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Displaying 21 - 40 of 669
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100829-PIP01-22
  • Edaravone
  • Treatment of Amyotrophic lateral sclerosis
  • Not available at this moment
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100114-PIP01-21
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100265-PIP01-21
  • BARICITINIB
  • Treatment of alopecia areata
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100221-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of atopic dermatitis
  • Olumiant
  • Olumiant
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100114-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100443-PIP01-22-M02 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100067-PIP01-21-M01 (update)
  • nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100120-PIP01-21
  • TOCILIZUMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • RoActemra
  • RoActemra
  • Infectious diseases
  • Other: Covid-19 pandemic
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100160-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
  • RoActemra
  • RoActemra
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100028-PIP01-21
  • tixagevimab (AZD8895)
  • cilgavimab (AZD1061)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment of Coronavirus Disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100038-PIP01-21
  • Recombinant protein derived from the SARS CoV2 prefusion Spike delta TM protein adjuvanted with AS03
  • Prevention of Covid-19
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100046-PIP01-21-M02 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100046-PIP01-21-M04 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Xcopri
  • Ontozry
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100083-PIP01-21-M01 (update)
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
  • Other: blood-derived topical haemostats
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/11/2021
MHRA-100174-PIP01-21
  • Encequidar
  • Treatment of breast cancer
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100049-PIP01-21-M01 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/11/2021
MHRA-100070-PIP01-21
  • molnupiravir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/11/2021
MHRA-100346-PIP01-21
  • molnupiravir
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Lagevrio
  • Lagevrio
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100053-PIP01-21
  • REGN10987
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not Yet Available
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/11/2021
MHRA-100052-PIP01-21
  • REGN10933
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not Yet Available
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/11/2021