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NEORAL Oral solution (2017)

Active ingredients: Ciclosporin

Product Name and Form

NEORAL Oral Solution.

Pharmaceutical form

Oral solution.

Clear, faintly yellow to brownish yellow solution.

The formulation of Neoral Oral Solution is a microemulsion preconcentrate.

Qualitative and Quantitative Composition

1 ml oral solution contains 100 mg ciclosporin.

Excipients with known effect:

Ethanol: 94.70 mg/ml. Neoral Oral Solution contains 12% v/v ethanol (9.5% m/v).

Propylene glycol: 94.70 mg/ml.

Macrogolglycerol hydroxystearate/polyoxyl 40 hydrogenated castor oil: 383.70 mg/ml.

For the full list of excipients, see section 6.1.

Chemical substance
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

Alpha–tocopherol
Ethanol anhydrous
Propylene glycol
Corn oil-mono–di–triglycerides
Macrogolglycerol hydroxystearate/polyoxyl 40 hydrogenated castor oil

Pack sizes and Marketing

NEORAL Oral Solution is available in 20 mL and 50 mL amber glass bottles with a rubber stopper and aluminium tear-off cap. The tear-off cap indicates if the bottle has been previously opened. A white polypropylene cap is provided for closure of the bottle during the in-use period.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Novartis Pharmaceuticals UK Ltd

Trading as: Sandoz Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Date of first authorisation: 27 March 1995
Date of latest renewal: 01 July 2003

Marketing authorization number:

PL 0101/0390