Preferred Label : ofatumumab;

Obsolete resource : false;

MeSH note : an anti-CD20 MAb used as an antineoplastic agent; in phase 1-2 clinical trials;

CISMeF synonym : arzerra; immunoglobulin G1, anti-(human CD20 (antigen))(human monoclonal humax-CD20 heavy chain), disulfide with human monoclonal humax-CD20 kappa-chain, dimer;

MeSH hyponym : HUMAX-CD20-2F2; HUMAX-CD20, 2F2; GSK-1841157;

Is substance : O;

UNII : M95KG522R0;

Details


Main resources

You can consult :


https://www.has-sante.fr/jcms/p_3410976/fr/kesimpta-ofatumumab-sclerose-en-plaques
2023
false
false
false
France
withdrawing treatment
Medication set-up education, guidance, and counseling (procedure)
ofatumumab
injections, subcutaneous
evaluation of the transparency committee
ofatumumab
multiple sclerosis, relapsing-remitting

---
https://www.has-sante.fr/jcms/p_3270638/fr/kesimpta-ofatumumab
2021
false
false
false
France
French
evaluation of the transparency committee
ofatumumab
antibodies, monoclonal, humanized
treatment outcome
insurance, health, reimbursement
adult
multiple sclerosis, relapsing-remitting
ofatumumab
injections, subcutaneous
Product containing only ofatumumab in parenteral dose form (medicinal product form)
antigens, CD20

---
https://www.ema.europa.eu/en/medicines/human/EPAR/kesimpta
2021
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
europe
drug approval
ofatumumab
ofatumumab
ofatumumab
adult
multiple sclerosis, relapsing-remitting
injections, subcutaneous
Anti-CD20 Monoclonal Antibody
antibodies, monoclonal, humanized
antibodies, monoclonal, humanized
antigens, CD20
product surveillance, postmarketing
drug interactions
pregnancy
breast feeding
aged
drug evaluation, preclinical
antibodies, monoclonal
antibodies, monoclonal

---
https://www.has-sante.fr/portail/jcms/c_2857791/fr/arzerra
2018
false
false
false
false
France
French
evaluation of the transparency committee
treatment outcome
insurance, health, reimbursement
arzerra
ofatumumab
antibodies, monoclonal

---
http://www.has-sante.fr/portail/jcms/c_2748409/fr/arzerra
2017
false
false
false
France
French
evaluation of the transparency committee
antineoplastic combined chemotherapy protocols
ofatumumab
ofatumumab
cyclophosphamide
fludarabine
antibodies, monoclonal
vidarabine

---
http://www.has-sante.fr/portail/jcms/c_2040126/fr/arzerra
http://www.has-sante.fr/portail/jcms/c_2040126/fr/arzerra-ofatumumab-anticorps-monoclonal
2015
false
France
French
guidelines for drug use
infusions, intravenous
ofatumumab
antibodies, monoclonal
orphan drug production
antigens, CD20
ofatumumab
leukemia, lymphocytic, chronic, B-Cell
ofatumumab
antibodies, monoclonal
treatment outcome
evaluation of the transparency committee

---
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40851a-fra.php
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40853a-fra.php
2014
false
false
false
Canada
French
English
pharmacovigilance note
ofatumumab
ofatumumab
leukemia, lymphocytic, chronic, B-Cell
infusions, intravenous
antigens, CD20
death, sudden
Infusion-Related Reaction
antibodies, monoclonal

---
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37705a-fra.php
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37707a-fra.php
2014
Canada
French
English
ofatumumab
ofatumumab
hepatitis b virus
Reactivation of hepatitis B viral hepatitis (disorder)
virus activation
antigens, CD20
leukemia, lymphocytic, chronic, B-Cell
mass screening
hepatitis b virus
continuity of patient care
ofatumumab
pharmacovigilance note
patient education handout
guidelines for drug use
hepatitis B
antibodies, monoclonal
antibodies, monoclonal
Contraindications, Procedure
Contraindications, Drug

---
https://hpr-rps.hres.ca/reg-content/sommaire-motif-decision-detailOne.php?lang=fr&linkID=SBD00273
2012
false
Canada
French
English
ofatumumab
ofatumumab
ofatumumab
antigens, CD20
antineoplastic agents
antineoplastic agents
drug approval
canada
leukemia, lymphocytic, chronic, B-Cell
drug evaluation, preclinical
treatment outcome
survival analysis
clinical trials, phase ii as topic
risk assessment
summary of product characteristics
antibodies, monoclonal
antibodies, monoclonal

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67423712
2012
France
summary of product characteristics
package leaflet
ofatumumab

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64598731
2012
France
summary of product characteristics
package leaflet
ofatumumab

---
http://www.cochrane.org/fr/CD008079
2012
false
France
United Kingdom
French
french abstract
meta-analysis
leukemia, lymphocytic, chronic, B-Cell
treatment outcome
antigens, CD20
ofatumumab
antineoplastic agents
antibodies, monoclonal
Rituximab

---
https://www.ema.europa.eu/medicines/human/EPAR/Arzerra
2012
United Kingdom
French
English
syndication feed
antibodies, monoclonal
antibodies, monoclonal
drug approval
drug labeling
treatment outcome
infusions, intravenous
antigens, CD20
survival analysis
drug evaluation, preclinical
antineoplastic agents
antineoplastic agents
ofatumumab
ofatumumab
ofatumumab
adult
aged
pregnancy
breast feeding
leukemia, lymphocytic, chronic, B-Cell
orphan drug production
antibodies, monoclonal
summary of product characteristics
package leaflet
drug evaluation

---
http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-10/arzerra_-_ct-8366.pdf
http://www.has-sante.fr/portail/jcms/c_1019621/arzerra-ofatumumab-anticorps-monoclonal
2010
France
French
ofatumumab
antibodies, monoclonal
ofatumumab
leukemia, lymphoid
chronic disease
infusions, intravenous
antigens, CD20
treatment outcome
survival analysis
ofatumumab
antibodies, monoclonal
orphan drug production
antibodies, monoclonal
guidelines for drug use
evaluation of the transparency committee

---
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13/05/2024


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