Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria
Zessly 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). The powder is a freeze-dried white pellet. |
Each vial contains 100 mg of infliximab. Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. After reconstitution each ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Infliximab |
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ). |
| List of Excipients |
|---|
|
Disodium succinate hexahydrate |
Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap.
Zessly is available in packs containing 1, 2, 3, 4 or 5 vials.
Not all pack sizes may be marketed.
Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria
EU/1/18/1280/001
EU/1/18/1280/002
EU/1/18/1280/003
EU/1/18/1280/004
EU/1/18/1280/005
Date of first authorisation: 18 May 2018
| Drug | Countries | |
|---|---|---|
| ZESSLY | Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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