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PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100865-PIP01-23-M01 (update)	RILPIVIRINE	Treatment of human immunodeficiency virus (HIV-1) infection	REKAMBYS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100657-PIP01-22-M01 (update)	BULEVIRTIDE	Treatment of chronic hepatitis D infection	Hepcludex Hepcludex Myrcludex B	Gastroenterology-Hepatology Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100627-PIP01-22-M01 (update)	Liposomal ciclosporin A (L-CsA)	Treatment of bronchiolitis obliterans syndrome (BOS)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100610-PIP01-22-M01 (update)	ECULIZUMAB	Treatment of myasthenia gravis	SOLIRIS SOLIRIS	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100128-PIP01-21-M02 (update)	tiomolibdic acid	Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100351-PIP01-21-M01 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA JULUCA JULUCA JASUPA Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-101053-PIP01-23-M01 (update)	DOLUTEGRAVIR ABACAVIR LAMIVUDINE	Treatment of human immunodeficiency virus (HIV-1) infection	TRIUMEQ TRIUMEQ	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/01/2024
MHRA-100351-PIP01-21-M02 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JASUPA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100543-PIP01-22-M02 (update)	DOLUTEGRAVIR LAMIVUDINE	Treatment of Human Immunodeficiency virus (HIV - 1) Infection	Dovato Dovato Dovato	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
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-100630-PIP01-22-M01 (update)	PATIROMER SORBITEX CALCIUM	Treatment of hyperkalaemia	Veltassa	Other: Nephrology/Metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100552-PIP01-22-M01 (update)	RILPIVIRINE HYDROCHLORIDE	Treatment of human immunodeficiency virus (HIV-1) infection	edurant edurant	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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-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-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-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-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-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-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

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