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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100335-PIP01-21-M01 (update)	Erdafitinib	Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasm)	BALVARSA BALVERSA ERFANDEL tablet BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100711-PIP01-22-M01 (update)	TISAGENLECLEUCEL	Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma	Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion Kymriah Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100567-PIP01-22-M01 (update)	Dinutuximab beta	Treatment of neuroblastoma	Qarziba Qarziba	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100565-PIP01-22	MDM2-p53 antagonist	Treatment of liposarcoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100555-PIP01-22	vepsitamab	Treatment of gastric cancer and gastro-oesophageal junction cancer Treatment of colorectal carcinoma Treatment of pancreatic cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100583-PIP01-22	SACITUZUMAB GOVITECAN	Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)	Trodelvy Trodelvy Trodelvy	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100602-PIP01-22	monalizumab	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100603-PIP01-22	Oleclumab	Treatment of lung cancer Treatment of pancreatic cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100598-PIP01-22	Cobolimab	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100466-PIP01-22	zilovertamab vedotin	Treatment of malignant neoplasms of haematopoietic and lymphoid tissue Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)	not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100792-PIP01-22	OBINUTUZUMAB	Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies	Gazyvaro	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100719-PIP01-22	LUTETIUM (177LU) OXODOTREOTIDE	Treatment of gastroenteropancreatic neuroendocrine tumours	Lutathera 370 MBq/mL solution for infusion Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100580-PIP01-22-M01 (update)	CEMIPLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Cemiplimab	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100148-PIP01-21-M03 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma	Lenvima Lenvima Kisplyx Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100740-PIP01-22	Xevinapant	Treatment of head and neck epithelial malignant neoplasms	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/06/2023
MHRA-100641-PIP01-22-M02 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	14/08/2023
MHRA-100788-PIP01-22	favezelimab PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Not availble at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100738-PIP01-22	PEMIGATINIB	Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement	Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100687-PIP01-22-M01 (update)	OBINUTUZUMAB	Treatment of systemic lupus erythematosus	Gazyvaro Gazyvaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100268-PIP01-21-M02 (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	24/08/2023

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