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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100405-PIP01-21-M01 (update)	LIRAGLUTIDE	Treatment of obesity	Saxenda Saxenda Saxenda	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100499-PIP01-22-M01 (update)	Giroctocogene Fitelparvovec	Treatment of haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100025-PIP01-21-M02 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100451-PIP01-22-M01 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100451-PIP01-22-M02 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100811-PIP01-22	Vamorolone	Treatment of Duchenne muscular dystrophy	AGAMREE	Other: Neuromuscular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100274-PIP01-21-M02 (update)	ELIGLUSTAT	Treatment of Gaucher Disease Type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100274-PIP01-21-M01 (update)	ELIGLUSTAT	Treatment of Gaucher Disease type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100463-PIP01-22-M01 (update)	spesolimab	Treatment of Generalised Pustular Psoriasis Prevention of Generalised Pustular Psoriasis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100485-PIP01-22-M01 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100505-PIP01-22-M01 (update)	copanlisib dihydrochloride	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) Treatment of mature B-cell neoplasms	Aliqopa Aliqopa Aliqopa Aliqopa Aliqopa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100518-PIP01-22-M01 (update)	APREMILAST	Treatment of Behçet’s Disease	Otezla Otezla Otezla Otezla	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100392-PIP01-21-M02 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100517-PIP01-22-M01 (update)	APREMILAST	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)	Otezla Otezla Otezla	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100532-PIP01-22-M02 (update)	BUROSUMAB	Treatment of X-linked Hypophosphataemia	Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita	Other: musculoskeletal disorder; osteology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100078-PIP01-21-M03 (update)	AZTREONAM AVIBACTAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100340-PIP01-21-M02 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKZHYRO TAKZHRYO TAKHZYRO TAKHZYRO TAKHZYRO TAKZHYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100571-PIP01-22-M01 (update)	TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection Treatment of chronic viral hepatitis B	Viread Viread Viread Viread Viread	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100543-PIP01-22-M01 (update)	LAMIVUDINE DOLUTEGRAVIR	Treatment of Human Immunodeficiency virus type 1 (HIV - 1) Infection	Dovato Dovato Dovato	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023

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