GlaxoSmithKline UK

Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Summary of Product Characteristics last updated on the eMC: 01/02/2012
SPC Zinacef

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 01/02/2012 and displayed until Current
Reasons for adding or updating:
  • 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:   27-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section

Summary of change

6.3

 Shelf life extension from 2 years to 3 years

10.

Updated with new date of revision of text

Updated on 19/11/2008 and displayed until 01/02/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Amendment to add renal impairment and the warning for overgrowth of non-susceptible organisms

Section 4.5 - Information added regarding interaction with oral contraceptives

Section 4.8 - Very rare adverse event of cutaneous vasculitis has been added

Section 10 - Added the date of approval
Updated on 16/05/2006 and displayed until 19/11/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/05/2006 and displayed until 16/05/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   03/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 23/07/2003 and displayed until 12/05/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 11/02/2003 and displayed until 23/07/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 8 - MA number
Updated on 30/05/2002 and displayed until 11/02/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 20/08/2001 and displayed until 30/05/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/05/2002 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/10/2000 and displayed until 22/05/2002
Reasons for adding or updating:
  • No reasons supplied
Updated on 15/05/2000 and displayed until 18/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 15/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   cefuroxime sodium