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Entecavir Mylan 0.5 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Entecavir

    *Additional information is available within the SPC or upon request to the company

Updated on 29 June 2022

File name

ie-pl-h-4377-r001-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 29 June 2022

File name

ie-spc-h-4377-r001-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 13 October 2021

File name

ie-pl-h0004377-clean-maht.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 13 October 2021

File name

ie-spc-clean-h0004377-maht.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 20 January 2021

File name

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

Reasons for updating

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

Updated on 16 January 2018

File name

PIL_17399_258.pdf

Reasons for updating

  • New PIL for new product

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)