Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands
Imlygic 106 plaque forming units (PFU)/mL solution for injection.
Imlygic 108 plaque forming units (PFU)/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Imlygic 106 plaque forming units (PFU)/mL solution for injection: Clear to semi-translucent liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. Imlygic 108 plaque forming units (PFU)/mL solution for injection: Semi-translucent to opaque liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. |
Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1).
Talimogene laherparepvec is produced in Vero cells by recombinant DNA technology.
Imlygic 10 6 plaque forming units (PFU)/mL solution for injection: Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 106 (1 million) plaque forming units (PFU)/mL.
Imlygic 10 8 plaque forming units (PFU)/mL solution for injection: Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 108 (100 million) plaque forming units (PFU)/mL.
Excipient with known effect: Each 4 mL dose contains approximately 30 mg (1.3 mmol) sodium and 80 mg sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Talimogene laherparepvec |
Talimogene laherparepvec is an oncolytic immunotherapy that is derived from HSV-1. Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF. Talimogene laherparepvec causes the death of tumour cells and the release of tumour-derived antigens. |
| List of Excipients |
|---|
|
Di-sodium phosphate dihydrate |
Imlygic is provided as a one ml preservative-free solution in a single–use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene) in two different presentations:
Figure 6. Single-use vial permanently inserted into a clear copolyester plastic sleeve:
OR
Figure 7. Single-use vial without a clear plastic sleeve:
The vial cap is colour coded: 106 (1 million) PFU/mL is light green and 108 (100 million) PFU/mL is royal blue.
Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands
EU/1/15/1064/001
EU/1/15/1064/002
Date of first authorisation: 16 December 2015
| Drug | Countries | |
|---|---|---|
| IMLYGIC | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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