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Eisai Ltd
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN
Telephone: +44 (0)845 676 1400
Fax: +44 (0)845 676 1486
WWW: http://www.eisai.co.uk
Medical Information e-mail: Lmedinfo@eisai.net
Out of Hours Telephone: +44 (0)845 676 1400

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 28/11/2011
SPC Zebinix 800mg tablets

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 28/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   10-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Addition of three additional uncommon undesirable effects to section 4.8 – irritability, chest pain, urinary tract infection, Change to section 10 – change to date of revision of text
Updated on 10/01/2011 and displayed until 28/11/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 has some minor cahnges to wording but no change to meaning
Section 4.5 - Interactions have been added between eslicarbazepine actate and carbamazepine and eslicarbazepine acetate and simvastatin
Section 4.6 - Fertility information has been added to this section (and has been removed from section 5.3)
Section 6.3 - shelf life has been increased from 2 to 3 years
Section 10 - date of revision of text has been udpates
Updated on 23/10/2009 and displayed until 10/01/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  eslicarbazepine acetate