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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
MHRA-100249-PIP01-21-M04 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102181-PIP01-25
  • Tinlarebant
  • Treatment of Stargardt disease
  • Ophthamology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102467-PIP01-26-M01 (update)
  • HUMAN FIBRINOGEN
  • Treatment of congenital fibrinogen deficiency
  • Fesilty 1 g Powder and solvent for solution for injection/infusion
  • Fesilty
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101513-PIP01-24-M02 (update)
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
  • Treatment of Type 2 Diabetes Mellitus
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100993-PIP01-23-M03 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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-102514-PIP01-26-M01 (update)
  • Concentrate of proteolytic enzyme enriched in in bromelain
  • Treatment of burns.
  • Nexobrid
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
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
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