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Displaying 941 - 960 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
PIP Number MHRA-100315-PIP01-21 Active Substance
  • Brensocatib
Conditions / Indications
  • Treatment of non‐cystic fibrosis bronchiectasis
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100316-PIP01-21 Active Substance
  • latozinemab
Conditions / Indications
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
Invented Name Therapeutic area
  • Neurology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100364-PIP01-21 Active Substance
  • Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01
Conditions / Indications
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
Invented Name
  • Not available at present
Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100304-PIP01-21 Active Substance
  • rozibafusp alfa
Conditions / Indications
  • Treatment of systemic lupus erythematosus (SLE)
Invented Name
  • Not available at present
Therapeutic area
  • Immunology -Rheumatology-Transplantation
  • Other: Inflammation-Rheumatology SLE
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100305-PIP01-21 Active Substance
  • Single chain urokinase plasminogen activator (scuPA)
Conditions / Indications
  • Treatment of pleural effusion
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100267-PIP01-21 Active Substance
  • Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene
Conditions / Indications
  • Treatment of beta-thalassemia intermedia and major
Invented Name Therapeutic area
  • Haematology-Hemostaseology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100266-PIP01-21 Active Substance
  • Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene
Conditions / Indications
  • Treatment of sickle cell disease
Invented Name Therapeutic area
  • Haematology-Hemostaseology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100270-PIP01-21 Active Substance
  • crinecerfont
Conditions / Indications
  • Treatment of congenital adrenal hyperplasia
Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100244-PIP01-21 Active Substance
  • surufatinib
Conditions / Indications
  • Treatment of malignant neoplasms
  • Malignant neoplasms of haematopoietic and lymphoid tissue
Invented Name
  • Sevsury
  • Sulanda
Therapeutic area
  • Oncology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100224-PIP01-21 Active Substance
  • Etrasimod L-arginine
Conditions / Indications
  • Treatment of ulcerative colitis
Invented Name
  • Not available at present
Therapeutic area
  • Gastroenterology-Hepatology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100396-PIP01-21 Active Substance
  • sugemalimab
Conditions / Indications
  • Treatment of non-small cell lung cancer (NSCLC)
Invented Name Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100293-PIP01-21 Active Substance
  • lenzilumab
Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
Invented Name
  • Not available at present
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100265-PIP01-21 Active Substance
  • BARICITINIB
Conditions / Indications
  • Treatment of alopecia areata
Invented Name
  • Olumiant
  • Olumiant
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100199-PIP01-21 Active Substance
  • efgartigimod alfa
Conditions / Indications
  • Treatment of Pemphigus
Invented Name Therapeutic area
  • Dermatology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100165-PIP01-21 Active Substance
  • PF-06865571
Conditions / Indications
  • Treatment of non-alcoholic steatohepatitis
Invented Name
  • PF-06865571
Therapeutic area
  • Gastroenterology-Hepatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100109-PIP01-21 Active Substance
  • Islatravir
Conditions / Indications
  • Prevention of human immunodeficiency virus (HIV-1) infection
Invented Name Therapeutic area
  • Infectious diseases
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100100-PIP01-21 Active Substance
  • Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein
Conditions / Indications
  • Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)
Invented Name Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100062-PIP01-21 Active Substance
  • (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate
  • TEZACAFTOR
  • DEUTIVACAFTOR
Conditions / Indications
  • Treatment of Cystic Fibrosis
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100091-PIP01-21 Active Substance
  • Rozanolixizumab
Conditions / Indications
  • Treatment of Immune thrombocytopenia
Invented Name
  • Not available at present
Therapeutic area
  • Haematology-Hemostaseology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100027-PIP01-21 Active Substance
  • benzylamine derivative of benzofuran
Conditions / Indications
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
Invented Name Therapeutic area
  • Haematology-Hemostaseology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending