Displaying 1 - 20 of 933
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100139-PIP01-21
  • Teplizumab
  • Prevention or delay of (clinical) type 1 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 09/10/2024
MHRA-101170-PIP01-23
  • IRINOTECAN HYDROCHLORIDE TRIHYDRATE
  • Treatment of pancreatic cancer
  • ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
  • ONIVYDE pegylated liposomal
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-101132-PIP01-23
  • Vepdegestrant
  • Treatment breast malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-101120-PIP01-23
  • RVT-802 (allogeneic cultured postnatal thymus tissue-derived product)
  • Treatment of congenital athymia
  • RETHYMIC
  • RETHYMIC
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-100351-PIP01-21-M03 (update)
  • RILPIVIRINE
  • DOLUTEGRAVIR
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-100197-PIP01-21-M03 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101439-PIP01-24-M01 (update)
  • (R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one
  • Treatment of Multiple Sclerosis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101513-PIP01-24-M01 (update)
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
  • Treatment of Type 2 Diabetes Mellitus
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101494-PIP01-24-M01 (update)
  • LUSPATERCEPT
  • Treatment of myelodysplastic syndromes. Treatment of beta-thalassaemia.
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101078-PIP01-23-M02 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101112-PIP01-23-M01 (update)
  • Interleukin-23 receptor antagonist peptide (JNJ-77242113)
  • Treatment of psoriasis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101468-PIP01-24
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • baxdrostat
  • Treatment of Chronic Kidney Disease
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-100239-PIP01-21-M01 (update)
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
  • Prevention of disease caused by Streptococcus pneumoniae
  • Not available at present
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101422-PIP01-24
  • 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)
  • Prevention of influenza and coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-101378-PIP01-24
  • UPADACITINIB
  • Treatment of hidradenitis suppurativa
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-100428-PIP01-22-M02 (update)
  • LENACAPAVIR SODIUM
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Sunlenca
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101431-PIP01-24
  • SODIUM PHENYLBUTYRATE
  • Ursodoxicoltaurine
  • Treatment of progressive supranuclear palsy
  • Relyvrio
  • Albrioza
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-101388-PIP01-24-M01 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia.
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-101326-PIP01-24
  • Human IgG4 monoclonal antibody against BCMA and CD3
  • Treatment of multiple myeloma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-101338-PIP01-24
  • elinzanetant
  • Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024