Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
MYLOTARG 5 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white cake or powder. |
Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin.
After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gemtuzumab ozogamicin |
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody that is directed against the antigen CD33, an adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage. The anticancer effect of gemtuzumab ozogamycin is due to the commitment of ADC to cancer cells expressing CD33, with ultimate result the induction of DNA fragment and subsequent cell cycle interruption and finally the apoptotic cell death. |
| List of Excipients |
|---|
|
Dextran 40 |
Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Each carton contains 1 vial.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
EU/1/18/1277/001
Date of first authorisation: 19 April 2018
| Drug | Countries | |
|---|---|---|
| MYLOTARG | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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