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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
MHRA-100250-PIP01-21-M02 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100645-PIP01-22-M01 (update)
  • AMIKACIN SULFATE
  • Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients
  • Treatment of non-tuberculous mycobacterial lung infection
  • Arikayce
  • Arikayce
  • Arikayce liposomal
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100614-PIP01-22-M01 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100535-PIP01-22-M02 (update)
  • FLUTICASONE FUROATE
  • UMECLIDINIUM BROMIDE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Trelegy Ellipta
  • Trelegy Ellipta
  • Trelegy Ellipta/ Elebrato Ellipta
  • Trelegy Ellipta
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100805-PIP01-22-M01 (update)
  • ATIDARSAGENE AUTOTEMCEL
  • Treatment of metachromatic leukodystrophy (MLD)
  • Libmeldy
  • Libmeldy
  • Libmeldy
  • Other: Lysosomal storage Disorder
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100802-PIP01-22-M01 (update)
  • roxadustat
  • Treatment of anaemia due to chronic disorders
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • EVRENZO
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100727-PIP01-22-M01 (update)
  • ALPELISIB
  • Treatment of PIK3CA related overgrowth spectrum
  • Vijoice
  • Piqray
  • Vijoice
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100544-PIP01-22-M01 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100515-PIP01-22-M01 (update)
  • VORTIOXETINE
  • Treatment of Major Depressive Disorder
  • Brintellix
  • Brintellix
  • Brintellix
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023
MHRA-100392-PIP01-21-M03 (update)
  • TOZINAMERAN
  • TOZINAMERAN/ FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100580-PIP01-22-M01 (update)
  • CEMIPLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Cemiplimab
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100195-PIP01-21-M02 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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