Login

Zyvox 600 mg Film-Coated Tablets

*
Pharmacy Only: Prescription

Updated on 02 December 2024

File name

Reg PIL ZY 25_0 600mg IE - clean.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Correction of spelling/typing errors

Updated on 17 October 2024

File name

Reg PIL ZY 24_0 600mg IE - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address.

Updated on 17 October 2024

File name

Reg SPC ZY 22_0 600 mg IE - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7 Change of MAH name and address


Updated on 10 October 2024

File name

Reg PIL ZY 23_0 600mg IE - clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The SPC is not affected. 

The PIL has been updated: manufacturer Freiburg site address update and removal of Pfizer Service Company BVBA, Zaventem.



Updated on 31 July 2024

File name

Reg SPC ZY 21_3 600 mg IE CLEAN.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 'Special warnings and precautions for use' has been updated with the addition of Rhabdomyolysis

Section 4.8 'Undesirable effects' has been updated to add Rhabdomyolysis with a frequency of 'Rare', and ADR reporting details for HPRA in line with the QRD. 

Section 10 : Date of Revision of the Text.


Updated on 30 July 2024

File name

Reg SPC ZY 21_3 600 mg IE CLEAN.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 'Special warnings and precautions for use' has been updated with the addition of Rhabdomyolysis

Section 4.8 'Undesirable effects' has been updated to add Rhabdomyolysis with a frequency of 'Rare', and ADR reporting details for HPRA in line with the QRD. 

Section 10 : Date of Revision of the Text.


Updated on 30 July 2024

File name

Reg PIL ZY 21_2 600mg IE CLEAN.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 20 February 2023

File name

Reg SPC ZY 16_1 600 mg IE.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 December 2020

File name

DEC202085341_Reg PIL ZY 16_0 600mg IE - clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 07 October 2020

File name

Reg PIL ZY 15_0 600mg IE - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 07 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 September 2017

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC is updated with spacing and typo corrections.

Updated on 06 September 2017

File name

PIL_8884_285.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 September 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 04 July 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: change to tablet description in section 3 and removal of printing ink excipients from section 6.1.

Updated on 01 July 2016

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 28 June 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Editorial, formatting and QRD changes to section 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.1, 6.4, 6.5, 6.6, 10

Updated on 27 June 2016

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Addition of manufacturer
  • Change of special precautions for disposal
  • Correction of spelling/typing errors

Updated on 15 June 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Editorial, formatting and QRD changes to section 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.1, 6.4, 6.5, 6.6, 10

Updated on 15 June 2016

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Addition of manufacturer
  • Change of special precautions for disposal
  • Correction of spelling/typing errors

Updated on 27 August 2015

Reasons for updating

  • Addition of manufacturer

Updated on 17 July 2015

Reasons for updating

  • Addition of manufacturer

Updated on 13 October 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.6 – Fertility, pregnancy and lactation: added wording Fertility In animal studies, linezolid caused a reduction in fertility (see section 5.3).

Section 4.8 – Undesirable effects updated in relation to the frequency of side effects

Updated on 08 October 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 09 July 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 April 2013

Reasons for updating

  • Change of manufacturer

Updated on 27 February 2013

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 06 February 2013

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 18 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 23 June 2011

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery

Updated on 04 December 2009

Reasons for updating

  • Change to side-effects

Updated on 28 July 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 20 November 2008

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 August 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 May 2007

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 15 January 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 22 June 2005

Reasons for updating

  • Change to side-effects

Updated on 04 November 2004

Reasons for updating

  • New PIL for medicines.ie