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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-100303-PIP01-21-M03 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • COBICISTAT
  • DARUNAVIR ETHANOLATE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Symtuza
  • Symtuza
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 10/03/2025
MHRA-101725-PIP01-24
  • GUSELKUMAB
  • Treatment of psoriasis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 10/03/2025
MHRA-101711-PIP01-24-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Other: Complement-driven renal disease
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-100239-PIP01-21-M02 (update)
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-100811-PIP01-22-M03 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • AGAMREE
  • Agmaree
  • AGAMREE
  • Other: Neuromuscular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 11/02/2025
MHRA-101647-PIP01-24-M01 (update)
  • IXEKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
  • Taltz
  • Taltz
  • Taltz
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 06/01/2025
MHRA-101618-PIP01-24-M01 (update)
  • ADRENALINE
  • Treatment of allergic reactions
  • neffy
  • NEFFY
  • EURneffy
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/01/2025
MHRA-101596-PIP01-24-M01 (update)
  • Ibrexafungerp
  • Treatment of vulvovaginal candidiasis
  • Prevention of recurrent vulvovaginal candidiasis
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 06/01/2025
MHRA-100920-PIP01-23-M01 (update)
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae.
  • TBD
  • CAPVAXIVE®
  • CAPVAXIVE™
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/01/2025
MHRA-100392-PIP01-21-M05 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • TOZINAMERAN/FAMTOZINAMERAN
  • TOZINAMERAN/RILTOZINAMERAN
  • RAXTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial, COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/11/2024
MHRA-100284-PIP01-21-M03 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Namuscla
  • Namuscla
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-100670-PIP01-22-M01 (update)
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Brexafemme
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-100502-PIP01-22-M03 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza disease
  • Supemtek
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-101495-PIP01-24
  • 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 B-like strain
  • Prevention of influenza disease
  • not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 28/10/2024
MHRA-101407-PIP01-24
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 28/10/2024
MHRA-100139-PIP01-21
  • Teplizumab
  • Prevention or delay of (clinical) type 1 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 09/10/2024
MHRA-101335-PIP01-24-M01 (update)
  • LANDIOLOL HYDROCHLORIDE
  • Treatment of supraventricular arrhythmias.
  • Rapibloc
  • Rapibloc
  • Rapibloc
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 03/10/2024
MHRA-101492-PIP01-24
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (RIV3)
  • Prevention of influenza disease
  • Flublok
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 03/10/2024
MHRA-101389-PIP01-24
  • omaveloxolone
  • Treatment of Friedreich's ataxia
  • Skyclarys
  • Skyclarys
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 15/08/2024
MHRA-100343-PIP01-21-M04 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 15/08/2024