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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
MHRA-101186-PIP01-23
  • FARICIMAB
  • Treatment of choroidal neovascularisation secondary to pathologic myopia
  • Vabysmo
  • Vabysmo
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101324-PIP01-23-M01 (update)
  • REGADENOSON
  • Diagnosis of myocardial perfusion disturbances
  • Rapiscan
  • Rapiscan
  • Rapiscan
  • Cardiovascular Diseases
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101288-PIP01-23
  • Interleukin-2
  • Interleukin-1 beta, human
  • Granulocyte colony-stimulating factor
  • Tumor necrosis factor-alpha
  • Interferon gamma
  • Treatment of squamous cell carcinoma of the head and neck (SCCHN)
  • Multikine
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101007-PIP01-23
  • tiragolumab
  • ATEZOLIZUMAB
  • Treatment of lung carcinoma (non-small cell carcinoma)
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100968-PIP01-23
  • dirloctocogene samoparvovec
  • Treatment of congenital haemophilia A
  • Not available at present
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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