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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-100917-PIP01-23	Active Substance efgartigimod alfa	Conditions / Indications Treatment of Bullous Pemphigoid	Invented Name Vyvgart Vyvgart Vyvgart Vyvgart	Therapeutic area Dermatology	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-100927-PIP01-23	Active Substance Namilumab	Conditions / Indications Treatment of sarcoidosis	Invented Name Not available at present	Therapeutic area Immunology -Rheumatology-Transplantation	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-100850-PIP01-23	Active Substance deucravacitinib	Conditions / Indications Treatment of Sjogren's Syndrome	Invented Name SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Therapeutic area Immunology -Rheumatology-Transplantation	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-100874-PIP01-23	Active Substance PEMBROLIZUMAB	Conditions / Indications Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Invented Name Keytruda	Therapeutic area Oncology	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-100848-PIP01-23	Active Substance messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene	Conditions / Indications Treatment for transthyretin amyloidosis (ATTR)	Invented Name Not available at present	Therapeutic area Neurology Cardiovascular Diseases	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-100873-PIP01-23	Active Substance Meningococcal Group A, C, W-135 and Y conjugate vaccine	Conditions / Indications Meningococcal meningitis	Invented Name Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo	Therapeutic area Vaccines	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-101019-PIP01-23	Active Substance Treprostinil Palmitil	Conditions / Indications Treatment of pulmonary hypertension due to lung disease and/or hypoxia.	Invented Name Not available at present	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-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-100885-PIP01-23	Active Substance Iptacopan	Conditions / Indications Treatment of paroxysmal nocturnal haemoglobinuria (PNH)	Invented Name Not available at present; Product code: LNP023	Therapeutic area Haematology-Hemostaseology Other: Complement-driven renal disease	Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Compliance Check Yes	Compliance outcome Partial Compliance Check Granted	Date Published Sort ascending 19/12/2023
PIP Number MHRA-100787-PIP01-22	Active Substance Repotrectinib	Conditions / Indications Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)	Invented Name Not available at present	Therapeutic area Oncology Other: Not Applicable	Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Compliance Check Yes	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

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