Vancocin 500 mg powder for concentrate for solution for infusion and powder for oral solution
*Company:
Flynn Pharma LtdStatus:
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 24 June 2022
File name
SmPC 500mg injection IE 2022 06 23.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
MAH address change
Updated on 24 June 2022
File name
PIL text inj 2022 06 23.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH address change
Updated on 14 January 2021
File name
Vancocin Solution PIL IE.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Section 2: Warnings and precautions: addition of warnings against injecting vancomycin in the eyes
Section 2: Warnings and precautions: addition of information regarding skin conditions
Section 2: Other medicines and Vancocin: addition of: piperacillin/tazobactam
Section 4: Possible side effects: addition of information regarding skin conditions
Updated on 14 January 2021
File name
Vancocin 500mg Solution IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: severe bullous reactions have been updated to severe cutaneous adverse reactions
Section 4.4: addition of Eye Disorders
Section 4.8: addition of information regarding severe cutaneous adverse reactions
Section 4.8: addition of toxic epidermal necrolysis
Updated on 13 January 2021
File name
Vancocin 500mg Solution IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 : severe bullous reactions has been amended to information on severe cutaneous adverse reactions
Section 4.4: addition of Eye Disorders
Section 4.8: addition of information regarding severe cutaneous adverse reactions
Section 4.8: addition of toxic epidermal necrolysis
Updated on 28 August 2019
File name
Irish-SmPC-500mg-Injection-approved-230418.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 June 2018
File name
Irish-SmPC-500mg-Injection-approved-230418.docx
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
update the ma holder address
Updated on 16 May 2018
File name
Current-SmPC-vancocin-powder-500mg-approved-180418.docx
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 February 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2012
Reasons for updating
- New SPC for medicines.ie