Displaying 1 - 20 of 692
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100149-PIP01-21
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid (proposed invented name)
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 21/10/2021
MHRA-100149-PIP01-21-M01 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • TBD - Approval not yet granted
  • TBD - Approval not yet granted
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100149-PIP01-21-M02 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 03/11/2021
MHRA-100021-PIP01-21 -M01 (update)
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100023-PIP01-21-M01 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100022-PIP01-21
  • bimekizumab
  • Hidradenitis suppurativa
  • Immunology -Rheumatology-Transplantation
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/11/2021
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100066-PIP01-21
  • efgartigimod alfa
  • Treatment of myastenia gravis (MG)
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100155-PIP01-21
  • efgartigimod alfa
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
MHRA-100050-PIP01-21
  • efgartigimod alfa
  • Treatment of Immune thrombocytopenia
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100199-PIP01-21
  • efgartigimod alfa
  • Treatment of Pemphigus
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100743-PIP01-22-M01 (update)
  • efgartigimod alfa
  • Treatment of generalised myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 02/02/2023
MHRA-100513-PIP01-22
  • efgartigimod alfa
  • Treatment of dermatomyositis
  • Treatment of immune-mediated necrotizing myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100917-PIP01-23
  • efgartigimod alfa
  • Treatment of Bullous Pemphigoid
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100050-PIP01-21-M01 (update)
  • efgartigimod alfa
  • Treatment of immune thrombocytopenia.
  • Vyvgart
  • Vyvgart
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100025-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100024-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100024-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100025-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023