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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100722-PIP01-22	Ritlecitinib	Treatment of vitiligo		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-101058-PIP01-23	SIROLIMUS	Treatment of Tuberous Sclerosis	Pascomer	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100276-PIP01-21-M03 (update)	BRODALUMAB	Treatment of psoriasis	Kyntheum Kyntheum Lumicef Siliq Kyntheum Kyntheum Kyntheum	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100044-PIP01-21	seltorexant	Treatment of major depressive disorder (MDD)	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/03/2022
MHRA-100253-PIP01-21	Zuranolone	Treatment of post-partum depression		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		07/12/2022
MHRA-100398-PIP01-21	ralmitaront	Treatment of schizophrenia		Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		07/12/2022
MHRA-100395-PIP01-21	TALAZOPARIB TOSYLATE	Treatment of breast malignant neoplasms Treatment of prostate malignant neoplasms	Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna	Psychiatry Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100430-PIP01-22	±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)	Treatment of post-traumatic stress disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100593-PIP01-22	aticaprant	Treatment of Major Depressive Disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No		18/03/2022
MHRA-100050-PIP01-21	efgartigimod alfa	Treatment of Immune thrombocytopenia		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100140-PIP01-21	BENRALIZUMAB	Treatment of Hypereosinophilic syndrome (HES)	FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100266-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of sickle cell disease		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100267-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of beta-thalassemia intermedia and major		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100372-PIP01-21	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022

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