Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Neovii Biotech GmbH, Am Haag 6+7, 82166 Graefelfing, Germany
Grafalon 20 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear to slightly opalescent and colourless to pale yellow solution, pH = 3.4-4.0 |
20 mg anti-human T-lymphocyte immunoglobulin from rabbits per 1 ml Grafalon (100mg/5ml vial or 200mg/10ml vial).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Antithymocyte immunoglobulin |
Antithymocyte immunoglobulin is a selective immunosuppressive agent mostly acting on T lymphocytes. Antithymocyte immunoglobulin is used for the prevention and treatment of graft rejection after solid organ transplantation, usually in combination with other immunosuppressive drugs. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
Pack with 1 or 10 vials containing 5 ml solution.
Pack with 1 or 10 vials containing 10 ml solution.
Neovii Biotech GmbH, Am Haag 6+7, 82166 Graefelfing, Germany
PA1015/001/001
Date of first authorisation: 05 June 2001
Date of last renewal: 05 June 2006
| Drug | Countries | |
|---|---|---|
| GRAFALON | Austria, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey |
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