NOLVADEX D Film-coated tablet Ref.[51030] Active ingredients: Tamoxifen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: AstraZeneca AB, SE-151 85 Sodertalje, Sweden

Product name and form

Nolvadex D 20 mg Film-coated Tablets.

Pharmaceutical Form

Film coated tablet.

Octaganol, white, film-coated tablet marked ‘Nolvadex’ D on one face and plain on the reverse.

Qualitative and quantitative composition

Tablets containing 20 mg tamoxifen present as Tamoxifen Citrate.

Excipient with known effect: each tablet contains 234mg 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

Croscarmellose sodium
Gelatin
Lactose monohydrate
Macrogol 300
Magnesium stearate
Maize starch
Hypromellose
Titanium dioxide

Pack sizes and marketing

Aluminium blister pack (30).

Marketing authorization holder

AstraZeneca AB, SE-151 85 Sodertalje, Sweden

Marketing authorization dates and numbers

PA1019/014/001

Date of first authorisation: 10 May 1983
Date of last renewal: 10 May 2008

Drugs

Drug Countries
NOLVADEX Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Italy, Japan, Malta, Mexico, Poland, Singapore, South Africa
 
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