AKIZZA Film coated tablet Ref.[10481] Active ingredients: 17 alpha-Ethinylestradiol Gestodene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Morningside Healthcare Ltd., Unit C, Harcourt Way, Leicester, LE19 1WP, United Kingdom

Product name and form

Akizza 75 mcg / 20 mcg tablets.

Pharmaceutical Form

Film coated tablets.

Round, white to off white, biconvex tablet debossed ‘A’ on one side and other side plain.

Qualitative and quantitative composition

Each film coated tablet contains 75 micrograms gestodene and 20 micrograms ethinylestradiol.

Excipient with known effect: contains 68.97 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
17 alpha-Ethinylestradiol

Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy.

Gestodene
List of Excipients

Tablet core:

Lactose monohydrate
Maize Starch
Povidone 25
Magnesium stearate

Tablet film-coating:

Composition of Opadry white 03F58750
HPMC 2910/Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 6000
Talc (E553b)

Pack sizes and marketing

Tablets are packed in PVC/PVDC/Aluminium blisters inside a sealed tri-laminated pouch.

Pack sizes: 1 × 21 tablets; 3 × 21 tablets, 6 × 21 tablets, 13 × 21 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Morningside Healthcare Ltd., Unit C, Harcourt Way, Leicester, LE19 1WP, United Kingdom

Marketing authorization dates and numbers

PL 20117/0252

24/08/2015

Drugs

Drug Countries
AKIZZA United Kingdom

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