Displaying 1 - 20 of 1090
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-101705-PIP01-24
  • Elamipretide
  • Treatment of Barth syndrome
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101278-PIP01-23
  • oveporexton
  • Treatment of narcolepsy.
  • Treatment of idiopathic hypersomnia.
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100820-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100087-PIP01-21-M03 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • VIMPAT
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100069-PIP01-21-M01 (update)
  • RIBOCICLIB SUCCINATE
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100075-PIP01-21-M03 (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
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101678-PIP01-24
  • Mirdametinib
  • Treatment of neurofibromatosis type 1
  • Not available at present
  • Gomeklio
  • Gomeklio
  • Neurology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102497-PIP01-26
  • PONATINIB
  • PONATINIB HYDROCHLORIDE
  • Treatment of chronic myeloid leukaemia (CML)
  • Treatment of acute lymphoblastic leukaemia
  • Ponatinib Incyte
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101661-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of atopic dermatitis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted