Entecavir Mylan 0.5 mg film-coated tablets *

  • Company:

    Gerard Laboratories
  • 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

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 20 January 2021

File name

ie-ema-pil-h004037-en-clean_1611155720.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 January 2021

File name

ema-spc-clean-h0004377-IE var 0005_1611154984.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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 20 January 2021

File name

ema-pl-h0004377-clean var 0005 IE - both strengths_1611154891.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • 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 21 April 2020

File name

ema-spc-clean-h0004377-IE var 0004_1587495956.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 21 April 2020

File name

ema-pl-h0004377-clean var 0004 IE - both strengths_1587495905.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to local Representatives of MAH

Updated on 11 March 2019

File name

ema-pl-h0004377-clean art61 IE_1552303123.pdf

Reasons for updating

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

Updated on 16 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 16 January 2018

File name

PIL_17399_258.pdf

Reasons for updating

  • New PIL for new product