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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
PIP Number MHRA-100779-PIP01-22-M02 (update) Active Substance
  • GUSELKUMAB
 Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
 Invented Name
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
 Therapeutic area
  • Immunology -Rheumatology-Transplantation
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101262-PIP01-23-M01 (update) Active Substance
  • DIENOGEST
  • ETHINYLESTRADIOL
 Conditions / Indications
  • Prevention of pregnancy
 Invented Name
  • Not available at present
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100284-PIP01-21-M02 (update) Active Substance
  • MEXILETINE HYDROCHLORIDE
 Conditions / Indications
  • Treatment of myotonic disorders
 Invented Name
  • Namuscla
  • Namuscla
 Therapeutic area
  • Other: Muscle disorders
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100807-PIP01-22-M02 (update) Active Substance
  • RIMEGEPANT SULFATE
 Conditions / Indications
  • Treatment of migraine headaches
 Invented Name
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
 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
PIP Number MHRA-100695-PIP01-22-M04 (update) Active Substance
  • Etranacogene dezaparvovec
 Conditions / Indications
  • Treatment of haemophilia B
 Invented Name
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
 Therapeutic area
  • Haematology-Hemostaseology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100240-PIP01-21-M04 (update) Active Substance
  • BOSUTINIB
 Conditions / Indications
  • Treatment of chronic myeloid leukemia
 Invented Name
  • Bosulif
  • Bosulif
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Date Published
PIP Number MHRA-101123-PIP01-23-M01 (update) Active Substance
  • BREXUCABTAGENE AUTOLEUCEL
 Conditions / Indications
  • Treatment of acute lymphoblastic leukaemia
 Invented Name
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
 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
PIP Number MHRA-100916-PIP01-23-M01 (update) Active Substance
  • ELUXADOLINE
 Conditions / Indications
  • Treatment of diarrhoea irritable bowel syndrome.
 Invented Name
  • Viberzi
  • Viberzi
  • Viberzi
  • Viberzi
  • Truberzi
 Therapeutic area
  • Gastroenterology-Hepatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101027-PIP01-23-M01 (update) Active Substance
  • ANIFROLUMAB
 Conditions / Indications
  • Treatment of Systemic Lupus Erythematosus
Invented Name
  • Saphnelo
  • Saphnelo
 Therapeutic area
  • Immunology -Rheumatology-Transplantation
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100718-PIP01-22-M02 (update) Active Substance
  • deucravacitinib
 Conditions / Indications
  • Treatment of psoriasis
 Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
 Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100203-PIP01-21-M02 (update) Active Substance
  • Avacopan
 Conditions / Indications
  • Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
 Invented Name
  • Tavneos
 Therapeutic area
  • Immunology -Rheumatology-Transplantation
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100105-PIP01-21-M01 (update) Active Substance
  • ALPRAZOLAM
 Conditions / Indications
  • Treatment of epileptic seizures
 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
PIP Number MHRA-100343-PIP01-21-M03 (update) Active Substance
  • MACITENTAN
 Conditions / Indications
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis.
 Invented Name
  • Opsumit
 Therapeutic area
  • Cardiovascular Diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Date Published
PIP Number MHRA-101234-PIP01-23-M01 (update) Active Substance
  • ALIROCUMAB
 Conditions / Indications
  • Treatment of elevated cholesterol
 Invented Name
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 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
PIP Number MHRA-101293-PIP01-23-M01 (update) Active Substance
  • METHOXYFLURANE
 Conditions / Indications
  • Treatment of acute pain
 Invented Name
  • Penthrox
 Therapeutic area
  • Pain
 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
PIP Number MHRA-101141-PIP01-23-M01 (update) Active Substance
  • mavacamten
 Conditions / Indications
  • Treatment of hypertrophic cardiomyopathy
 Invented Name
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
 Therapeutic area
  • Cardiovascular Diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101078-PIP01-23-M01 (update) Active Substance
  • OLAPARIB
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
 Invented Name
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza 100 mg film-coated tablets
  • Lynparza 150 mg film-coated tablets
 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
PIP Number MHRA-100099-PIP01-21-M04 (update) Active Substance
  • BRIVARACETAM
 Conditions / Indications
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
 Invented Name
  • Briviact (in Italy: Nubriveo)
 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
PIP Number MHRA-100195-PIP01-21-M04 (update) Active Substance
  • BALOXAVIR MARBOXIL
 Conditions / Indications
  • Treatment of Influenza
  • Prevention of Influenza
 Invented Name
  • Xofluxa
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check Yes Compliance outcome Date Published
PIP Number MHRA-101212-PIP01-23-M01 (update) Active Substance
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • enmetazobactam
Conditions / Indications
  • Treatment of infections caused by gram-negative organisms
 Invented Name
  • EXBLIFEP
 Therapeutic area
  • Infectious diseases
 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
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