Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Partner Therapeutics Ltd., 28 - 32 Pembroke Street Upper, Dublin 2, Ireland., D02NT28, Tel: +353.1264.1754, e-mail: info@partnertx.com
Imreplys 250 microgram powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). Lyophilised, white to off-white powder. |
Each vial contains 250 mcg sargramostim*.
After reconstitution each mL contains 250 mcg sargramostim.
* Sargramostim is a human granulocyte-macrophage colony-stimulating growth factor (GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Sargramostim is a recombinant human GM-CSF. The binding to GM-CSF receptors expressed on the surface of target cells (haematopoietic progenitors and mature immune cells), initiates an intracellular signalling cascade which induces the cellular responses (i.e., division, maturation, activation). GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, it can promote the proliferation and maturation of megakaryocytic and erythroid progenitors. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Pack size of five 8 mL (Type I clear glass) vials.
Partner Therapeutics Ltd., 28 - 32 Pembroke Street Upper, Dublin 2, Ireland., D02NT28, Tel: +353.1264.1754, e-mail: info@partnertx.com
EU/1/25/1924/001
| Drug | Countries | |
|---|---|---|
| IMREPLYS | Austria, Estonia, Italy, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.