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Displaying 161 - 180 of 478
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100636-PIP01-22-M01 (update)
  • Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
  • Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100406-PIP01-21-M01 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100406-PIP01-21-M02 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100471-PIP01-22-M01 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • Nutrition
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M01 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M02 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M03 (update)
  • Maribavir
  • Treatment of cytomegalovirus (CMV) infection
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtenicty
  • Livtencity
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100695-PIP01-22-M01 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100695-PIP01-22-M02 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100695-PIP01-22-M04 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100418-PIP01-22-M01 (update)
  • axicabtagene ciloleucel
  • Treatment of mature B-cell neoplasms
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100297-PIP01-21
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100600-PIP01-22-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease
  • Imvanex
  • Imvamune
  • Jynneos
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100608-PIP01-22-M01 (update)
  • mitapivat
  • Treatment of pyruvate kinase deficiency
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100601-PIP01-22-M01 (update)
  • elasomeran
  • imelasomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax bivalent Original / Omicron
  • Spikevax
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100601-PIP01-22-M02 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100601-PIP01-22-M03 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • ANDUSOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB1.5
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100564-PIP01-22-M01 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100564-PIP01-22-M02 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024