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Displaying 301 - 320 of 325
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100048-PIP01-21
  • Afamitresgene autoleucel
  • Treatment of soft tissue sarcoma
  • Not available at present.
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100043-PIP01-21
  • zilucoplan
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilqivik
  • Neurology
  • Other: Neurodegenerative disorder, auto-immune disease/dysfunction
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100044-PIP01-21
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100080-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of Immune Thrombocytopenic Purpura
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100142-PIP01-21
  • Synthetic Hypericin
  • Treatment of cutaneous T-cell lymphoma
  • HyBryte
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100131-PIP01-21
  • ATEZOLIZUMAB
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100111-PIP01-21
  • DORAVIRINE
  • Islatravir
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection.
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/12/2021
MHRA-100081-PIP01-21
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Other: Renal Disease
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100074-PIP01-21
  • GABAPENTIN
  • Treatment of Postherpetic Neuralgia
  • Gralise
  • Neurology
  • Pain
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100152-PIP01-21
  • cosibelimab
  • Treatment of cutaneous squamous cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/12/2021
MHRA-100029-PIP01-21
  • COVID-19 vaccine (Ad26.COV2-S (recombinant))
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2021
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
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-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-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-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-100173-PIP01-21
  • PACLITAXEL
  • 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-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-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-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