ANARGIL Capsule, hard Ref.[28101] Active ingredients: Danazol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Anargil 100mg capsules, hard.

Anargil 200mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

Anargil 100mg capsules hard: yellow capsules.

Anargil 200mg capsules hard: orange capsules.

For oral administration.

Qualitative and quantitative composition

Each capsule contains 100mg or 200mg danazol.

Excipient with known effect: lactose.

Each 100mg capsule contains 123mg of lactose.

Each 200mg capsule contains 35mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Danazol

Danazol is a synthetic steroid derived from ethisterone an is indicated for the treatment of endometriosis and benign fibrocystic breast disease.

List of Excipients

Anargil capsules contain maize starch, povidone, lactose, croscarmellose sodium, sodium lauryl sulphate and magnesium stearate.

Anargil 100mg capsules' shell contain gelatin, quinolone yellow (E104), iron oxide yellow (E172) and titanium dioxide (E171).

Anargil 200mg capsules' shell contain gelatin, Erythrosin (E127), quinolone yellow (E104) and titanium dioxide (E171).

Pack sizes and marketing

Combination polyvinylchloride-aluminium blisters of ten capsules. Five or ten such blisters (50 capsules or 100 capsules) are contained in a card carton. Also, PVC securitainers with 50,100 and 500 capsules are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Anargil 100mg capsules, hard: 19832
Anargil 200mg capsules, hard: 19833

Anargil 100mg capsules, hard: 16.12.2005/07.05.2014
Anargil 200mg capsules, hard: 16.12.2005/07.05.2014

Drugs

Drug Countries
ANARGIL Cyprus, Hong Kong

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