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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-101230-PIP01-23	teprotumumab	Treatment of thyroid eye disease	Not available at present TEPEZZA	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100974-PIP01-23	BOTULINUM TOXIN TYPE A	Treatment of skin wrinkling	Not yet defined	Other: Aesthetics	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100673-PIP01-22	Fidrisertib	Treatment of fibrodysplasia ossificans progressiva		Other: Musculoskeletal	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100021-PIP01-21	Recombinant SARS-CoV-2 spike (S)-protein virus-like particle	Prevention of coronavirus disease 2019 (COVID-19)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		03/11/2021
MHRA-100064-PIP01-21-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		03/11/2021
MHRA-100038-PIP01-21	Recombinant protein derived from the SARS CoV2 prefusion Spike delta TM protein adjuvanted with AS03	Prevention of Covid-19	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		03/11/2021
MHRA-100072-PIP01-21-M01 (update)	COVID-19 Vaccine (ChAdOx1-S [recombinant])	Prevention of coronavirus disease 2019 (COVID-19)	COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/03/2022
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-100196-PIP01-21	SARS-CoV-2 virus, beta-propiolactone inactivated	Prevention of coronavirus disease 2019 (COVID-19)	Not available	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/05/2022
MHRA-100196-PIP01-21	SARS-CoV-2 virus, beta-propiolactone inactivated	Prevention of coronavirus disease 2019 (COVID-19)	Not available	Vaccines	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-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-100364-PIP01-21	Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01	Prevention of lower respiratory tract disease caused by respiratory syncytial virus	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100237-PIP01-21-M01 (update)	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage) Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Prevention of influenza infection	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe) Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
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-100490-PIP01-22-M01 (update)	nirsevimab (MEDI8897)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).	Beyfortus	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		21/10/2022
MHRA-100470-PIP01-22	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/11/2022

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