NOVYNETTE Film-coated tablet Ref.[51230] Active ingredients: 17 alpha-Ethinylestradiol Desogestrel

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: Litha Pharma (Pty) Ltd, 106 16, th Road, Midrand 1685

Product name and form

NOVYNETTE film-coated tablets.

Pharmaceutical Form

White, or almost white (slightly yellow), round shaped, biconvex film-coated tablets of 6 mm diameter, with P9 sign on one side and RG sign on other side.

Qualitative and quantitative composition

NOVYNETTE: Each film-coated tablet contains 0,02 mg ethinylestradiol and 0,15 mg desogestrel.

Contains sugar: Each tablet contains 67.66 mg of 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.

Desogestrel

Desogestrel is a progestogen. Like other progestogen-only pills, desogestrel is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of desogestrel is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

List of Excipients

α-Tocopherol
Ethanol 96%
D&C Yellow no.10
Hypromellose
Magnesium stearate
Macrogol 6000
Potato starch
Povidone K-30
Propylene glycol
Purified water
Silica colloidal anhydrous
Stearic acid

Pack sizes and marketing

Silver, imprinted hard aluminium/PVC/PVDC foil blister containing 21 tablets. Forming foil is hard PVC/PVDC foil and sealing foil is lacquered, printed, hard aluminium foil.

The blister is packed into a carton.

Marketing authorization holder

Litha Pharma (Pty) Ltd, 106 16, th Road, Midrand 1685

Marketing authorization dates and numbers

43/18.8/0071

30 September 2016

Drugs

Drug Countries
NOVYNETTE Estonia, Hong Kong, Croatia, Lithuania, Poland, Romania, South Africa

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