AROMASIN Coated tablets Ref.[8195] Active ingredients: Exemestane

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Product name and form

Aromasin 25 mg coated tablets.

Pharmaceutical Form

Coated tablet.

Round, biconvex, off-white coated tablet marked 7663 on one side.

Qualitative and quantitative composition

Active substance: exemestane.

Each coated tablet contains 25 mg exemestane.

Excipients with known effect: Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl parahydroxybenzoate (E218).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Exemestane

Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione.
List of Excipients

Tablet core:

Silica colloidal hydrated
Crospovidone
Hypromellose
Magnesium stearate
Mannitol
Microcrystalline cellulose
Sodium starch glycolate (Type A)
Polysorbate

Sugar-coating:

Hypromellose
Polyvinylalcohol
Simeticone
Macrogol
Sucrose
Magnesium carbonate, light
Titanium dioxide(E171)
Methyl parahydroxybenzoate (E218)
Cetyl esters wax
Talc
Carnauba wax

Printing ink:

Ethyl alcohol
Shellac
Iron oxides (E172)
Titanium oxide (E171)

Pack sizes and marketing

15, 20, 30, 90, 100 and 120 tablets in blister packs (Aluminium-PVDC/PVC-PVDC)

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/0930

16th December 1998 / 8th August 2008

Drugs

Drug Countries
AROMASIN Austria, Australia, Brazil, Canada, Germany, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
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