Erbitux 5mg/mLsolution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mLof solution for infusion contains 5mg cetuximab Each vial of 20mLcontains 100mg cetuximab Each vial of 100mLcontains 500mg cetuximab Cetuximab is a chimeric monoclonal IgG1antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology
Cetuximab nu prezintă utilizare relevantă la copii și adolescenți în indicațiile aprobate Mod de administrare Erbitux 5mg/ml se administrează intravenos, cu ajutorul unei pompe de perfuzie, al unui picurător gravitațional sau al unui injectomat (pentru instrucțiuni privind manipularea, vezi pct 6 6 )
Erbitux® (cetuximab) May 2017 Merck Oncology PROGNOSIS The active substance in Erbitux, cetuximab, is a monoclonal antibody A monoclonal antibody is a type of protein that has been designed to recognize and attach to a specific structure (called an antigen) in the body Erbitux has been designed to attach to the EGFR, which can be found on
Erbitux 5mg/ml διάλυμα για έγχυση 2 ΠΟΙΟΤΙΚΗΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ Κάθε ml του διαλύματος για έγχυση περιέχει 5mg cetuximab Κάθε φιαλίδιο των 20ml περιέχει 100mg cetuximab Κάθε φιαλίδιο των 100ml περιέχει 500mg cetuximab
Erbitux 5 mg/ml oldatos infúzió 2 MINŐSÉGI ÉS MENNYISÉGIÖSSZETÉTEL 5 mg cetuximab 1 ml oldatos infúzióban Egy darab 20 ml-es injekciós üveg 100mg cetuximabot tartalmaz Egy darab 100 ml-es injekciós üveg 500mg cetuximabot tartalmaz A cetuximab emlős sejtvonalban (Sp2/0) rekombináns DNS-technológiával előállított, IgG1
Erbitux 5 mg/ml Infusionslösung - Merck Group
Die Verabreichung von Erbitux kann entweder als Tropfinfusion, mit einer Infusionspumpe oder einem Perfusor erfolgen Da Erbitux nur mit steriler 0,9 iger Kochsalzlösung (9 mg Natriumchlorid/ml) für Injektionszwecke kompatibel ist, darf die Infusionslösung nicht mit anderen intravenös verabreichten Arzneimitteln gemischt werden
An agency of the European Union ENCePP Plenary meeting 12 November Introduction to Pharmacogenomics Presented by: Marisa Papaluca Head of Scientific Support Office
the biosimilar story: the next chapter of biologics y horsmans, md, phd be-1510-bios-076 001
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European Medicines Agency
Qu’est-ce qu’Erbitux? Erbitux est une solution pour perfusion (goutte-à-goutte dans une veine), qui contient le principe actif cetuximab Erbitux est autorisé depuis juin 2004 Il est déjà utilisé pour le traitement des types de cancer suivants: • cancer métastatique du colon ou du rectum (gros intestin) «Métastatique» signifie
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Erbitux - European Medicines Agency
Erbitux should only be given under the supervision of a doctor who has experience in the use of anticancer medicines in a setting where facilities for resuscitation are available Before receiving Erbitux, the patient must be given an antihistamine and a corticosteroid to prevent an allergic reaction
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Merck To Present New Data at the European Cancer Congress
New Erbitux subanalysis data from multiple studies in colorectal and head and neck cancers will also be featured Darmstadt, Germany, September 11, 2015 – Merck will present new dataon early- and late-stage compounds from its refocused oncology and immunooncology pipeline- , as well as Erbitux ® (cetuximab) data, at this year’s European Cancer Congress (ECC) , held in Vienna, Austria
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Your Contact News Release Phone +49 6151 72 3890
Erbitux ® (cetuximab) in the *Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C) †In September 2014, Merck discontinued all company-sponsored clinical trials with tecemotide in non-small cell lung cancer worldwide Notes to Editors Accepted abstracts submitted by Merck related to our oncology and immuno-oncology pipeline
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ENCePP Plenary meeting 12 November
An agency of the European Union ENCePP Plenary meeting 12 November Introduction to Pharmacogenomics Presented by: Marisa Papaluca Head of Scientific Support Office
[PDF]
Their regulatory status and their use - VZA
by INN + brand name + manufacturer + batch number (+ country of origin) NB Some complain that the SmPC of the biosimilar is identical to that of the originator (except a simple mention in 5 1: « X is a biosimilar – detailed information available on website of EMA » )
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CURRENT STATUS AND FUTURE OUTLOOK FOR BIOSIMILARS
INN, International non-proprietary name 11 Monoclonal Antibodies: Key Therapies for Several Diseases • Cancers • Hematologic diseases • Autoimmune diseases 4 The Number of Therapeutic Monoclonal Antibodies Is Constantly Increasing Number of therapeutic antibodies entering clinical study per year Reichert J, et al Nat Biotechnol 2005;23(9):1073-1078 0 Murine Chimeric
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Kun je biosimilars maken van originele
INN* Referentiegeneesmiddel Aflopen marktexclusiviteit in EU Biosimilar verwacht (jaar) Adalimumab Humira Oktober 2018 2018 Rituximab Mabthera November 2013 2017 Etanercept Enbrel Februari 2015 2016 Bevacizumab Avastin Januari 2022 2022 Trastuzumab Herceptin Juli 2014 2017 Pegfilgrastim Neulasta Augustus 2017 2017 Cetuximab Erbitux Juni 2014 2018
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THE BIOSIMILAR STORY: THE NEXT CHAPTER OF BIOLOGICS Y
the biosimilar story: the next chapter of biologics y horsmans, md, phd be-1510-bios-076 001
Chez les patients atteints de cancer colorectal métastatique, le cetuximab est utilisé en association avec la chimiothérapie ou en monothérapie (voir rubrique
erbitux epar product information fr
cetuximab The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS metastatic colorectal cancer
erbitux epar product information en
Erbitux contains cetuximab, a monoclonal antibody Cetuximab binds to the Detailed information on this medicine is available on the European Medicines
Erbitux Leaflet
En pacientes con cáncer colorrectal metastásico, cetuximab se utiliza en monoterapia o en La combinación de Erbitux y quimioterapia basada en oxaliplatino está contraindicada en Europea de Medicamentos http://www ema europa eu/
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Cada ml de solución para perfusión contiene 5 mg de cetuximab Erbitux está indicado para el tratamiento de pacientes con cáncer colorrectal La Agencia Europea de Medicamentos ha eximido al titular de la obligación de presentar los
ERBITUX FT
European Medicines Agency, 2009 Reproduction is authorised provided the source is acknowledged Ref doc : EMEA/266938/2009 EMEA/H/C/558 Erbitux
FT ERBITUX
Chez les patients atteints de cancer colorectal métastatique le cetuximab est utilisé en association avec la chimiothérapie ou en monothérapie (voir
Detailed information on this medicinal product is available on the website of the European Medicines. Agency http://www.ema.europa.eu/. Page 21. 21. ANNEX II. A
E-mail: mail@emea.europa.eu http://www.emea.europa.eu Erbitux cetuximab. Le 23 juillet 2009 le comité des médicaments à usage humain (CHMP) a adopté un ...
Chaque ml de solution pour perfusion contient 2 mg de cetuximab. Erbitux en association avec l'irinotecan est indiqué dans le traitement des patients ...
Chez les patients atteints de cancer colorectal métastatique le cetuximab est utilisé en association avec la chimiothérapie ou en monothérapie (voir
In patients failing irinotecan-based regimens oxaliplatin-based regimens are used in Europe. Despite the progress obtained to date
21 nov. 2013 Pursuant to Article 16 of Commission Regulation (EC) No 1234/2008 Merck KGaA submitted to the. European Medicines Agency on 22 October 2012 an ...
Erbitux cetuximab. This is a summary of the European public assessment report Erbitux is used to treat metastatic cancer of the colon or rectum (large ...
E-mail: mail@emea.europa.eu http://www.emea.europa.eu ERBITUX. International non-proprietary name/Common name: cetuximab. Procedure No. EMEA/H/C/558/II/ ...
28 mai 2008 Erbitux in combination with irinotecan is indicated for the treatment of ... compared FOLFIRI and FOLFOX with or without cetuximab in ...
Erbitux INN-cetuximab