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Displaying 21 - 40 of 173
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-100446-PIP01-22
  • Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one
  • Treatment of Chronic Kidney Disease
  • Uro-Nephrology
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-100840-PIP01-23
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100885-PIP01-23
  • Iptacopan
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Not available at present; Product code: LNP023
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 19/12/2023
MHRA-100787-PIP01-22
  • Repotrectinib
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
  • Not available at present
  • Oncology
  • Other: Not Applicable
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 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-100919-PIP01-23
  • Bepirovirsen
  • Treatment of chronic hepatitis B infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100299-PIP01-21
  • Humanized monoclonal IgG1-based antibody
  • Treatment of spinal muscular atrophy
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
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-100573-PIP01-22
  • Vorasidenib
  • Treatment of glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
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-100741-PIP01-22
  • CRISANTASPASE
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
  • Enrylaze
  • Rylaze
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 19/12/2023
MHRA-100679-PIP01-22
  • Talazoparib
  • Treatment of Ewing Sarcoma
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2023
MHRA-100824-PIP01-22
  • perflubutane
  • Diagnostic evaluation of focal hepatic lesions
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Diagnostic
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100670-PIP01-22
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100612-PIP01-22
  • Fosmanogepix
  • Treatment of invasive fungal infections
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100788-PIP01-22
  • favezelimab
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Not availble at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100721-PIP01-22
  • Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023