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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Date Published
MHRA-100471-PIP01-22-M01 (update)	SETMELANOTIDE	Treatment of appetite and general nutrition disorders	IMCIVREE IMCIVREE IMCIVREE IMCIVREE	Nutrition	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100114-PIP01-21	BARICITINIB	Treatment of coronavirus disease 2019 (COVID-19)	Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant Olumiant	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/11/2021
MHRA-100022-PIP01-21	bimekizumab	Hidradenitis suppurativa		Immunology -Rheumatology-Transplantation Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/11/2021
MHRA-100160-PIP01-21-M01 (update)	TOCILIZUMAB	Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy	RoActemra RoActemra	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100093-PIP01-21-M01 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis	Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100086-PIP01-21-M01 (update)	UPADACITINIB	Treatment of atopic dermatitis	Rinvoq	Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100135-PIP01-21	anti-CD40L humanized monoclonal antibody (SAR441344)	Treatment of Sjogren's Syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100265-PIP01-21	BARICITINIB	Treatment of alopecia areata	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100293-PIP01-21	lenzilumab	Treatment of coronavirus disease 2019 (COVID-19)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100304-PIP01-21	rozibafusp alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation Other: Inflammation-Rheumatology SLE	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100123-PIP01-21-M01 (update)	SARILUMAB	Treatment of chronic idiopathic arthritis	Kevzara Kevzara Kevzara Kevzara Kevzara	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
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-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
MHRA-100019-PIP01-21	2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT	Treatment of chronic Graft versus Host Disease (cGVHD)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/10/2022
MHRA-100075-PIP01-21	leniolisib	Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100321-PIP01-21-M01 (update)	GUSELKUMAB	Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100361-PIP01-21-M01 (update)	GOLIMUMAB	Treatment of ulcerative colitis	Simponi 50 mg solution for injection in pre-filled pen Simponi 50 mg solution for injection in pre-filled syringe Simponi 100 mg solution for injection in pre-filled pen Simponi 45 mg/0.45 mL solution for injection in pre-filled pen Simponi Simponi Simponi Simponi Simponi Simponi Simponi Simponi	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100511-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of Crohn's disease	TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100421-PIP01-22	efavaleukin alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100093-PIP01-21-M02 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023

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