Displaying 681 - 700 of 773
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-100048-PIP01-21
  • Afamitresgene autoleucel
  • Treatment of soft tissue sarcoma
  • Not available at present.
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100043-PIP01-21
  • zilucoplan
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilqivik
  • Neurology
  • Other: Neurodegenerative disorder, auto-immune disease/dysfunction
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) 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-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-100044-PIP01-21
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100080-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of Immune Thrombocytopenic Purpura
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100185-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of cold agglutinin disease
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100556-PIP01-22
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
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-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. No 30/04/2024
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-100142-PIP01-21
  • Synthetic Hypericin
  • Treatment of cutaneous T-cell lymphoma
  • HyBryte
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). 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-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-100131-PIP01-21
  • ATEZOLIZUMAB
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100109-PIP01-21
  • Islatravir
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022