COPAXONE Solution for injection Ref.[8738] Active ingredients: Glatiramer

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Teva Pharmaceuticals Ltd., Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX United Kingdom

Product name and form

Copaxone 20 mg/ml solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection

Clear solution free of visible particles.

The solution for injection has a pH of 5.5 – 7.0 and an osmolarity of about 265 mOsmol/L.

Qualitative and quantitative composition

1 pre-filled syringe (1 ml) of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer.

* Glatiramer acetate is the acetate salt of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine, in molar fraction ranges of 0.129-0.153, 0.392-0.462, 0.086-0.100 and 0.300-0.374, respectively. The average molecular weight of glatiramer acetate is in the range of 5,000-9,000 daltons. Due to its compositional complexity, no specific polypeptide can be fully characterised, including in terms of amino acid sequence, although the final glatiramer acetate composition is not entirely random.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Glatiramer is presumed to involve modulation of immune processes. Glatiramer is licensed for reduced frequency of relapses in relapsing-remitting multiple sclerosis.

List of Excipients

Water for injections

Pack sizes and marketing

A pre-filled syringe containing Copaxone solution for injection consists of a 1 ml colourless type I glass syringe barrel with staked needle, a polypropylene (optional polystyrene) plunger rod, a rubber plunger stopper and a needle shield.

Each pre-filled syringe is packed separately in a PVC blister pack.

Copaxone is available in packs containing 7, 28 or 30 pre-filled syringes of 1 ml solution for injection or a multipack containing 90 (3 packs of 30) pre-filled syringes of 1 ml solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Ltd., Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX United Kingdom

Marketing authorization dates and numbers

PL 10921/0023

Date of first authorisation: 7 April 2003
Date of latest renewal: 11 September 2007


Drug Countries
COPAXONE Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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