Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets *
Company:
Gerard LaboratoriesStatus:
No Recent UpdateLegal 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 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
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
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)