NOVOFEN Tablet Ref.[28217] Active ingredients: Tamoxifen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus, EU

Product name and form

Novofen 10 mg tablets.

Pharmaceutical Form

Tablet.

White, round, flat, scored tablets.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains tamoxifen citrate equivalent to 10 mg tamoxifen.

Excipient(s) with known effect:

This product contains 101,5 mg lactose.

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

Povidone
Lactose monohydrate
Cellulose, microcrystalline
Maize starch
Sodium starch glycolate (Type A)
Magnesium stearate
Talc
Silica, colloidal anhydrous

Pack sizes and marketing

Aluminium strips. Pack sizes of 30 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus, EU

Marketing authorization dates and numbers

9123

Date of first authorization: 21 October 1983
Date of latest renewal: 28 August 2013

Drugs

Drug Countries
NOVOFEN Cyprus, Singapore

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