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Displaying 101 - 120 of 692

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort descending
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-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
MHRA-100213-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of Paroxysmal Nocturnal Haemoglobinuria	Ultomiris Ultomiris Ultomiris Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100214-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of atypical Haemolytic Uremic Syndrome	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100216-PIP01-21-M01 (update)	TRALOKINUMAB	Treatment of atopic dermatitis	Adtralza Adtralaza Adtralza	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100217-PIP01-21-M01 (update)	ERIBULIN	Treatment of soft tissue sarcoma	Halaven Halaven	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100229-PIP01-21-M01 (update)	NINTEDANIB	Treatment of fibrosing Interstitial Lung Diseases (ILD)	Ofev Vargatef Ofev Vargatef	Pneumology - Allergology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022

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