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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100829-PIP01-22	Edaravone	Treatment of Amyotrophic lateral sclerosis	Not available at this moment	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
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-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-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-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-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
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-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-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-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-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

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