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Displaying 461 - 480 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
PIP Number MHRA-100882-PIP01-23 Active Substance
  • Glucagon analogue linked to a human immunoglobulin Fc fragment
Conditions / Indications
  • Treatment of congenital hyperinsulinism
Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100957-PIP01-23 Active Substance
  • deucravacitinib
Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100722-PIP01-22 Active Substance
  • Ritlecitinib
Conditions / Indications
  • Treatment of vitiligo
Invented Name Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100809-PIP01-22 Active Substance
  • Efruxifermin
Conditions / Indications
  • Treatment of non-alcoholic steatohepatitis (NASH)
Invented Name
  • Not available at present
Therapeutic area
  • Gastroenterology-Hepatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100754-PIP01-22 Active Substance
  • Live-attenuated La Reunion strain of chikungunya virus
Conditions / Indications
  • Prevention of chikungunya virus disease
Invented Name Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100894-PIP01-23 Active Substance
  • depemokimab
Conditions / Indications
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100446-PIP01-22 Active Substance
  • Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one
Conditions / Indications
  • Treatment of Chronic Kidney Disease
Invented Name Therapeutic area
  • Uro-Nephrology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100933-PIP01-23 Active Substance
  • camlipixant
Conditions / Indications
  • Treatment of unexplained or chronic refractory cough
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100678-PIP01-22 Active Substance
  • Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
Conditions / Indications
  • Treatment of uveitic macular oedema
Invented Name
  • Not available at present
Therapeutic area
  • Ophthamology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100840-PIP01-23 Active Substance
  • Odronextamab
Conditions / Indications
  • Treatment of mature B cell malignancies
Invented Name Therapeutic area
  • Oncology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100096-PIP01-21 Active Substance
  • 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)
Conditions / Indications
  • Prevention of dengue disease
Invented Name
  • Not available at present
Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100919-PIP01-23 Active Substance
  • Bepirovirsen
Conditions / Indications
  • Treatment of chronic hepatitis B infection
Invented Name Therapeutic area
  • Infectious diseases
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100299-PIP01-21 Active Substance
  • Humanized monoclonal IgG1-based antibody
Conditions / Indications
  • Treatment of spinal muscular atrophy
Invented Name
  • Not available at present
Therapeutic area
  • Neurology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100796-PIP01-22 Active Substance
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
Conditions / Indications
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
Invented Name
  • Not available at present
Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100573-PIP01-22 Active Substance
  • Vorasidenib
Conditions / Indications
  • Treatment of glioma
Invented Name Therapeutic area
  • Oncology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100673-PIP01-22 Active Substance
  • Fidrisertib
Conditions / Indications
  • Treatment of fibrodysplasia ossificans progressiva
Invented Name Therapeutic area
  • Other: Musculoskeletal
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100731-PIP01-22 Active Substance
  • deucravacitinib
Conditions / Indications
  • Treatment of systemic lupus erythematosus
Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100679-PIP01-22 Active Substance
  • Talazoparib
Conditions / Indications
  • Treatment of Ewing Sarcoma
Invented Name
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
Therapeutic area
  • Oncology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100102-PIP01-21-M02 (update) Active Substance
  • INDACATEROL ACETATE
  • MOMETASONE FUROATE
Conditions / Indications
  • Treatment of asthma
Invented Name
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler
Therapeutic area
  • Pneumology - Allergology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100095-PIP01-21-M03 (update) Active Substance
  • DORAVIRINE
Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
Invented Name
  • Pifeltro
Therapeutic area
  • Infectious diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending