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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
PIP Number MHRA-101333-PIP01-24 Active Substance
  • 2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)-1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate
 Conditions / Indications
  • Treatment of Parkinson's disease
 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 28/10/2024
PIP Number MHRA-101292-PIP01-23 Active Substance
  • Complement Factor B Antisense Oligonucleotide (RO7434656)
 Conditions / Indications
  • Treatment of primary immunoglobulin A nephropathy
 Invented Name
  • Not available at present
 Therapeutic area
  • Uro-Nephrology
 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 28/10/2024
PIP Number MHRA-101307-PIP01-23 Active Substance
  • inaxaplin
 Conditions / Indications
  • Treatment of apolipoprotein L1 (APOL1) -mediated kidney disease
 Invented Name Therapeutic area
  • Uro-Nephrology
 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 28/10/2024
PIP Number MHRA-101047-PIP01-23 Active Substance
  • vesleteplirsen
Conditions / Indications
  • Treatment of Duchenne muscular dystrophy
 Invented Name Therapeutic area
  • Neurology
 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 28/10/2024
PIP Number MHRA-100242-PIP01-21 Active Substance
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
 Conditions / Indications
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus.
Invented Name 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 24/10/2024
PIP Number MHRA-100139-PIP01-21 Active Substance
  • Teplizumab
 Conditions / Indications
  • Prevention or delay of (clinical) type 1 diabetes mellitus
 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 Yes Compliance outcome Date Published 09/10/2024
PIP Number MHRA-101170-PIP01-23 Active Substance
  • IRINOTECAN HYDROCHLORIDE TRIHYDRATE
 Conditions / Indications
  • Treatment of pancreatic cancer
 Invented Name
  • ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
  • ONIVYDE pegylated liposomal
 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 03/10/2024
PIP Number MHRA-101132-PIP01-23 Active Substance
  • Vepdegestrant
 Conditions / Indications
  • Treatment breast malignant neoplasms
 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 03/10/2024
PIP Number MHRA-101120-PIP01-23 Active Substance
  • RVT-802 (allogeneic cultured postnatal thymus tissue-derived product)
 Conditions / Indications
  • Treatment of congenital athymia
 Invented Name
  • RETHYMIC
  • RETHYMIC
 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 03/10/2024
PIP Number MHRA-100351-PIP01-21-M03 (update) Active Substance
  • RILPIVIRINE
  • DOLUTEGRAVIR
 Conditions / Indications
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
Invented Name
  • JULUCA
  • JULUCA
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-100197-PIP01-21-M03 (update) Active Substance
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
 Conditions / Indications
  • Prevention of Ebola disease
 Invented Name
  • ERVEBO
  • ERVEBO
 Therapeutic area
  • Vaccines
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101439-PIP01-24-M01 (update) Active Substance
  • (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one
 Conditions / Indications
  • Treatment of Multiple Sclerosis
 Invented Name Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101513-PIP01-24-M01 (update) Active Substance
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
 Conditions / Indications
  • Treatment of Type 2 Diabetes Mellitus
 Invented Name
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101494-PIP01-24-M01 (update) Active Substance
  • LUSPATERCEPT
 Conditions / Indications
  • Treatment of myelodysplastic syndromes. Treatment of beta-thalassaemia.
 Invented Name
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
 Therapeutic area
  • Haematology-Hemostaseology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101078-PIP01-23-M02 (update) Active Substance
  • OLAPARIB
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
 Invented Name
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101112-PIP01-23-M01 (update) Active Substance
  • Interleukin-23 receptor antagonist peptide (JNJ-77242113)
Conditions / Indications
  • Treatment of psoriasis.
 Invented Name Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101468-PIP01-24 Active Substance
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • baxdrostat
 Conditions / Indications
  • Treatment of Chronic Kidney Disease
 Invented Name Therapeutic area
  • Uro-Nephrology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-100239-PIP01-21-M01 (update) Active Substance
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
 Conditions / Indications
  • Prevention of disease caused by Streptococcus pneumoniae
 Invented Name
  • Not available at present
Therapeutic area
  • Vaccines
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 03/10/2024
PIP Number MHRA-101422-PIP01-24 Active Substance
  • Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)
 Conditions / Indications
  • Prevention of influenza and coronavirus disease 2019 (COVID-19)
 Invented Name 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 03/10/2024
PIP Number MHRA-101378-PIP01-24 Active Substance
  • UPADACITINIB
 Conditions / Indications
  • Treatment of hidradenitis suppurativa
 Invented Name
  • Rinvoq
 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 03/10/2024
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