Displaying 41 - 60 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
PIP Number MHRA-101244-PIP01-23 Active Substance
  • UPADACITINIB
Conditions / Indications
  • Treatment of vitiligo
Invented Name
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100999-PIP03-23 Active Substance
  • Ensitrelvir
Conditions / Indications
  • Prevention of coronavirus disease 2019 (COVID-19).
Invented Name
  • Zokovea
  • Xocova
Therapeutic area
  • Infectious diseases
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101248-PIP01-23 Active Substance
  • UPADACITINIB
Conditions / Indications
  • Treatment of systemic lupus erythematosus
Invented Name
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100999-PIP02-23 Active Substance
  • Ensitrelvir
Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
Invented Name
  • Zokovea
  • Xocova
Therapeutic area
  • Infectious diseases
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101091-PIP01-23 Active Substance
  • Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine (VLA15 - PF-07307405)
Conditions / Indications
  • Prevention of Lyme disease
Invented Name Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101049-PIP01-23 Active Substance
  • retifanlimab
Conditions / Indications
  • Treatment of Merkel cell carcinoma
Invented Name
  • ZYNYZ
  • retifanlimab
Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100996-PIP01-23 Active Substance
  • GIPR antagonist/GLP-1R agonist- AMG 133
Conditions / Indications
  • Treatment of obesity
Invented Name
  • Not available at present
Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100790-PIP01-22-M01 (update) Active Substance
  • Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
Conditions / Indications
  • Treatment of Duchenne muscular dystrophy
Invented Name Therapeutic area
  • Neurology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101647-PIP01-24-M01 (update) Active Substance
  • IXEKIZUMAB
Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
Invented Name
  • Taltz
  • Taltz
  • Taltz
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Date Published Sort ascending
PIP Number MHRA-100348-PIP01-21-M02 (update) Active Substance
  • botaretigene sparoparvovec
Conditions / Indications
  • Treatment of retinitis pigmentosa
Invented Name Therapeutic area
  • Ophthamology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101618-PIP01-24-M01 (update) Active Substance
  • ADRENALINE
Conditions / Indications
  • Treatment of allergic reactions
Invented Name
  • neffy
  • NEFFY
  • EURneffy
Therapeutic area
  • Pneumology - Allergology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Partial Compliance Check Granted Date Published Sort ascending
PIP Number MHRA-100479-PIP01-22-M03 (update) Active Substance
  • POSACONAZOLE
Conditions / Indications
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
Invented Name
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
Therapeutic area
  • Infectious diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100252-PIP01-21-M02 (update) Active Substance
  • GEMTUZUMAB OZOGAMICIN
Conditions / Indications
  • Treatment of acute myeloid leukaemia
Invented Name
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
Therapeutic area
  • Oncology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101596-PIP01-24-M01 (update) Active Substance
  • Ibrexafungerp
Conditions / Indications
  • Treatment of vulvovaginal candidiasis
  • Prevention of recurrent vulvovaginal candidiasis
Invented Name Therapeutic area
  • Infectious diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Full Compliance Check Granted Date Published Sort ascending
PIP Number MHRA-101588-PIP01-24 Active Substance
  • Derivative of 1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one
Conditions / Indications
  • Treatment of lung cancer
Invented Name Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100084-PIP01-21-M03 (update) Active Substance
  • MIDOSTAURIN
Conditions / Indications
  • Treatment of acute myeloid leukaemia
  • Treatment of malignant mastocytosis
  • Treatment of mast cell leukaemia
Invented Name
  • Rydapt
  • Rydapt
Therapeutic area
  • Oncology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101587-PIP01-24-M01 (update) Active Substance
  • CEFIDEROCOL SULFATE TOSYLATE
Conditions / Indications
  • Treatment of infections due to aerobic Gram-negative bacteria
Invented Name
  • Fetcroja
  • Fetcroja
  • Fetroja
  • Fetcroja
  • Fetroja
Therapeutic area
  • Infectious diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101586-PIP01-24 Active Substance
  • Ifinatamab deruxtecan
Conditions / Indications
  • Treatment of lung cancer (small cell and non-small cell lung cancer)
Invented Name Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101583-PIP01-24-M01 (update) Active Substance
  • Recombinant Varicella Zoster Virus Glycoprotein E
Conditions / Indications
  • Prevention of varicella zoster virus (VZV) reactivation
Invented Name
  • Shingrix
  • Shingrix
  • Shingrix
  • Shingrix
Therapeutic area
  • Vaccines
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100920-PIP01-23-M01 (update) Active Substance
  • 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
Conditions / Indications
  • Prevention of disease caused by Streptococcus pneumoniae.
Invented Name
  • TBD
  • CAPVAXIVE®
  • CAPVAXIVEâ„¢
Therapeutic area
  • Vaccines
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Partial Compliance Check Granted Date Published Sort ascending