Displaying 81 - 100 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100579-PIP01-22-M03 (update)
  • Maribavir
  • Treatment of cytomegalovirus (CMV) infection
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtenicty
  • Livtencity
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100066-PIP01-21-M01 (update)
  • efgartigimod alfa
  • Treatment of myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100443-PIP01-22-M02 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100075-PIP01-21-M02 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Joenja
  • Joenja
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100818-PIP01-22-M01 (update)
  • BEMPEDOIC ACID
  • Treatment of elevated cholesterol
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nexletol® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100907-PIP01-23-M01 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100149-PIP01-21-M02 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100050-PIP01-21-M01 (update)
  • efgartigimod alfa
  • Treatment of immune thrombocytopenia.
  • Vyvgart
  • Vyvgart
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101079-PIP01-23-M01 (update)
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  •  Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100931-PIP01-23-M01 (update)
  • mirikizumab
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100521-PIP01-22-M02 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100897-PIP01-23-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-100758-PIP01-22-M01 (update)
  • BEZLOTOXUMAB
  • Prevention of recurrence of Clostridioides difficile infection
  • ZINPLAVA
  • ZINPLAVA
  • ZINPLAVA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100343-PIP01-21-M02 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101023-PIP01-23-M02 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-101023-PIP01-23-M01 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • ZTALMY
  • ZTALMY
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100195-PIP01-21-M03 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100865-PIP01-23-M01 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100868-PIP01-23-M01 (update)
  • AFAMELANOTIDE
  • Treatment of erythropoietic protoporphyria (EPP)
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100099-PIP01-21-M03 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023