Displaying 221 - 240 of 1088
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100283-PIP01-21-M03 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100274-PIP01-21-M02 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100272-PIP01-21-M01 (update)
  • EMPAGLIFLOZIN
  • Treatment of Type 2 Diabetes Mellitus
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100271-PIP01-21-M01 (update)
  • LINAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Trajenta
  • Trajenta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100262-PIP01-21-M02 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Xydalba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100259-PIP01-21-M01 (update)
  • DULAGLUTIDE
  • Treatment of Type 2 Diabetes Mellitus
  • Trulicity
  • Trulicity
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100247-PIP01-21-M02 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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 Full Compliance Check Granted
MHRA-100235-PIP01-21-M03 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100229-PIP01-21-M01 (update)
  • NINTEDANIB
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Ofev
  • Vargatef
  • Ofev
  • Vargatef
  • Pneumology - Allergology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100221-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of atopic dermatitis
  • Olumiant
  • Olumiant
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101812-PIP01-25
  • BICTEGRAVIR
  • LENACAPAVIR SODIUM
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100218-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100203-PIP01-21-M02 (update)
  • Avacopan
  • Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
  • Tavneos
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100198-PIP01-21-M01 (update)
  • RURIOCTOCOG ALFA PEGOL
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
  • Adynovi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100197-PIP01-21-M03 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100170-PIP01-21-M02 (update)
  • CANAGLIFLOZIN HEMIHYDRATE
  • Treatment of Type 2 Diabetes Mellitus
  • Invokana
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100168-PIP01-21-M01 (update)
  • Naloxegol (as naloxegol oxalate)
  • Treatment of opioid-induced constipation
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100166-PIP01-21-M01 (update)
  • ENTRECTINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100161-PIP01-21-M01 (update)
  • Pneumococcal Polysaccharide Serotype 1 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 3 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 4 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 5 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6B - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9V - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 14 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 18C - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F - Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Not available at present
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted