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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100927-PIP01-23	Namilumab	Treatment of sarcoidosis	Not available at present	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100850-PIP01-23	deucravacitinib	Treatment of Sjogren's Syndrome	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100874-PIP01-23	PEMBROLIZUMAB	Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Keytruda	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100848-PIP01-23	messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene	Treatment for transthyretin amyloidosis (ATTR)	Not available at present	Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100873-PIP01-23	Meningococcal Group A, C, W-135 and Y conjugate vaccine	Meningococcal meningitis	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	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-101019-PIP01-23	Treprostinil Palmitil	Treatment of pulmonary hypertension due to lung disease and/or hypoxia.	Not available at present	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100882-PIP01-23	Glucagon analogue linked to a human immunoglobulin Fc fragment	Treatment of congenital hyperinsulinism		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100957-PIP01-23	deucravacitinib	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100722-PIP01-22	Ritlecitinib	Treatment of vitiligo		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100809-PIP01-22	Efruxifermin	Treatment of non-alcoholic steatohepatitis (NASH)	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
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-100894-PIP01-23	depemokimab	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)		Pneumology - Allergology	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-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-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

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