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PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-100254-PIP01-21	epcoritamab	Treatment of mature B-cell malignancies	Not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100254-PIP01-21-M01 (update)	epcoritamab	Treatment of mature B-cell malignancies	Not available at present	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100230-PIP01-21	Thienopyrimidine Derivative	Treatment of fibrosing interstitial lung disease		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100208-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of non-alcoholic steatohepatitis		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100209-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of obesity		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100275-PIP01-21	SEMAGLUTIDE	Treatment of non-alcoholic steatohepatitis (NASH)	Ozempic OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Ozempic Ozempic Ozempic Ozempic OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100467-PIP01-22-M01 (update)	SEMAGLUTIDE	Treatment of obesity	Ozempic Ozempic 0.25 mg, 0.5 mg, 1 mg	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100287-PIP01-21	SEMAGLUTIDE	Treatment of obesity	Not available at present Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100368-PIP01-21	aumolertinib	Treatment of lung cancer	Ameile	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100381-PIP01-21	Regdanvimab	Treatment of coronavirus disease 2019 (COVID-19)	Regkirona Regkirona Inj.	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100324-PIP01-21	Loncastuximab tesirine	Treatment of mature B-cell neoplasms	Zynlonta Zynlonta	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	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-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-100087-PIP01-21-M02 (update)	LACOSAMIDE	Treatment of generalised epilepsy and epileptic syndromes.		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
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-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-100137-PIP01-21-M02 (update)	linaclotide	Treatment of functional constipation	Constella Constella Constella Constella Constella	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023

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