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Displaying 1 - 20 of 147
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101995-PIP01-25-M01 (update)
  • ISOFLURANE
  • Sedation of mechanically ventilated patients
  • Sedaconda and associated names
  • Other: Sedation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101758-PIP01-24
  • deuruxolitinib
  • Treatment of alopecia areata
  • LEQSELVI
  • LEQSELVI
  • Other: immunosuppressant
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-101897-PIP01-25
  • doxecitine
  • doxribtimine
  • Treatment of thymidine kinase 2 deficiency
  • KYGEVVI
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100214-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uraemic syndrome (aHUS)
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100213-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100237-PIP01-21-M02 (update)
  • 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)
  • 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
  • Prevention of influenza infection
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (QIV-HD)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101748-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains: A/(H1N1)-Like Virus Antigen A/(H3N2)-Like Virus Antigen B/-Like Virus Antigen
  • Prevention of influenza
  • Cell-based Trivalent Influenza Vaccine Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX
  • FLUCELVAX
  • FLUCELVAX
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101678-PIP01-24
  • Mirdametinib
  • Treatment of neurofibromatosis type 1
  • Not available at present
  • Gomeklio
  • Gomeklio
  • Neurology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100475-PIP01-22-M02 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101773-PIP01-24-M01 (update)
  • Tabelecleucel
  • Treatment of Epstein-Barr virus associated post-transplant lymphoproliferative disorder.
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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
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
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
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
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
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
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
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
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®
  • CAPVAXIVEâ„¢
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted