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Displaying 881 - 900 of 1097

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100260-PIP01-21-M01 (update)	CEMIPLIMAB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Libtayo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100238-PIP01-21-M01 (update)	AVELUMAB	Treatment of malignant neoplasms of the CNS, lymphoid tissue and other malignant neoplasms.	Bavencio Bavencio Bavencio Bavencio Bavencio	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100258-PIP01-21-M01 (update)	Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus	Not available yet	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100240-PIP01-21-M01 (update)	BOSUTINIB	Treatment of chronic myeloid leukaemia (CML)	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100158-PIP01-21-M01 (update)	PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Keytruda Keytruda	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
MHRA-100162-PIP01-21-M01 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100487-PIP01-22	exebacase	Treatment of Staphylococcus aureus bacteraemia		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100454-PIP01-22	adagrasib	Treatment of all solid and haematological malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100332-PIP01-21	sotatercept	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100374-PIP01-21	Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene	Treatment of frontotemporal dementia		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100382-PIP01-21	RAVULIZUMAB	Treatment of myasthenia gravis	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100335-PIP01-21	erdafitinib	Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)	BALVERSA BALVERSA ERFANDEL BALVERSA	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100295-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).	Treatment of polymyalgia rheumatica		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No		27/09/2022
MHRA-100218-PIP01-21	DUPILUMAB	Treatment of chronic spontaneous urticaria	Dupixent Dupixent	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100226-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154	Treatment of chronic idiopathic arthritis (rheumatoid, psoriatic, JIA, ankylosing spondylitis)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100178-PIP01-21	DTX401 (a nonreplicating, recombinant adeno-associated virus serotype 8 vector that contains a codon-optimized, wild-type human glucose-6-phosphatase (G6PC) gene)	Treatment of glycogen storage disease type 1a (GSDIa)	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100141-PIP01-21	BENRALIZUMAB	Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN	Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100151-PIP01-21	CANNABIDIOL	Treatment of epilepsy with myoclonic-atonic seizures (EMAS)	Epidyolex Epidyolex Epidyolex Epidiolex Epidyolex Epidyolex Epidiolex	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022

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