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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100851-PIP01-23 -M01 (update)	NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Recombinant Neisseria meningitidis serogroup B protein 1 Recombinant Neisseria meningitidis serogroup B protein 2 Recombinant Neisseria meningitidis serogroup B Protein-based active substance Recombinant Neisseria meningitidis serogroup B protein 3	Prevention of meningococcal disease (serogroups A, B, C, W and Y)		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	09/04/2025
MHRA-100129-PIP01-21-M02 (update)	Cipaglucosidase alfa	Treatment of glycogen storage disease Type II (Pompe's disease)	Pombiliti Pombilti Pombiliti	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-101694-PIP01-24	Human IgG1 monoclonal antibody targeting amyloid transthyretin	Treatment of transthyretin-mediated amyloidosis		Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-100823-PIP01-22-M03 (update)	Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)	Treatment of thrombotic thrombocytopenic purpura		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-100698-PIP01-22-M01 (update)	nemvaleukin alfa	Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue) Treatment of malignant neoplasms of the lymphoid tissue		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-100105-PIP01-21-M02 (update)	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-101542-PIP01-24	lutikizumab	Treatment of hidradenitis suppurativa		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	08/04/2025
MHRA-100050-PIP01-21-M02 (update)	efgartigimod alfa	Treatment of Immune thrombocytopenia	Vyvgart Vyvgart Vyvgart Vyvgart Vyvgart	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-101595-PIP01-24	efinopegdutide	Treatment of metabolic dysfunction-associated steatohepatitis		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	08/04/2025
MHRA-101488-PIP01-24	etavopivat	Treatment of sickle cell disease	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	08/04/2025
MHRA-101664-PIP01-24	SECUKINUMAB	Treatment of polymyalgia rheumatica	Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx Cosentyx	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-101654-PIP01-24	Volrustomig	Treatment of head and neck epithelial malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-101605-PIP01-24	Telisotuzumab adizutecan	Treatment of lung carcinoma (small cell and non-small cell carcinoma)		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-101702-PIP01-24	Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)	Treatment of melanoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-101457-PIP01-24	Acasunlimab	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	08/04/2025
MHRA-101435-PIP01-24	Hemopexin, human	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	08/04/2025
MHRA-101314-PIP01-23	Venglustat	Treatment of Gaucher Disease Type 2 Treatment of Gaucher Disease type 3		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	08/04/2025
MHRA-100468-PIP01-22-M03 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti VYEPTI 100 mg concent rate for solution for infusion VYEPTI 300 mg concent rate for solution for infusion	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-100200-PIP01-21-M02 (update)	REGORAFENIB	Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)	Stivarga Stivarga	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025
MHRA-101767-PIP01-24-M01 (update)	TOFACITINIB CITRATE	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis).	XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	08/04/2025

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