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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 09/11/2011
SPC Zyvox 600 mg Film-Coated Tablets, 100 mg/5 ml Granules for Oral Suspension, 2 mg/ml Solution for Infusion

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 09/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   09-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Update to section 9
Updated on 05/10/2011 and displayed until 09/11/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   07-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.5 has been amended
Updated on 23/06/2011 and displayed until 05/10/2011
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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   20-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Updated sections 4.4, 4.5, 4.7 & 4.8
Updated on 29/09/2010 and displayed until 23/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   16-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC Toxic Epidermal Necrolysis added as an adverse event to section 4.8
Updated on 14/10/2009 and displayed until 29/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   28-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of Alopecia and reordering of Section 4.8

Alopecia has been added as an Adverse Event – also post marketing adverse events have been added to AE Frequency Table (as reported post marketing actual frequency cannot be estimated from the available data – so assigned – “Not Known”)
Updated on 30/06/2009 and displayed until 14/10/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   24-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Paediatric Wording - To update sections 4.2 (Posology and method of administration), 4.8 (Undesirable effects), 5.1 (Pharmacodynamic properties) and 5.2 (Pharmacokinetic properties) of the SPC and consequentially the leaflet following the assessment of the paediatric data submitted as part of the European Paediatric Worksharing project.

To update sections 4.4 (Special warnings and precautions for use) and 4.5 (Interaction with other medicinal products and other forms of interaction) of the SPC and consequentially the PIL by adding some warnings according to the company core data sheet.

To update section 4.8 (Undesirable effects) of the SPC and consequentially the leaflet by adding Pseudomembranous colitis and tooth discoloration as undesirable effects according to the company core data sheet.
Updated on 23/07/2007 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 
Section 5.1 Update of information on breakpoints, susceptibility and resistance.
Updated on 05/07/2007 and displayed until 23/07/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/04/2007 and displayed until 05/07/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 
Section 4.4 Addition of statement regarding convulsions and the following “Patients should be advised to inform their physician if they have a history of seizures.”

Section 4.8 Section has been reformatted also additional adverse events anaphylaxis and angioedema have been added

Section 5.3 Information regarding studies in mice and rats has been added

Updated on 09/03/2007 and displayed until 17/04/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 
Section 4.1 

Community acquired and nosocomial pneumonia.

Addition of a statement “Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected.”

Complicated skin and soft tissue infections.

Addition of statement “Zyvox is indicated for the treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.”

Addition of “such as a microbiologist or infectious diseases specialist”  following the statement starting “Linezold should only……”

Deletion of the statement. “Combination therapy will be necessary if a concomitant Gram negative pathogen is documented or suspected."
 
Section 4.4

Addition of warning “In complicated skin and soft tissue infections linezolid should only be used in patients with known or possible co-infection with Gram negative organisms if there are no alternative treatment options available. In these circumstances treatment against Gram negative organisms must be initiated concomitantly.”
 
Section 5.1

Removal of the statement that linezolid has in vitro activity against some Gram negative bacteria.
 
Section 10
 
Change to date of revision of the text
 
 
 
Updated on 19/09/2006 and displayed until 09/03/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 6.3 The shelf life has been updated from 2 to 3 years for the 600 mg presentation.
Updated on 02/08/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update sections 4.4 (Special warnings and precautions for use) and 4.8 (Undesirable effects) of the SPC following receipt of the final variation assessment report for the 5th and 6th PSUR’s’.
Updated on 24/03/2006 and displayed until 02/08/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
Updated on 09/11/2005 and displayed until 24/03/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 29/09/2005 and displayed until 09/11/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/01/2005 and displayed until 29/09/2005
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
  • Addition of Black Triangle
Updated on 10/11/2004 and displayed until 10/01/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 29/09/2004 and displayed until 10/11/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 27/08/2002 and displayed until 29/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/08/2002 and displayed until 27/08/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
  • Change to separate SPCs covering individual presentations

Active Ingredients/Generics

 
  linezolid