Displaying 21 - 40 of 1112
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102342-PIP01-26
  • Sepiapterin
  • Treatment of hyperphenylalaninaemia
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100709-PIP01-22-M03 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Rystiggo
  • Rystiggo
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101078-PIP01-23-M03 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102526-PIP01-26
  • Egalognastat hydrocloride
  • Treatment of Progressive Supranuclear Palsy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102345-PIP01-26
  • precemtabart tocentecan
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, hematopoietic and lymphoid tissue neoplasms).
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102403-PIP01-26
  • mebufotenin benzoate
  • Treatment of Major Depressive Disorder
  • Neurology
  • Psychiatry
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102479-PIP01-26
  • FLUTICASONE FUROATE
  • UMECLIDINIUM BROMIDE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Trelegy Ellipta
  • Trelegy Ellipta/ Elebrato Ellipta
  • Trelegy Ellipta (PLGB 19494/0287)
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102114-PIP01-25
  • Standardised allergen extract of peanut kernels (Arachis hypogaea)
  • Treatment of peanut allergy
  • Not available at present
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101354-PIP01-24-M01 (update)
  • UPADACITINIB
  • Treatment of alopecia areata
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102377-PIP01-26
  • PIBRENTASVIR
  • GLECAPREVIR
  • Treatment of acute hepatitis C virus (HCV) infection
  • Maviret 100 mg / 40 mg Film-coated tablet
  • Maviret 50 mg / 20 mg Coated granules in sachet
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102369-PIP01-26
  • BHV-8000
  • Treatment of Parkinson’s disease
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101407-PIP01-24-M03 (update)
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Vimkunya
  • Vimkunya
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100559-PIP01-22-M01 (update)
  • MITAPIVAT SULFATE
  • Treatment of thalassaemia
  • PYRUKYND
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100167-PIP01-21-M03 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102404-PIP01-26
  • Gedatolisib
  • Treatment of breast cancer
  • REVTORPYK
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100043-PIP01-21-M02 (update)
  • ZILUCOPLAN SODIUM
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilbrysq
  • Neurology
  • Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100062-PIP01-21-M01 (update)
  • VANZACAFTOR CALCIUM DIHYDRATE
  • TEZACAFTOR
  • DEUTIVACAFTOR
  • Treatment of Cystic Fibrosis
  • alyftrek
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102415-PIP01-26-M01 (update)
  • Nipocalimab
  • Treatment of autoimmune haemolytic anaemia
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Imaavy
  • Neurology
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100351-PIP01-21-M05 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102458-PIP01-26
  • Povetacicept (ALPN-303)
  • Treatment of primary IgA nephropathy
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No