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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 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-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-100216-PIP01-21-M06 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis.
  • Adtralza
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100249-PIP01-21-M05 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100294-PIP01-21-M02 (update)
  • BENRALIZUMAB
  • Treatment of asthma
  • FASENRA
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102456-PIP01-26
  • Saruparib
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100406-PIP01-21-M04 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled pen
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101953-PIP01-25-M03 (update)
  • Nipocalimab
  • Treatment of myasthenia gravis
  • Imaavy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102391-PIP01-26
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • APRETUDE
  • Apretude 600 mg prolonged-release suspension for injection (PLGB 35728/0062)
  • Apretude 30 mg film-coated tablets (PLGB 35728/0061)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101185-PIP01-23-M01 (update)
  • gefurulimab
  • Treatment of myasthenia gravis
  • KLYGEFA
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102433-PIP01-26
  • MK-8748/EYE201
  • Treatment of age-related macular degeneration.
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100721-PIP01-22-M01 (update)
  • Tividenofusp alfa
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102310-PIP01-26
  • surabgene lomparvovec
  • Treatment of diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100648-PIP01-22-M02 (update)
  • TECOVIRIMAT MONOHYDRATE
  • Treatment of orthopoxvirus disease (smallpox, mpox, cowpox, and vaccinia)
  • Tecovirimat SIGA
  • Tecovirimat SIGA
  • TPOXX
  • TPOXX
  • TEPOXX
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No