Displaying 641 - 660 of 773
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100801-PIP01-22
  • eplontersen
  • Treatment of transthyretin-mediated amyloidosis
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100776-PIP01-22-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis.
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100897-PIP01-23-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-100212-PIP01-21-M02 (update)
  • FINERENONE
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100786-PIP01-22-M01 (update)
  • TOFACITINIB CITRATE
  • Treatment of ulcerative colitis
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100823-PIP01-22-M01 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura
  • rADAMTS13
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/08/2023
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-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-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-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-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-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-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-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-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-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-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-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-100933-PIP01-23
  • camlipixant
  • Treatment of unexplained or chronic refractory cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(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