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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-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-100283-PIP01-21-M02 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Gastroenterology-Hepatology
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-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-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-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-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-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-100114-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
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-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-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-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-100674-PIP01-22-M01 (update)
  • DARATUMUMAB
  • Treatment of lymphoid malignancies (except mature B-cell neoplasms)
  • Darzalex
  • Darzalex
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100646-PIP01-22-M01 (update)
  • TOLVAPTAN
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100618-PIP01-22-M01 (update)
  • AVIBACTAM
  • CEFTAZIDIME
  • Treatment of intra-abdominal infections
  • Treatment of urinary tract infections
  • Treatment of pneumonia
  • Treatment of infections due aerobic Gram-negative organisms.
  • Zavicefta
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100550-PIP01-22-M01 (update)
  • BELIMUMAB
  • Treatment of systemic lupus erythematosus
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100547-PIP01-22-M01 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023