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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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 03/10/2023
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 25/08/2023
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 24/08/2023

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