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Displaying 81 - 100 of 173
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100196-PIP01-21
  • SARS-CoV-2 virus, beta-propiolactone inactivated
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100196-PIP01-21
  • SARS-CoV-2 virus, beta-propiolactone inactivated
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100364-PIP01-21
  • Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100473-PIP01-22
  • Recombinant COVID-19 subunit nanoparticle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100470-PIP01-22
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100239-PIP01-21
  • multivalent pneumococcal polysaccharide conjugate vaccine
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100347-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory track disease caused by RSV via maternal immunisation.
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100242-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus.
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100030-PIP01-21
  • 9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)
  • Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100110-PIP02-22
  • Yellow fever virus, strain vYF-247
  • Prevention of yellow fever disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100966-PIP01-23
  • COVID-19 Vaccine (recombinant, adjuvanted)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100796-PIP01-22
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100096-PIP01-21
  • Live, attenuated, dengue virus, serotype 1 (DENV1)
  • Live, attenuated, chimeric dengue virus, serotype 2 (DENV2)
  • Live, attenuated, dengue virus, serotype 3 (DENV3)
  • Live, attenuated, dengue virus, serotype 4 (DENV4)
  • Prevention of dengue disease
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100754-PIP01-22
  • Live-attenuated La Reunion strain of chikungunya virus
  • Prevention of chikungunya virus disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100920-PIP01-23
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100680-PIP01-22
  • Influenza recombinant H7 haemagglutinin
  • Prevention of influenza infection
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100797-PIP01-22
  • Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)
  • Prevention of influenza disease
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100673-PIP01-22
  • Fidrisertib
  • Treatment of fibrodysplasia ossificans progressiva
  • Other: Musculoskeletal
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100678-PIP01-22
  • Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
  • Treatment of uveitic macular oedema
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100150-PIP01-21
  • AZITHROMYCIN
  • Prevention of bronchopulmonary dysplasia (BPD)
  • Pneumology - Allergology
  • Neonatology - Paediatric Intensive Care
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022