Ezetimibe/Simvastatin 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mgTablets

Product Information *

  • Company:

    Gerard Laboratories
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 31 May 2021

File name

Ezetimibe Simvastatin SPC v019_1622469033.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 May 2021

File name

Ezetimibe Simvastatin PIL v019_1622468986.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 28 January 2021

File name

ie-spc-de6713-v018 cleanv017-clean_1611837319.pdf

Reasons for 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 January 2021

File name

ie-pil-de6713-v018 cleanv017-clean_1611837264.pdf

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 looks like and pack contents
  • Change to section 6 - date of revision

Updated on 15 January 2021

File name

ie-PIL-de6713-clean-v018_1610715786.pdf

Reasons for updating

  • Change to product name

Free text change information supplied by the pharmaceutical company

Changes in the (invested) name of the medicinal product in CY

Updated on 26 May 2020

File name

ie-SPC-es0279-clean-v015_1590474610.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 May 2020

File name

ie-PIL-es0279-clean-v015_1590474579.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 03 December 2019

File name

ie-spc-es0279-clean-renewal_1575361358.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 November 2019

File name

ie-spc-es0279-clean-v014 Jul19_1573659418.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 12 June 2019

File name

Ezetimibe Simvastatin Package leaflet_1560265740.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 June 2019

File name

Ezetimibe Simvastatin SPC_1560265767.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)