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Displaying 61 - 80 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-100068-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100068-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100072-PIP01-21-M01 (update)
  • COVID-19 Vaccine (ChAdOx1-S [recombinant])
  • Prevention of coronavirus disease 2019 (COVID-19)
  • COVID-19 Vaccine AstraZeneca
  • COVID-19 Vaccine AstraZeneca
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100078-PIP01-21-M01 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Not available at present
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100078-PIP01-21-M03 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100078-PIP01-21-M02 (update)
  • AVIBACTAM
  • AZTREONAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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-100093-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100086-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of atopic dermatitis
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100093-PIP01-21-M02 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100093-PIP01-21-M03 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100084-PIP01-21-M01 (update)
  • MIDOSTAURIN
  • Treatment of acute myeloid leukaemia
  • Malignant mastocytosis
  • Mast cell leukaemia
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100089-PIP01-21-M01 (update)
  • dupilumab
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100090-PIP01-21-M01 (update)
  • DUPILUMAB
  • Treatment of atopic dermatitis
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100586-PIP01-22-M01 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100089-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/04/2024
MHRA-100118-PIP01-21-M01 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100118-PIP01-21-M02 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100119-PIP01-21-M01 (update)
  • TEZACAFTOR
  • IVACAFTOR
  • Treatment of Cystic Fibrosis
  • Symkevi
  • Symkevi
  • Symkevi
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022