DEXIMUNE Capsule, soft Ref.[27632] Active ingredients: Ciclosporin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: DEXCEL-PHARMA LTD, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry, Northamptonshire, NN11 8PB, United Kingdom

Product name and form

Deximune 25 mg soft capsules.

Pharmaceutical Form

Capsule, soft.

Deximune 25 mg soft capsules are gray soft gelatin capsules with imprinting ‘DX 25 mg’.

Qualitative and quantitative composition

Each soft capsule contains 25 mg Ciclosporin.

For full list of excipients, see Section 6.1.

Active Ingredient Description
Ciclosporin

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

List of Excipients

Polysorbate 20
Sorbitan oleate
Lecithin from Soya
Triglyceride
Macrogolglycerol hydroxystearate
Ethyl lactate

Ingredients of the capsule shell:

Gelatin
Glycerol
Ferric oxide black (E172)
Titanium dioxide (E171)

Pack sizes and marketing

The capsules are available in blister packs of double-sided aluminium consisting of an aluminium bottom foil and an aluminium covering foil, which are contained within a printed cardboard carton.

Deximune Capsules are available in 30, 50 or 60 capsules in each carton.

Not all pack sizes may be marketed.

Marketing authorization holder

DEXCEL-PHARMA LTD, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry, Northamptonshire, NN11 8PB, United Kingdom

Marketing authorization dates and numbers

PL 14017/0215

27 January 2010

Drugs

Drug Countries
DEXIMUNE Germany, Ireland, Israel, Malta, Singapore, United Kingdom

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