PROGYLUTON Coated tablets Ref.[50731] Active ingredients: Estradiol Norgestrel

Source: Marketing Authorisation Holder  Revision Year: 2023  Publisher: Bayer Israel LTD, 36 Hacharash st., Hod Hasharon 4527702 Manufacturer: Bayer Weimar GMBH UND CO.KG, Dobereinerstrasse 20, Weimar 99427, Germany

Product name and form

Progyluton.

Pharmaceutical Form

Coated tablets.

Qualitative and quantitative composition

Active substances:

Calendar-pack containing 11 white tablets of 2 mg estradiol valerate each, plus 10 light brown tablets of 2 mg estradiol valerate and 0.5 mg norgestrel each.

Excipients:

Each white coated tablet contains 46.220 mg lactose monohydrate.

Each light brown coated tablets contain 45.720mg lactose monohydrate.

Active Ingredient Description
Estradiol

Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy.

Norgestrel
List of Excipients

Lactose monohydrate, maize starch, polyvidone 25000, talc, magnesium stearate, sucrose, polyvidone 700000, macrogol 6000, calcium carbonate, glycerol 85%, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172), montanglycol wax

Pack sizes and marketing

Calendar pack containing 1 × 21 coated tablets (B).

Marketing authorization holder

Bayer Israel LTD, 36 Hacharash st., Hod Hasharon 4527702

Manufacturer: Bayer Weimar GMBH UND CO.KG, Dobereinerstrasse 20, Weimar 99427, Germany

Marketing authorization dates and numbers

032-90-22502-00

Drugs

Drug Countries
PROGYLUTON Ecuador, Spain, Israel, Mexico, Singapore

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