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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort descending
MHRA-100392-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersio n for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100391-PIP01-21-M01 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100390-PIP01-21-M01 (update)	Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/04/2022
MHRA-100276-PIP01-21-M01 (update)	BRODALUMAB	Treatment of psoriasis	brodalumab Lumicef Siliq Kyntheum	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
MHRA-100052-PIP01-21-M01 (update)	CASIRIVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
MHRA-100053-PIP01-21-M01 (update)	IMDEVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		04/05/2022
MHRA-100021-PIP01-21 -M01 (update)	Recombinant SARS-CoV-2 spike (S)-protein virus-like particle	Prevention of coronavirus disease 2019 (COVID-19)		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100024-PIP01-21-M02 (update)	LAROTRECTINIB	Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms	VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100038-PIP01-21-M01 (update)	SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03	Prevention of coronavirus disease 2019 (COVID-19)	Vidprevtyn	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100049-PIP01-21-M02 (update)	IBRUTINIB	Treatment of mature B-cell neoplasm	Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100087-PIP01-21-M01 (update)	LACOSAMIDE	Treatment of generalised epilepsy and epileptic syndromes	VIMPAT lacosamide VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT VIMPAT lacosamide lacosamide	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100099-PIP01-21-M01 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100099-PIP01-21-M02 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo) Briviact Briviact Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100099-PIP01-21-M01 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100108-PIP01-21-M01 (update)	BRIVARACETAM	Treatment of epilepsy with partial onset seizures.	Briviact Briviact Briviact Briviact Briviact BRIVLERA BRIVLERA Briviact Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
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-100137-PIP01-21-M01 (update)	linaclotide	Treatment of functional constipation	Constella	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100167-PIP01-21-M01 (update)	SODIUM ZIRCONIUM CYCLOSILICATE	Treatment of hyperkalaemia	Lokelma Lokelma Lokelma Lokelma	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100205-PIP01-21-M01 (update)	EMPAGLIFLOZIN	Treatment of Type 2 Diabetes Mellitus	Jardiance Jardiance	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100207-PIP01-21-M01 (update)	LINAGLIPTIN	Treatment of Type 2 Diabetes Mellitus	Trajenta Trajenta	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022

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