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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-100428-PIP01-22-M02 (update)	LENACAPAVIR SODIUM	Treatment of human immunodeficiency virus (HIV-1) infection	Sunlenca Sunlenca	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-101431-PIP01-24	SODIUM PHENYLBUTYRATE Ursodoxicoltaurine	Treatment of progressive supranuclear palsy	Relyvrio Albrioza	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101388-PIP01-24-M01 (update)	DARIDOREXANT HYDROCHLORIDE	Treatment of insomnia.	QUVIVIQ	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-101326-PIP01-24	Human IgG4 monoclonal antibody against BCMA and CD3	Treatment of multiple myeloma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101338-PIP01-24	elinzanetant	Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer		Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101335-PIP01-24-M01 (update)	LANDIOLOL HYDROCHLORIDE	Treatment of supraventricular arrhythmias.	Rapibloc Rapibloc Rapibloc	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		03/10/2024
MHRA-101186-PIP01-23	FARICIMAB	Treatment of choroidal neovascularisation secondary to pathologic myopia	Vabysmo Vabysmo	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101324-PIP01-23-M01 (update)	REGADENOSON	Diagnosis of myocardial perfusion disturbances	Rapiscan Rapiscan Rapiscan	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-101288-PIP01-23	Interleukin-2 Interleukin-1 beta, human Granulocyte colony-stimulating factor Tumor necrosis factor-alpha Interferon gamma	Treatment of squamous cell carcinoma of the head and neck (SCCHN)	Multikine	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101007-PIP01-23	tiragolumab ATEZOLIZUMAB	Treatment of lung carcinoma (non-small cell carcinoma)	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-100968-PIP01-23	dirloctocogene samoparvovec	Treatment of congenital haemophilia A	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		03/10/2024
MHRA-101204-PIP01-23	Ravulizumab (ALXN1210)	Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass	Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-100494-PIP01-22-M02 (update)	NIVOLUMAB	Treatment of malignant neoplasms of lymphoid tissue Treatment of malignant neoplasms of the central nervous system	OPDIVO OPDIVO OPDIVO OPDIVO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-100502-PIP01-22-M02 (update)	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)	Prevention of influenza disease	Supemtek	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-101127-PIP01-23	Zimberelimab	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101126-PIP01-23	Zimberelimab	Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		03/10/2024
MHRA-101400-PIP01-24	nirogacestat hydrobromide	Treatment of soft tissue sarcoma	Not yet available in the United Kingdom (Ogsiveo in the United States and European Union). Ogsiveo	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		03/10/2024
MHRA-101492-PIP01-24	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (RIV3)	Prevention of influenza disease	Flublok	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	03/10/2024
MHRA-100086-PIP01-21-M02 (update)	UPADACITINIB	treatment of atopic dermatitis	Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq	Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024
MHRA-100921-PIP01-23-M04 (update)	AVATROMBOPAG MALEATE	Treatment of Idiopathic Thrombocytopenia Purpura Treatment of Thrombocytopenic Purpura Secondary to Liver Disease	Doptelet Doptelet	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/10/2024

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