5.3 Preclinical safety data

 Preclinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction, genotoxicity or carcinogenicity, beyond the information included in other sections of the SPC. Due to the lack of pharmacokinetic data in humans, margins of exposure between humans and animals can not be established.

Immune complex deposition in the glomeruli of the kidney was reported in a small number of rats and monkeys treated for at least 6 months. In a 2 years rat study, no indication of immune complex deposition in the glomeruli of the kidney was seen.

Anaphylaxis after administration to sensitised animals (guinea pigs or mice) was reported. The relevance of these data for humans is unknown.

Toxicity at the injection site was a common finding after repeated administration in animals.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Mannitol

Water for Injections

6.2 Incompatibilities

 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

 2 years

6.4 Special precautions for storage

 Keep the container in the outer carton, in order to protect from light.

Store in refrigerator (2°C to 8°C).

Do not freeze.

If the pre-filled syringes cannot be stored in a refrigerator, they can be stored at room temperature (15°C to 25°C), once for up to one month.

After this one month period, if the Copaxone 20 mg/ml pre-filled syringes have not been used and are still in their original packaging, they must be returned to storage in a refrigerator (2°C to 8°C).

6.5 Nature and contents of container

 Copaxone solution for injection is contained in a pre-filled syringe, consisting of a Type I colourless glass barrel, a plastic plunger and a rubber stopper.

Packs containing 7 and 28 pre-filled syringes will be supplied.

Not all pack sizes may be marketed.

The volume of solution in the syringe is 1.0 ml.

6.6 Special precautions for disposal and other handling

 For single use only. Any unused product or waste material must be discarded.

7. MARKETING AUTHORISATION HOLDER

 Teva Pharmaceuticals Ltd.

5 Chancery Lane,

Clifford's Inn,

London EC4A 1BU,

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

 PA1014/1/2.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorization: 7 April 2003

10. DATE OF REVISION OF THE TEXT

 February 2009.