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Teva Pharmaceuticals Ltd
The Gate House, Gatehouse Way, Aylesbury, Bucks, HP19 8DB, UK
Telephone: +44 (0)1296 719 768
Fax: +44 (0)1296 719 769
Medical Information e-mail: Med.info@tevapharma.co.uk

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Summary of Product Characteristics last updated on the eMC: 17/04/2009
SPC Copaxone 20mg/ml, Solution For Injection, Pre-Filled Syringe

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/04/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 : New indication added.

Copaxone is indicated for the treatment of patients who have experienced a well-defined first clinical episode and are determined to be at high risk of developing clinical definite multiple sclerosis (CDMS) (see Section 5.1)

Section 4.8 : Amendments to 'Undesirable Effects' section.

The safety data collected from the PreCISe study has been added to that obtained in the 3 RRMS pivotal trials.  This has led to changes in the tolerability profile presented.

 

Section 4.9 : Update to wording in ‘Overdose Symptoms, Emergency Procedures, Antidotes’ section

 

In clinical trials, daily doses of up to 30 mg glatiramer acetate for up to 24 months were not associated with adverse reactions other than those mentioned in Section 4.8.

 

Section 5.1 : Addition to 'Pharmacodynamic Properties' section

 

Addition of data concerning single clinical event suggestive of MS.

 

Section 6.4 :   Addition to ‘Special Precautions for Storage’ section

 

Do not freeze.

 
Updated on 30/10/2008 and displayed until 17/04/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   15-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 : Indication reworded.

Copaxone is indicated for the reduction in frequency of relapses in ambulatory patients (i.e. who can walk unaided) with relapsing-remitting multiple sclerosis (MS). In clinical trials this was characterised by at least two attacks of neurological dysfunction over the preceding two-year period (see Section 5.1).

Section 4.2 : Amendment to 'Paediatric Use' section.

Children and adolescents: No prospective, randomised, controlled clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving Copaxone 20 mg subcutaneously every day is similar to that seen in adults. There is not enough information available on the use of Copaxone in children below 12 years of age to make any recommendation for its use. Therefore, Copaxone should not be used in this population.

Section 4.6 : Minor rewording in pregnancy section.

Section 4.8 : Information in table of undesirable effects converted to MedDRA terms.

Section 5.1 : Update to exposure data.

Exposure data are available for up to twelve years in 103 patients treated with Copaxone.
Updated on 10/09/2007 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4
Storage at room temperature (15°C to 25°C) extended from 7 days to one month.
Updated on 23/03/2006 and displayed until 10/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  glatiramer acetate