TAMIFEN Tablet Ref.[28261] Active ingredients: Tamoxifen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Tamifen 10mg tablets.

Tamifen DS 20mg tablets.

Pharmaceutical Form

Tablet.

For oral administration.

Tamifen 10mg tablets: White, round, flat, scored tablets, with a diameter of 7.0 mm.

Tamifen DS 20mg tablets: White, round, flat, scored tablets, with a diameter of 8.0 mm.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each tablet contains 10mg or 20mg of tamoxifen as tamoxifen citrate E.P.

Excipient with known effect: lactose.

Each Tamifen 10mg tablet contains 93.6mg of lactose monohydrate.

Each Tamifen DS 20mg tablet contains 80.2mg lactose monohydrate.

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

Tamifen 10mg tablet: microcrystalline cellulose, lactose, croscarmellose sodium, silicon dioxide and magnesium stearate.

Tamifen DS 20mg tablet: microcrystalline cellulose, lactose, sodium carboxymethylcellulose, talc and magnesium stearate.

Pack sizes and marketing

Tamifen 10mg: PVC/PVDC-Al blisters of 10 tablets are available. Packs of 30 and 100 tablets are available.

Tamifen DS 20mg: PVC-Al blisters of 10 tablets are available. Packs of 30 and 100 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Tamifen 10 mg tablets: 8520
Tamifen DS 20 mg tablets: 10918

Tamifen 10 mg tablets: 11-10-1982
Tamifen DS 20 mg tablets: 22-11-1986

Drugs

Drug Countries
TAMIFEN Cyprus, Hong Kong, Tunisia

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.