Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Nplate 125 micrograms powder for solution for injection.
Nplate 250 micrograms powder for solution for injection.
Nplate 500 micrograms powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). The powder is white. |
Nplate 125 micrograms powder for solution for injection: Each vial contains 125 mcg of romiplostim. After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered.
Nplate 250 micrograms powder for solution for injection: Each vial contains 250 mcg of romiplostim. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered.
Nplate 500 micrograms powder for solution for injection: Each vial contains 500 mcg of romiplostim. After reconstitution, a deliverable volume of 1 mL solution contains 500 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered.
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Romiplostim |
Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Single-dose vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene). The 125 mcg vial cap is beige, the 250 mcg vial cap is red and the 500 mcg vial cap is blue.
Carton containing 1 or 4 vials of romiplostim.
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/08/497/009
EU/1/08/497/010
EU/1/08/497/001
EU/1/08/497/003
EU/1/08/497/002
EU/1/08/497/004
Date of first authorisation: 4 February 2009
Date of latest renewal: 20 December 2013
| Drug | Countries | |
|---|---|---|
| NPLATE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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