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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100450-PIP01-22-M01 (update)	ALPELISIB	PIK3CA Related Overgrowth Spectrum (PROS)	Piqray Piqray	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100521-PIP01-22-M01 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100521-PIP01-22-M02 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100332-PIP01-21-M01 (update)	sotatercept	Treatment of pulmonary arterial hypertension	Not available at present	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		24/08/2023
MHRA-100162-PIP01-21-M02 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
MHRA-100240-PIP01-21-M04 (update)	BOSUTINIB	Treatment of chronic myeloid leukemia	Bosulif Bosulif	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
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-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100075-PIP01-21-M01 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100075-PIP01-21-M02 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja Joenja Joenja Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100343-PIP01-21-M03 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension Treatment of systemic sclerosis Treatment of idiopathic pulmonary fibrosis.	Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100236-PIP01-21-M03 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Prevention of disease caused by Streptococcus pneumoniae	Apexxnar Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100340-PIP01-21-M01 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		07/12/2022
MHRA-100447-PIP01-22-M01 (update)	tirzepatide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-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-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-100608-PIP01-22-M01 (update)	mitapivat	Treatment of pyruvate kinase deficiency	PYRUKYND PYRUKYND	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100623-PIP01-22-M01 (update)	NIRAPARIB TOSYLATE MONOHYDRATE	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Zejula Zejula Zejula Zejula	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022

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