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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-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
MHRA-100679-PIP01-22-M01 (update)
  • Talazoparib
  • Treatment of Ewing Sarcoma
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101849-PIP01-25
  • lemborexant
  • Treatment of chronic insomnia
  • Not available at present
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Dayvigo
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102312-PIP01-26
  • EYE103/MK-3000
  • Treatment of age-related macular degeneration.
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101008-PIP01-23-M02 (update)
  • AMBRISENTAN
  • Treatment of pulmonary arterial hypertension.
  • Volibris
  • Volibris
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102388-PIP01-26
  • Rinzimetostat
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102425-PIP01-26
  • PF-08634404
  • Treatment of all conditions included in the category of malignant neoplasms (except melanoma, central nervous system, haematopoietic and lymphoid tissue)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102499-PIP01-26
  • etalanetug
  • Treatment of Alzheimer's disease
  • Not Yet Available
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101021-PIP01-23-M04 (update)
  • FILGOTINIB MALEATE
  • Chronic idiopathic arthritis
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No