ROVULUM Film-coated tablet Ref.[51187] Active ingredients: Dienogest

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

ROVULUM 2 mg film coated tablets.

Pharmaceutical Form

Film-coated tablets.

ROVULUM is a white, round, biconvex film-coated tablet embossed with “2” on one side.

Qualitative and quantitative composition

Each film-coated tablet of ROVULUM contains 2 mg of dienogest.

Contains sugar: Lactose monohydrate 57,2 mg.

For full list of excipients, see section 6.1.

Active Ingredient Description
Dienogest

Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest binds to the progesterone receptor of the human uterus with only 10% of the relative affinity of progesterone.

List of Excipients

Cottonseed oil hydrogenated
Hydroxypropylcellulose (E463)
Hypromellose (E464)
Lactose monohydrate
Maize starch
Magnesium stearate
Povidone
Sodium starch glycolate (type A)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

ROVULUM is packed in PVC/PVDC/Aluminium blister strips. The blister strips are packed in printed cartons. Pack size of 28 film-coated tablets.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

52/21.8.2/0336

14 June 2022

Drugs

Drug Countries
ROVULUM South Africa

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