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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
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-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-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-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-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

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