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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
MHRA-100443-PIP01-22-M03 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis).
  • Baricitinib Lilly
  • Olumiant
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100119-PIP01-21-M02 (update)
  • TEZACAFTOR
  • IVACAFTOR
  • Treatment of Cystic Fibrosis
  • Symkevi
  • Symkevi (tezacaftor/ivacaftor)
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100544-PIP01-22-M03 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100743-PIP01-22-M03 (update)
  • efgartigimod alfa
  • Treatment of generalised myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100066-PIP01-21-M02 (update)
  • efgartigimod alfa
  • Treatment of myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101720-PIP01-24-M01 (update)
  • PEGCETACOPLAN
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • ASPAVELI
  • ASPAVELI
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100909-PIP01-23-M02 (update)
  • ABEMACICLIB
  • Treatment of Ewing's sarcoma
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101006-PIP01-23-M02 (update)
  • IMLIFIDASE
  • Prevention of graft rejection following solid organ transplantation
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100118-PIP01-21-M03 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100475-PIP01-22-M02 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • MenQuadfi
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101044-PIP01-23-M02 (update)
  • INCLISIRAN SODIUM
  • Treatment of elevated cholesterol
  • Leqvio
  • Leqvio
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Other: chemically synthesized small interfering RNA (siRNA)
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100297-PIP01-21-M04 (update)
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of atopic dermatitis
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100910-PIP01-23-M03 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Verzenios
  • Verzenios
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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