Zyvox 600 mg Film-Coated Tablets
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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, 10Updated 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, 10Updated 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
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