Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Lartruvo 10 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles. |
One mL of concentrate for solution for infusion contains 10 mg of olaratumab.
Each 19 mL vial contains 190 mg of olaratumab.
Each 50 mL vial contains 500 mg of olaratumab.
Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Excipient with known effect:
Each 19mL vial contains approximately 22 mg (1 mmol) sodium.
Each 50 mL vial contains approximately 57 mg (2.5 mmol) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Olaratumab |
Olaratumab is an antagonist of platelet derived growth factor receptor-α (PDGFR-α), expressed on tumour and stromal cells. Olaratumab is a targeted, recombinant, fully human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFR-α, blocking PDGF AA, -BB, and |
| List of Excipients |
|---|
|
Mannitol (E421) |
19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap.
Pack of 1 vial of 19 mL.
Pack of 2 vials of 19 mL.
Pack of 1 vial of 50 mL.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/16/1143/001-003
Date of first authorisation: 9 November 2016
Date of latest renewal: 21 September 2017
| Drug | Countries | |
|---|---|---|
| LARTRUVO | Brazil, Estonia, Ireland, Lithuania, Poland, United States |
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