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Displaying 21 - 40 of 1128
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101746-PIP01-24
  • H-(D)p-Benzoylphenylalanyl-(D)seryl-(D)tryptophanyl-(D)seryl-(D)pentafluorophenylalanyl-(D)cyclohexylalanyl-(D)arginyl-(D)arginyl-(D)arginyl-(D)glutaminyl-(D)arginyl-(D)arginine acetate salt
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100440-PIP01-22-M03 (update)
  • EMTRICITABINE
  • BICTEGRAVIR
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Biktarvy
  • Biktarvy
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-100992-PIP01-23-M02 (update)
  • danicopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Voydeya
  • Voydeya
  • Voydeya
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101692-PIP01-24-M01 (update)
  • ATOGEPANT MONOHYDRATE
  • Prevention of migraine headaches
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100807-PIP01-22-M03 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches.
  • Vydura
  • Vydura
  • Nurtec ODT
  • Vydura
  • Vydura
  • Vydura
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101350-PIP01-24
  • DECITABINE
  • Tetrahydrouridine
  • Treatment of sickle cell disease (SCD)
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100330-PIP01-21 -M02 (update)
  • Azamidugene autotemcel (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101336-PIP01-24-M02 (update)
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 3 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 4 SURFACE PROTEINS LIVE ATTENUATED
  • Prevention of dengue fever
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga powder and solvent for solution for injection
  • Qdenga powder and solvent for solution for injection in pre-filled syringe
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100525-PIP01-22-M02 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • ILUMYA
  • ILUMYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100164-PIP01-21-M04 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101619-PIP01-24
  • spesolimab
  • Treatment of hidradenitis suppurativa
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101023-PIP01-23-M03 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101283-PIP01-23-M02 (update)
  • Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
  • Treatment of haemophilia A
  • Treatment of Haemophilia B
  • Fitusiran
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100376-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100635-PIP01-22-M02 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100799-PIP01-22-M02 (update)
  • BEDAQUILINE FUMARATE
  • Treatment of multi-drug resistant tuberculosis.
  • Sirturo
  • Sirturo
  • Sirturo
  • Sirturo
  • Sirturo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100507-PIP01-22-M03 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101723-PIP01-24-M01 (update)
  • USTEKINUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis).
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Selara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100216-PIP01-21-M04 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No