Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Synagis 50 mg/0.5 ml solution for injection.
Synagis 100 mg/1 ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is clear or slightly opalescent. |
1 ml of Synagis solution contains 100 mg of palivizumab*.
Each 0.5 ml vial contains 50 mg of palivizumab.
Each 1 ml vial contains 100 mg of palivizumab.
* Palivizumab is a recombinant humanised monoclonal antibody produced by DNA technology in mouse myeloma host cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Palivizumab |
Palivizumab is a humanised IgG1Îș monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. |
| List of Excipients |
|---|
|
Histidine |
Single-use vials: 3 ml capacity, clear, colourless type I glass vial with a chlorobutyl stopper and flipoff seal containing either 0.5 ml or 1 ml of solution for injection.
Pack size of 1.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
EU/1/99/117/003
EU/1/99/117/004
Date of first authorisation: 13 August 1999
Date of latest renewal: 27 July 2009
| Drug | Countries | |
|---|---|---|
| SYNAGIS | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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