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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100775-PIP01-22-M02 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • Livmarli (maralixibat chloride)
  • LIVMARLI
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 01/08/2023
MHRA-100775-PIP01-22-M01 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • maralixibat chloride
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 01/08/2023
MHRA-100148-PIP01-21-M03 (update)
  • LENVATINIB MESILATE
  • Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma
  • Lenvima
  • Lenvima
  • Kisplyx
  • Kisplyx
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100846-PIP01-23-M01 (update)
  • ENALAPRIL MALEATE
  • Treatment of heart failure
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023
MHRA-100164-PIP01-21-M02 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100717-PIP01-22-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100130-PIP01-21-M02 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100351-PIP01-21-M01 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100959-PIP01-23-M01 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100475-PIP01-22-M01 (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
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100720-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infections
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100714-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urogenital gonorrhoea (GC)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100709-PIP01-22-M01 (update)
  • rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100447-PIP01-22-M02 (update)
  • Tirzepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Mounjaro
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100349-PIP01-21-M02 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezzayo 200 mg powder for concentrate for solution for infusion
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100323-PIP01-21-M02 (update)
  • SAXAGLIPTIN
  • Treatment of Type 2 Diabetes Mellitus
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Onglyza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100799-PIP01-22-M01 (update)
  • BEDAQUILINE FUMARATE
  • Treatment of multi-drug resistant tuberculosis
  • Sirturo
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100709-PIP01-22-M02 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100553-PIP01-22-M01 (update)
  • REMIMAZOLAM BESYLATE
  • Sedation
  • General Anaesthesia
  • Byfavo 20mg
  • Anerem
  • Byfavo
  • Byfavo
  • Byfavo
  • Anaesthesiology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100701-PIP01-22-M01 (update)
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287- 953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Prevention of meningococcal meningitis
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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