Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 21 - 40 of 295
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-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-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-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-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-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-100109-PIP01-21
  • Islatravir
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
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-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-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-100185-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of cold agglutinin disease
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100556-PIP01-22
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
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-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-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-100056-PIP01-21
  • BENRALIZUMAB
  • Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100057-PIP01-21
  • BENRALIZUMAB
  • Treatment of eosinophilic oesophagitis
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100140-PIP01-21
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100184-PIP01-21
  • BENRALIZUMAB
  • Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100141-PIP01-21
  • BENRALIZUMAB
  • Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022