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Displaying 201 - 220 of 692

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100716-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of chronic Graft versus Host Disease	Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100959-PIP01-23-M01 (update)	DOSTARLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Jemperli Jemperli Jemperli	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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
MHRA-100806-PIP01-22	ALPELISIB	Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Peritoneal cancer (excluding blastomas and sarcomas).	Piqray Piqray	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/08/2023
MHRA-100679-PIP01-22	Talazoparib	Treatment of Ewing Sarcoma	Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		03/10/2023
MHRA-100741-PIP01-22	CRISANTASPASE	Treatment of acute lymphoblastic leukaemia Treatment of lymphoblastic lymphoma	Enrylaze Rylaze	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100573-PIP01-22	Vorasidenib	Treatment of glioma		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100787-PIP01-22	Repotrectinib	Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)	Not available at present	Oncology Other: Not Applicable	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		19/12/2023
MHRA-100840-PIP01-23	Odronextamab	Treatment of mature B cell malignancies		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100874-PIP01-23	PEMBROLIZUMAB	Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Keytruda	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100834-PIP01-23	SOTORASIB	Treatment of colorectal carcinoma	Lumykras Lumykras	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100289-PIP01-21-M03 (update)	GALCANEZUMAB	Prevention of migraine headache	Emgality Emgality Emgality Emgality Emgality Emgality	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101079-PIP01-23-M01 (update)	ZANUBRUTINIB	Treatment of lymphoplasmacytic lymphoma Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)	Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100352-PIP01-21-M02 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023

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