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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
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-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-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-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-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-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-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-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-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-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-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-100346-PIP01-21	molnupiravir	Prevention of coronavirus disease 2019 (COVID-19)	Lagevrio Lagevrio	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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-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-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-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-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-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

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