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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-100470-PIP01-22-M01 (update)	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C 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	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100986-PIP01-23-M01 (update)	ENCORAFENIB	Treatment of melanoma	Braftovi Braftovi Bravtovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100985-PIP01-23-M01 (update)	BINIMETINIB	Treatment of melanoma	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100406-PIP01-21-M02 (update)	Marstacimab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100249-PIP01-21-M02 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma	Trixeo Aerosphere Trixeo Aerosphere Trixeo Aerosphere BREZTRI AEROSPHERE	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100625-PIP01-22-M01 (update)	RISANKIZUMAB	Treatment of psoriasis	Skyrizi Skyrizi Skyrizi Skyrizi	Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100409-PIP01-21-M01 (update)	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100327-PIP01-21-M02 (update)	SELPERCATINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100288-PIP01-21-M02 (update)	DENOSUMAB	Treatment of osteoporosis	Prolia Prolia	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100270-PIP01-21-M01 (update)	crinecerfont	Treatment of congenital adrenal hyperplasia		Endocrinology-Gynaecology-Fertility-metabolism	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-100758-PIP01-22-M01 (update)	BEZLOTOXUMAB	Prevention of recurrence of Clostridioides difficile infection	ZINPLAVA ZINPLAVA ZINPLAVA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100995-PIP01-23	LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)	Treatment of fibrosing Interstitial Lung Diseases (ILD)		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP04-23	Nipocalimab	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP03-23	Nipocalimab	Treatment of Sjögren’s syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100974-PIP01-23	BOTULINUM TOXIN TYPE A	Treatment of skin wrinkling	Not yet defined	Other: Aesthetics	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-100829-PIP01-22	Edaravone	Treatment of Amyotrophic lateral sclerosis	Not available at this moment	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100927-PIP01-23	Namilumab	Treatment of sarcoidosis	Not available at present	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023

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