PREMARIN Coated tablet Ref.[8089] Active ingredients: Estrogens, conjugated

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Premarin 0.625 mg Coated Tablets.

Pharmaceutical Form

Coated Tablet.

Maroon oval biconvex sugar-coated tablet marked with “0.625” in white ink.

Qualitative and quantitative composition

Each tablet contains 0.625 mg conjugated estrogens.

Excipients with known effect: Each tablet contains lactose monohydrate 54.1 mg and sucrose 45 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Estrogens, conjugated

The active ingredients of conjugated estrogens are primarily the sulfate esters of estrone, equilin sulfates, 17α-estradiol and 17β-estradiol. These substitute for the loss of estrogen production in menopausal women, and alleviate menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy.

List of Excipients

Compressed Tablet Cores:

Lactose Monohydrate (Spray Dried)
Microcrystalline Cellulose
Hypromellose 2208, K100M (100,000cps)
Magnesium Stearate

Tablet Coating:

Filler Coat:

Sucrose
Microcrystalline Cellulose
Hydroxypropyl Cellulose
Hypromellose, 2910, E6 (6cps)
Hypromellose, 2910, E15 (15cps)
Polyethylene Glycol 400

Colour Coat:

Opadry Maroon 03B16083#

Polishing:

Hypromellose, 2910, E6 (6cps)
Carnauba Wax

Brand:

Opacode WB NS-78-18011, White Ink##

# The colorant Opadry Maroon 03B16083 contains: HPMC 2910/Hypromellose, 6cP, Titanium Dioxide, FD&C Red #40 Aluminium Lake (E129), PEG 400/Macrogol and FD&C Blue #2 Aluminium Lake (E132).
## The white branding ink Opacode WB NS-78-18011 contains: Titanium Dioxide, Propylene Glycol and Hypromellose 2910, 3cP.

Pack sizes and marketing

Blister pack consisting of a PVC/Aclar/PVC and a hard tempered aluminium foil lid containing 28 tablets.

One carton pack contains 3 blisters.

Securitainers containing 100 tablets. PVC/Aluminium foil blisters containing 21 tablets.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1285

21 July 2011

Drugs

Drug Countries
PREMARIN Brazil, Canada, Hong Kong, Ireland, Japan, Malta, Mexico, New Zealand, Singapore, United Kingdom, United States

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