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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100724-PIP01-22	tozorikamab	Treatment of severe viral lower respiratory tract infection		Pneumology - Allergology Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	15/08/2024
MHRA-100723-PIP01-22	Wisconsin modRNA (PF-07829855) Austria modRNA (PF-07872963) Darwin modRNA (PF-07871853) Phuket modRNA (PF-07836259)	Prevention of influenza disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	15/08/2024
MHRA-101286-PIP01-23	Varicella virus Oka strain (live, attenuated)	Prevention of varicella	Not Applicable	Infectious diseases Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/06/2024
MHRA-100084-PIP01-21-M02 (update)	MIDOSTAURIN	Treatment of acute myeloid leukaemia Treatment of malignant mastocytosis Treatment of mast cell leukaemia.	Rydapt Rydapt	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101336-PIP01-24-M01 (update)	DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 3 SURFACE PROTEINS LIVE ATTENUATED DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 4 SURFACE PROTEINS LIVE ATTENUATED DENGUE VIRUS SEROTYPE 2 LIVE ATTENUATED	Prevention of dengue fever	Qdenga Qdenga Qdenga Qdenga Qdenga Qdenga Qdenga Qdenga powder and solvent for solution for injection Qdenga powder and solvent for solution for injection in pre-filled syringe		PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101289-PIP01-23-M01 (update)	Remibrutinib	Treatment of chronic spontaneous urticaria.		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100951-PIP01-23-M03 (update)	FOSTEMSAVIR TROMETHAMINE	Treatment of Human immunodeficiency virus (HIV-1) infection	RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101283-PIP01-23-M01 (update)	Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues	Treatment of congenital haemophilia A Treatment of congenital haemophilia B.		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100364-PIP01-21-M01 (update)	Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E	Prevention of lower respiratory tract disease caused by respiratory syncytial virus	Arexvy Arexvy	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100116-PIP01-21-M03 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of Cystic Fibrosis	Kaftrio	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101097-PIP01-23-M01 (update)	Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)	Prevention of smallpox, mpox and related orthopoxvirus infection and disease	Imvanex Imvanex Imvamune Jynneos Imvanex	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101097-PIP01-23-M01 (update)	Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)	Prevention of smallpox, mpox and related orthopoxvirus infection and disease	Imvanex Imvanex Imvamune Jynneos Imvanex	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100604-PIP01-22-M02 (update)	REMDESIVIR	Treatment of coronavirus disease 2019 (COVID-19)	VEKLURY VEKLURY	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101250-PIP01-23-M01 (update)	RISANKIZUMAB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)	Skyrizi Skyrizi Skyrizi Skyrizi Skyrizi Skyrizi Skyrizi Skyrizi	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101233-PIP01-23-M01 (update)	inebilizumab	Treatment of neuromyelitis optica spectrum disorders	Uplizna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-101093-PIP01-23-M01 (update)	satralizumab	Treatment of neuromyelitis optica.	Enspryng Enspryng	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100283-PIP01-21-M03 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100209-PIP01-21-M01 (update)	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of obesity	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100445-PIP01-22-M01 (update)	RAVULIZUMAB	Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).	Ultomiris Ultomiris Ultomiris	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024
MHRA-100214-PIP01-21-M04 (update)	RAVULIZUMAB	Treatment of atypical haemolytic uremic syndrome.	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomriris Ultomriris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/06/2024

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