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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-100078-PIP01-21-M02 (update)	AVIBACTAM AZTREONAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100618-PIP01-22-M01 (update)	AVIBACTAM CEFTAZIDIME	Treatment of intra-abdominal infections Treatment of urinary tract infections Treatment of pneumonia Treatment of infections due aerobic Gram-negative organisms.	Zavicefta	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100093-PIP01-21-M01 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis	Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100086-PIP01-21-M01 (update)	UPADACITINIB	Treatment of atopic dermatitis	Rinvoq	Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100093-PIP01-21-M02 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100093-PIP01-21-M03 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)	Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100112-PIP01-21	savolitinib	Treatment of renal neoplasms	Not available	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100084-PIP01-21-M01 (update)	MIDOSTAURIN	Treatment of acute myeloid leukaemia Malignant mastocytosis Mast cell leukaemia	Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules Rydapt® 25 mg soft capsules	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100089-PIP01-21-M01 (update)	dupilumab	Treatment of eosinophilic oesophagitis	Dupixent Dupixent Dupixent	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100090-PIP01-21-M01 (update)	DUPILUMAB	Treatment of atopic dermatitis	Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100251-PIP01-21	DUPILUMAB	Chronic pruritus of unknown origin	Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/02/2023
MHRA-100586-PIP01-22-M01 (update)	DUPILUMAB	Treatment of asthma	Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100586-PIP01-22-M02 (update)	DUPILUMAB	Treatment of asthma	Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100089-PIP01-21-M02 (update)	DUPILUMAB	Treatment of eosinophilic oesophagitis	Dupixent Dupixent	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	30/04/2024
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100118-PIP01-21-M01 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100118-PIP01-21-M02 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100119-PIP01-21-M01 (update)	TEZACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Symkevi Symkevi Symkevi	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100116-PIP01-21-M01 (update)	TEZACAFTOR ELEXACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Kaftrio Kaftrio Trikafta Kaftrio Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023

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