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Displaying 861 - 880 of 1030

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100816-PIP01-22-M01 (update)	crovalimab	Treatment of paroxysmal nocturnal haemoglobinuria Treatment of atypical haemolytic uremic syndrome		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100855-PIP01-23-M01 (update)	DOPAMINE HYDROCHLORIDE	Treatment of vascular hypotensive disorders	Neoatricon	Cardiovascular Diseases Neonatology - Paediatric Intensive Care	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	25/05/2023
MHRA-100657-PIP01-22-M01 (update)	BULEVIRTIDE	Treatment of chronic hepatitis D infection	Hepcludex Hepcludex Myrcludex B	Gastroenterology-Hepatology Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100627-PIP01-22-M01 (update)	Liposomal ciclosporin A (L-CsA)	Treatment of bronchiolitis obliterans syndrome (BOS)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100128-PIP01-21-M02 (update)	tiomolibdic acid	Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100632-PIP01-22-M01 (update)	FLUCICLOVINE (18F)	Diagnosis of amino acid metabolism in solid malignant tumours	Axumin Axumin Axumin Axumin Axumin Axumin Axumin Axumin	Diagnostic Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100609-PIP01-22-M01 (update)	LENVATINIB MESILATE	Treatment of papillary thyroid cancer and follicular thyroid cancer Treatment of osteosarcoma	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100761-PIP01-22-M01 (update)	NIVOLUMAB relatlimab	Treatment of melanoma	Opdualag Opdualag Opdualag Opdualag	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100571-PIP01-22-M01 (update)	TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection Treatment of chronic viral hepatitis B	Viread Viread Viread Viread Viread	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100340-PIP01-21-M02 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKZHYRO TAKZHRYO TAKHZYRO TAKHZYRO TAKHZYRO TAKZHYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100518-PIP01-22-M01 (update)	APREMILAST	Treatment of Behçet’s Disease	Otezla Otezla Otezla Otezla	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100505-PIP01-22-M01 (update)	copanlisib dihydrochloride	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) Treatment of mature B-cell neoplasms	Aliqopa Aliqopa Aliqopa Aliqopa Aliqopa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100637-PIP01-22	Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus	Treatment of chronic hepatitis D infection	Not available at present	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100316-PIP02-22	latozinemab	Treatment of Amyotrophic lateral sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100186-PIP01-21	depemokimab	Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)	Depemokimab	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100559-PIP01-22	mitapivat	Treatment of thalassaemia	PYRUKYND PYRUKYND	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100628-PIP01-22	Sibeprenlimab	Treatment of primary immunoglobulin A nephropathy		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100588-PIP01-22	UB-612	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present		P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100345-PIP01-21	Magrolimab	Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia) Treatment of acute myeloid leukaemia		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100508-PIP01-22	tezepelumab	Treatment of chronic spontaneous urticaria	Not available at present TEZSPIRE	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023

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