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Displaying 41 - 60 of 426
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100543-PIP01-22-M01 (update)
  • LAMIVUDINE
  • DOLUTEGRAVIR
  • Treatment of Human Immunodeficiency virus type 1 (HIV - 1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100076-PIP01-21-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100571-PIP01-22-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Viread
  • Viread
  • Viread
  • Viread
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100097-PIP01-21-M01 (update)
  • eladocagene exuparvovec
  • Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
  • Upstaza
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100098-PIP01-21-M01 (update)
  • ATALUREN
  • Treatment of dystrophinopathy
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100098-PIP01-21-M02 (update)
  • ATALUREN
  • Treatment of dystrophinopathy
  • Translarna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 19/12/2023
MHRA-100128-PIP01-21-M01 (update)
  • bis-choline tetrathiomolybdate
  • Treatment of Wilson disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100148-PIP01-21-M01 (update)
  • LENVATINIB MESILATE
  • Treatment of all conditions included in the category of malignant neoplasms
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100148-PIP01-21-M02 (update)
  • LENVATINIB MESILATE
  • Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100609-PIP01-22-M01 (update)
  • LENVATINIB MESILATE
  • Treatment of papillary thyroid cancer and follicular thyroid cancer
  • Treatment of osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100148-PIP01-21-M03 (update)
  • LENVATINIB MESILATE
  • Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma
  • Lenvima
  • Lenvima
  • Kisplyx
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100154-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100203-PIP01-21-M01 (update)
  • Avacopan
  • Treatment of 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 17/12/2021
MHRA-100079-PIP01-21-M01 (update)
  • gilteritinib (as fumarate)
  • Treatment of acute myeloid leukaemia
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/03/2022
MHRA-100043-PIP01-21-M01 (update)
  • zilucoplan
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilqivik
  • Neurology
  • Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100294-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of asthma
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100141-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100376-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 22/12/2022
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-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