Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Polivy 30 mg powder for concentrate for solution for infusion.
Polivy 140 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to greyish-white lyophilized cake. |
Polivy 30 mg powder for concentrate for solution for infusion: Each vial of powder for concentrate for solution for infusion contains 30 mg of polatuzumab vedotin. After reconstitution, each mL contains 20 mg of polatuzumab vedotin.
Polivy 140 mg powder for concentrate for solution for infusion: Each vial of powder for concentrate for solution for infusion contains 140 mg of polatuzumab vedotin. After reconstitution, each mL contains 20 mg of polatuzumab vedotin.
Polatuzumab vedotin is an antibody-drug conjugate composed of the anti-mitotic agent monomethyl auristatin E (MMAE) covalently conjugated to a CD79b-directed monoclonal antibody (recombinant humanized immunoglobulin G1 [IgG1], produced in Chinese Hamster Ovary cells by recombinant DNA technology).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Polatuzumab vedotin |
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis. |
| List of Excipients |
|---|
|
Succinic acid |
Polivy 30 mg powder for concentrate for solution for infusion: 6 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminium seal with plastic flip-off cap containing 30 mg polatuzumab vedotin. Pack size of one vial.
Polivy 140 mg powder for concentrate for solution for infusion: 20 mL vial (colourless Type 1 glass) closed with a stopper (fluororesin laminate), with an aluminium seal with plastic flip-off cap containing 140 mg polatuzumab vedotin. Pack size of one vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/19/1388/001
EU/1/19/1388/002
Date of first authorisation: 16 January 2020
Date of latest renewal: 03 December 2021
| Drug | Countries | |
|---|---|---|
| POLIVY | Austria, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
