CEPTAVA Gastro-resistant tablet Ref.[27641] Active ingredients: Mycophenolic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Product name and form

Ceptava 180 mg Gastro-resistant Tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Lime green film-coated round tablets with bevelled edges and the imprint (debossing) ‘C’ on one side.

Dimensions: approximately 10.4 × 4.2 mm.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 180 mg of mycophenolic acid (as mycophenolate sodium).

Excipients with known effect:

Each gastro-resistant tablet contains 12.93 mg of sodium (as mycophenolate sodium) and 45 mg of lactose (anhydrous).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mycophenolic acid

Mycophenolic acid is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Mycophenolic acid has more potent cytostatic effects on lymphocytes than on other cells and is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

List of Excipients

Core:

Lactose, anhydrous
Crospovidone (Type A)
Povidone K30
Maize starch/Corn starch
Silica, colloidal anhydrous/Colloidal silicon dioxide
Magnesium stearate

Coating:

Hypromellose phthalate HP 50
Titanium dioxide (E171)
Iron oxide yellow (E172)/Ferric oxide
Indigotine (Indigo carmine) (F, D & C Blue No. 2, E132)

Pack sizes and marketing

PA/AL/PVC-aluminium blister packs.

Pack sizes:

20, 50, 100, 120, 250 gastro-resistant tablets.

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 04416/1467

Date of first authorisation: 15 December 2016

Drugs

Drug Countries
CEPTAVA Spain, Italy, United Kingdom

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