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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100557-PIP01-22-M01 (update)	Hepatitis B (rDNA) surface antigen adjuvanted	Prevention of hepatitis B virus infection	HEPLISAV B HEPLISAV-B HEPLISAV-B HEPLISAV B	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100564-PIP01-22-M01 (update)	TEDIZOLID PHOSPHATE	Treatment of acute bacterial skin and skin structure infections	Sivextro Sivextro Sivextro Sivextro Sivextro Sivextro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100501-PIP01-22-M01 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100028-PIP01-21-M01 (update)	TIXAGEVIMAB CILGAVIMAB	Prevention of Coronavirus Disease 2019 (COVID-19) Treatment of COVID-19	Evusheld Evusheld Evusheld	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100522-PIP01-22-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cometriq Cabometyx Cabometyx Cometriq	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100535-PIP01-22-M01 (update)	UMECLIDINIUM BROMIDE FLUTICASONE FUROATE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta/ Elebrato/Temybric Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100479-PIP01-22-M01 (update)	POSACONAZOLE	Prevention of invasive fungal infections Treatment of invasive fungal infections	Noxafil Noxafil Noxafil Noxafil Noxafil	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100524-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100523-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100148-PIP01-21-M02 (update)	LENVATINIB MESILATE	Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma	Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100507-PIP01-22-M01 (update)	BREXPIPRAZOLE	Treatment of schizophrenia	RXULTI RXULTI	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100492-PIP01-22-M01 (update)	MOLGRAMOSTIM	Treatment of pulmonary alveolar proteinosis	Not available at present	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		07/12/2022
MHRA-100502-PIP01-22-M01 (update)	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)	Prevention of influenza infection	Supemtek Supemtek	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		07/12/2022
MHRA-100476-PIP01-22	Anti-(alpha-synuclein) human monoclonal antibody	Treatment of Multiple System Atrophy Treatment of Parkinson's Disease		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100481-PIP01-22	TUCATINIB	Treatment of solid tumours	Tukysa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100404-PIP01-21	insulin icodec SEMAGLUTIDE	Treatment of type 2 diabetes mellitus		Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022
MHRA-100365-PIP01-21	Batiraxcept	Treatment of Ovarian cancer Treatment of Fallopian tube cancer Treatment of Primary peritoneal cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(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-100366-PIP01-21	Cevostamab	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		07/12/2022

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