Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets *

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 17 September 2020

File name

abacavir-lamivudine-spc-clean-renewal_1600348549.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 not be renewed (A)

Updated on 07 November 2019

File name

131-ie-pil-clean-v015-Sep19_1573138490.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 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 November 2019

File name

131-ie-spc-clean-v015-Sep19_1573138213.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties
  • 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 25 June 2019

File name

ie-PIL-ie0636-clean-v013_1561453584.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 January 2019

File name

Aba Lam SPC 20.12.2018_1547044489.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 10 - Date of revision of the text

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

Updated on 20 December 2018

File name

Aba PIL ie-combined-ie0636-clean-mah-2_1545319888.pdf

Reasons for updating

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

Updated on 20 December 2018

File name

ABA SPC ie-combined-ie0636-clean-mah_1545319956.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 14 November 2018

File name

PACKAGE LEAFLET_1542212404.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 04 July 2018

File name

Update SUMMARY OF PRODUCT CHARACTERISTICS 03-07-18.docx

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

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

Updated on 04 July 2018

File name

Upload PACKAGE LEAFLET 03-07-18.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 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 08 June 2018

File name

Upload SUMMARY OF PRODUCT CHARACTERISTICS Abacavir Lamivudine.docx

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 08 June 2018

File name

Upload PACKAGE LEAFLET Abacavir Lamivudine.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 16 April 2018

File name

PIL_17028_267.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 24 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 24 May 2017

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.5 Nature and contents of container

30, 60 or 90 tablets in opaque white (PVC/Aclar/A1 or PVC/PVDC/A1) blister packs, 30 x 1 tablets in perforated opaque white (PVC/Aclar/Al) unit dose blister packs and 30 tablets in white (high density polyethylene) bottles with a polypropylene child resistance closure with printed liner, induction heat sealed and labelled. The bottles contain an activated carbon sachet (100cc) or an activated carbon sachet and oxygen absorber (120cc) to control the moisture in the bottle.

10. DATE OF REVISION OF THE TEXT

November January 20167

Updated on 23 May 2017

File name

PIL_17028_267.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 May 2017

Reasons for updating

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

Updated on 03 January 2017

Reasons for updating

  • New PIL for new product

Updated on 03 January 2017

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided