PIP Search Page

Displaying 101 - 120 of 1097

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100238-PIP01-21-M02 (update)	AVELUMAB	Treatment of malignant neoplasms of the central nervous system Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) Treatment of malignant neoplasms of the lymphoid tissue.	Bavencio Bavencio Bavencio Bavencio	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/11/2024
MHRA-100916-PIP01-23-M02 (update)	ELUXADOLINE	Treatment of diarrhoea-predominant irritable bowel syndrome	Viberzi Viberzi Viberzi Viberzi Truberzi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/11/2024
MHRA-101422-PIP02-24	single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B and the N terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein. (mRNA-1083)	Prevention of influenza and coronavirus disease 2019 (COVID-19)	NA	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/11/2024
MHRA-101467-PIP01-24	apitegromab	Treatment of spinal muscular atrophy		Other: Neuromuscular disorders	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/11/2024
MHRA-100392-PIP01-21-M05 (update)	Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2) TOZINAMERAN TOZINAMERAN/FAMTOZINAMERAN TOZINAMERAN/RILTOZINAMERAN RAXTOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose dispersion for injection, single dose vial, COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 3 micrograms/dose 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.	Yes	29/11/2024
MHRA-101445-PIP01-24	CANNABIDIOL	Treatment of fragile X syndrome		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/11/2024
MHRA-100558-PIP01-22-M01 (update)	milvexian	Prevention of thromboembolism in patients with cardiovascular diseases		Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/11/2024
MHRA-101486-PIP01-24	Avalotcagene Ontaparvovec	Treatment of ornithine transcarbamylase deficiency	Not Yet Available		P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/11/2024
MHRA-101523-PIP01-24	Raludotatug deruxtecan	Treatment of Ovarian cancer Treatment of fallopian tube cancer Treatment of primary peritoneal cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024
MHRA-101497-PIP01-24	laruparetigene zovaparvovec Recombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR)	Treatment of X-linked retinitis pigmentosa (XLRP)	Not available at present	Ophthamology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/11/2024
MHRA-100492-PIP01-22-M02 (update)	MOLGRAMOSTIM	Treatment of pulmonary alveolar proteinosis	MOLBREEVI	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	28/11/2024
MHRA-101521-PIP01-24	Derivative of 6-(piperidine-1-carbonyl)pyridine-3-ol	Treatment of glomerulonephritis and nephrotic syndrome		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/11/2024
MHRA-101506-PIP01-24	Zongertinib	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024
MHRA-101482-PIP01-24-M01 (update)	BELATACEPT	Prevention of rejection of transplanted kidney	NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX NULOJIX	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	28/11/2024
MHRA-100247-PIP01-21-M02 (update)	BEROTRALSTAT DIHYDROCHLORIDE	Treatment of hereditary angioedema	Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	28/11/2024
MHRA-101489-PIP01-24	Enlicitide (decanoate)	Treatment of hypercholesterolemia		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/11/2024
MHRA-101442-PIP01-24	Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)	Treatment of urothelial carcinoma Treatment of cutaneous squamous cell carcinoma Treatment of renal cell carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024
MHRA-101384-PIP01-24	Telisotuzumab adizutecan	Treatment of colorectal carcinoma.		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024
MHRA-101500-PIP01-24	Zanidatamab	Treatment of gastroesophageal adenocarcinoma (GEA).		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024
MHRA-101499-PIP01-24	Zanidatamab	Treatment of HER2-positive breast cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/11/2024

Download XLSX

Search Filters: