MODIGRAF Granules for oral suspension Ref.[27677] Active ingredients: Tacrolimus

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

Product name and form

Modigraf 0.2 mg granules for oral suspension.

Modigraf 1 mg granules for oral suspension.

Pharmaceutical Form

Granules for oral suspension.

White granules.

Qualitative and quantitative composition

Modigraf 0.2 mg granules for oral suspension

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).

Modigraf 1 mg granules for oral suspension

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
Hypromellose (E464)
Croscarmellose sodium (E468)

Pack sizes and marketing

Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).

Pack size: carton box containing 50 sachets.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
MODIGRAF Austria, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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