Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands
Modigraf 0.2 mg granules for oral suspension.
Modigraf 1 mg granules for oral suspension.
| Pharmaceutical Form |
|---|
|
Granules for oral suspension. White granules. |
Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 94.7 mg lactose (as monohydrate).
Each sachet contains less than 1 mmol sodium (23 mg).
Each sachet contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 473 mg lactose (as monohydrate).
Each sachet contains less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tacrolimus |
Tacrolimus is a highly potent immunosuppressive agent. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor. |
| List of Excipients |
|---|
|
Lactose monohydrate |
Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).
Pack size: carton box containing 50 sachets.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands
Modigraf 0.2 mg granules for oral suspension: EU/1/09/523/001
Modigraf 1 mg granules for oral suspension: EU/1/09/523/002
Date of first authorisation: 15 May 2009
Date of latest renewal: 17 Feb 2014
| Drug | Countries | |
|---|---|---|
| MODIGRAF | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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