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ACITRETIN Capsule, hard (2016)

Product Name and Form

Acitretin 10 mg Capsules.

Pharmaceutical form

Capsule, hard.

Acitretin 10 mg consists of a white to off-white body and a brown cap, printed in black with “A10” on the capsule body and filled with a yellow powder.

Qualitative and Quantitative Composition

Each capsule, hard of Acitretin 10 mg contains 10 mg acitretin.

For the full list of excipients, see section 6.1

List of excipients

Capsule filling:

Maltodextrin
Sodium ascorbate
Microcrystalline cellulose

Capsule shell:

Gelatin
Propylene glycol
Sodium laurilsulfate
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide black (E172)
Iron oxide red (E172)
Shellac

Pack sizes and Marketing

PVC/PVDC aluminium blister packs

Pack sizes: 30 and 60 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

31/10/2015

Marketing authorization number:

PL 06831/0251