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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-101392-PIP01-24	Influenza Virus Type A, H1N1 Influenza Virus Type A, H3N2 Influenza Virus Type B, Victoria lineage	Prevention of influenza infection	Fluenz	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	24/06/2024
MHRA-101162-PIP01-23-M01 (update)	LETERMOVIR	Prevention of cytomegalovirus infection	PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PRVEYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS PREVYMIS tablet PREVYMIS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101234-PIP01-23-M01 (update)	ALIROCUMAB	Treatment of elevated cholesterol	Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent Praluent	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101293-PIP01-23-M01 (update)	METHOXYFLURANE	Treatment of acute pain	Penthrox	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101003-PIP01-23-M01 (update)	garadacimab	Prevention of hereditary angioedema		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	06/03/2024
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-101131-PIP01-23-M01 (update)	BLINATUMOMAB	Treatment of acute lymphoblastic leukaemia	BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCTYO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/01/2024
MHRA-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100642-PIP01-22-M02 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO Tremelimumab AstraZeneca	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-101149-PIP01-23-M01 (update)	elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)	Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)	Vimizim 1mg/ml concentrate for solution for infusion	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100098-PIP01-21-M02 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100741-PIP01-22	CRISANTASPASE	Treatment of acute lymphoblastic leukaemia Treatment of lymphoblastic lymphoma	Enrylaze Rylaze	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100844-PIP01-23-M01 (update)	IVACAFTOR	Treatment of cystic fibrosis.	Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	24/08/2023
MHRA-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100775-PIP01-22-M02 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	Livmarli (maralixibat chloride) LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	01/08/2023
MHRA-100553-PIP01-22-M01 (update)	REMIMAZOLAM BESYLATE	Sedation General Anaesthesia	Byfavo 20mg Anerem Byfavo Byfavo Byfavo	Anaesthesiology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100515-PIP01-22-M01 (update)	VORTIOXETINE	Treatment of Major Depressive Disorder	Brintellix Brintellix Brintellix	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100706-PIP01-22	METHYLPHENIDATE HYDROCHLORIDE	Treatment of attention-deficit hyperactivity disorder	Not available at present Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		30/06/2023
MHRA-100845-PIP01-23-M02 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	N/A VOCABRIA AND APRETUDE Apretude N/A N/A N/A Apretude Apretude	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	20/06/2023

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