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PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-100149-PIP01-21-M01 (update)	NVX-CoV2373	Prevention of coronavirus disease 2019 (COVID-19)	Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted) Nuvaxovid Nuvaxovid Nuvaxovid (Please note that details provided herein specifically relate to Singapore) Nuvaxovid Nuvaxovid (Please note that details provided herein specifically relate to Singapore) Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid Nuvaxovid TBD - Approval not yet granted TBD - Approval not yet granted Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100149-PIP01-21-M02 (update)	NVX-CoV2373	Prevention of coronavirus disease 2019 (COVID-19)	Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted) Nuvaxovid Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
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-100023-PIP01-21-M01 (update)	bimekizumab	Treatment of psoriasis	Bimzelx	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/11/2021
MHRA-100023-PIP01-21-M02 (update)	bimekizumab	Treatment of psoriasis	Bimzelx Bimzelx Bimzelx	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100050-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of immune thrombocytopenia.	Vyvgart Vyvgart	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100025-PIP01-21-M01 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/11/2021
MHRA-100024-PIP01-21-M01 (update)	LAROTRECTINIB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)	VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/12/2021
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-100025-PIP01-21-M02 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100036-PIP01-21-M01 (update)	FERRIC MALTOL	Treatment of Iron deficiency anaemia (IDA)	FERACCRU FERACCRU ACCRUFER FERACCRU	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/11/2021
MHRA-100221-PIP01-21-M01 (update)	BARICITINIB	Treatment of atopic dermatitis	Olumiant Olumiant	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100114-PIP01-21-M01 (update)	BARICITINIB	Treatment of coronavirus disease 2019 (COVID-19)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100443-PIP01-22-M02 (update)	BARICITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100067-PIP01-21-M01 (update)	nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).		Infectious diseases Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/11/2021
MHRA-100160-PIP01-21-M01 (update)	TOCILIZUMAB	Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy	RoActemra RoActemra	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100083-PIP01-21-M01 (update)	Human Fibrinogen (INN) / Human Thrombin (INN) HUMAN THROMBIN HUMAN FIBRINOGEN	Treatment of: haemorrhage from a surgical procedure CSF leakage from a neurosurgical procedure	EVICEL, Solution for sealant EVARREST, Sealant matrix (withdrawn EU MAA) EVICEL EVICEL EVICEL	Other: blood-derived topical haemostats	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	15/11/2021
MHRA-100049-PIP01-21-M01 (update)	IBRUTINIB	Treatment of mature B-cell neoplasm	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.	No	17/11/2021
MHRA-100059-PIP01-21-M01 (update)	roxadustat	Treatment of anaemia due to chronic disorders	EVRENZO EVRENZO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/12/2021

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