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Displaying 901 - 920 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-100105-PIP01-21	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100115-PIP01-21	Dersimelagon	Treatment of erythropoietic protoporphyria Treatment of X-linked protoporphyria	Not available at present	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100409-PIP01-21	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100525-PIP01-22-M01 (update)	TILDRAKIZUMAB	Treatment of psoriasis	Ilumetri 100 mg solution for injection in pre-filled syringe Ilumetri 100 mg solution for injection in pre-filled syringe ILUMYA ILUMYA ILUMYA Ilumetri 100 mg solution for injection in pre-filled syringe Ilumetri	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100521-PIP01-22-M01 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100190-PIP01-21	Ordesekimab	Treatment of coeliac disease		Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No		29/07/2022
MHRA-100122-PIP01-21	olpasiran	Prevention of cardiovascular events		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		29/07/2022
MHRA-100494-PIP01-22-M01 (update)	NIVOLUMAB	Malignant neoplasms of lymphoid tissue Malignant neoplasms of the central nervous system	OPDIVO OPDIVO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100450-PIP01-22-M01 (update)	ALPELISIB	PIK3CA Related Overgrowth Spectrum (PROS)	Piqray Piqray	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100428-PIP01-22-M01 (update)	Lenacapavir	Treatment of human immunodeficiency virus (HIV-1) infection		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100237-PIP01-21-M01 (update)	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage) Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Prevention of influenza infection	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe) Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100349-PIP01-21-M01 (update)	Rezafungin acetate	Treatment of invasive candidiasis	Rezafungin 200 mg powder for concentrate for solution for infusion	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100336-PIP01-21-M01 (update)	soticlestat	Treatment of Dravet Syndrome Lennox-Gastaut Syndrome		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100294-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of asthma	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100308-PIP01-21-M01 (update)	AZILSARTAN MEDOXOMIL	Treatment of hypertension	Edarbi Edarbi	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100303-PIP01-21-M01 (update)	DARUNAVIR COBICISTAT EMTRICITABINE TENOFOVIR ALAFENAMIDE	Treatment of human immunodeficiency virus type-1 (HIV-1) infection	Symtuza Symtuza Symtuza Symtuza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100289-PIP01-21-M01 (update)	GALCANEZUMAB	Prevention of migraine headaches	Emgality Emgality Emgality	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100259-PIP01-21-M01 (update)	DULAGLUTIDE	Treatment of Type 2 Diabetes Mellitus	Trulicity Trulicity	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100252-PIP01-21-M01 (update)	GEMTUZUMAB OZOGAMICIN	Treatment of acute myeloid leukaemia	Mylotarg Mylotarg 16/06/2019 Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg Mylotarg	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100250-PIP01-21-M01 (update)	VERICIGUAT	Treatment of left ventricular failure	Verquvo Verquvo Verquvo Verquvo	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022

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