ADOPORT Capsule, hard Ref.[27892] Active ingredients: Tacrolimus

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Product name and form

Adoport 0.5 mg Capsules, hard.

Pharmaceutical Form

Capsule, hard.

Opaque white and ivory hard gelatin capsule containing white to off- white powder. (length: 14.5 mm).

Qualitative and quantitative composition

Each hard capsule contains 0.5 mg of tacrolimus (as tacrolimus monohydrate).

Excipient with known effect:

Each hard capsule contains 46.1 mg lactose (as monohydrate).

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

Capsule contents:

Hypromellose (E464)
Lactose monohydrate
Croscarmellose Sodium (E468)
Magnesium stearate (E572)

Hard gelatine capsule:

Gelatin
Titanium dioxide (E171)
Sodium laurilsulfate
Sorbitan laureate
Yellow iron oxide (E172)

Pack sizes and marketing

PVC/PE/PVdC/Aluminium blisters with desiccant in Aluminium bag.

Packs of 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Marketing authorization dates and numbers

PL 04416/0939

31/05/2014

Drugs

Drug Countries
ADOPORT Spain, France, Italy, Turkey, United Kingdom

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