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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101342-PIP01-24-M02 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of Major Depressive Disorder
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101177-PIP01-23-M01 (update)
  • navenibart
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101103-PIP01-23-M01 (update)
  • FINERENONE
  • Treatment of heart failure
  • Kerendia
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100913-PIP01-23-M01 (update)
  • mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA- 1283)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100471-PIP01-22-M02 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • Nutrition
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100443-PIP01-22-M04 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100424-PIP01-22-M01 (update)
  • zilebesiran sodium
  • Treatment of hypertension
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100392-PIP01-21-M06 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • FAMTOZINAMERAN
  • RILTOZINAMERAN
  • RAXTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection, COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100218-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100214-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uraemic syndrome (aHUS)
  • Ultomiris
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100213-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Ultomiris
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100212-PIP01-21-M03 (update)
  • FINERENONE
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100183-PIP01-21-M04 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100237-PIP01-21-M02 (update)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Prevention of influenza infection
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (QIV-HD)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101407-PIP01-24-M01 (update)
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Infectious diseases
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100714-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated gonorrhoea
  • Blujepa
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100087-PIP01-21-M03 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • VIMPAT
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100455-PIP01-22-M02 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100949-PIP01-23-M02 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne muscular dystrophy
  • Elevidys
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100517-PIP01-22-M04 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla 10 mg, 20 mg, 30 mg film coated tablets, Otezla 30 mg film coated tablets
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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