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DANOL 100mg Capsule, hard (2019)

Product Name and Form

Danol 100mg Capsules.

Pharmaceutical form

Capsule, hard.

Capsule with a grey cap and opaque white body containing a white or almost white powder, with ‘D100’ printed in black ink.

Qualitative and Quantitative Composition

Each capsule contains 100mg of danazol.

Also contains 62 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

List of excipients

Capsule:

Maize starch
Lactose monohydrate
Purified talc
Magnesium stearate

Cap:

Titanium dioxide (E171)
Gelatin
Black iron oxide

Capsule Shell Body (size 3):

Titanium dioxide (E171)
Gelatin

Black Ink:

Shellac Glaze 45% (20% esterified) in ethanol
Iron oxide black (E172)
Propylene glycol (E1520)
Ammonium hydroxide 28%

Or

Shellac
Propylene glycol
Strong ammonia solution
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and Marketing

PVC blister pack compound of polyvinyl chloride (thickness 250µm) sealed to aluminium foil (thickness 20µm). The blisters are then packed in a cardboard carton.

Pack sizes: 50, 60 and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Date of First Authorisation: 10 June 1974
Date of Latest Renewal: 2 April 2002

Marketing authorization number:

PL 04425/0194