TAMOXIFEN Tablet Ref.[7488] Active ingredients: Tamoxifen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Product name and form

Tamoxifen 20 mg Tablets.

Pharmaceutical Form

Tablet.

The tablets are white, round, biconvex tablets marked TN|20 on one side and G on reverse with an approximate diameter of 9.5 mm.

Qualitative and quantitative composition

Each tablet contains 30.4 mg tamoxifen citrate equivalent to tamoxifen 20 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tamoxifen

Tamoxifen is a non-steroidal, triphenylethylene-based drug which displays a complex spectrum of oestrogen antagonist and oestrogen agonist-like pharmacological effects in different tissues.

List of Excipients

Mannitol
Maize starch
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

Polypropylene tablet container with white polyethylene caps and polyethylene ullage filler; and PVC/Aluminium Blister Pack; and High density polyethylene (HDPE) containers with polyethylene snap closures in packs of 5, 7, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0070

Date of first authorisation: 31/08/1989
Date of last renewal: 24/01/2006

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