Search Filters:

Displaying 941 - 960 of 1097
Download
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Download XLSX