Vancomycin 500mg Powder for oral solution *
Pharmacy Only: Prescription

  • Company:

    Flynn Pharma Ltd
  • Status:

    No Recent Update
  • Legal 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 14 January 2021

File name

Vancocin Solution PIL IE_1610623507.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_1610617409.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_1610561336.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_1566979691.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

update SmPC with furosemide interaction and update EUCAST data

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

update SmPC with furosemide interaction and update EUCAST data

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

None provided

Updated on 16 July 2012

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided