Combivir Film-Coated Tablets *

  • Company:

    ViiV Healthcare UK Ltd
  • Status:

    Updated
  • 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 02 September 2021

File name

ieukni -spc-combined-combivir-issue15draft1_1630590179.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update to lamivudine (3TC) dose with a creatinine clearance (CLcr) ≥30 milliliters (mL)/minute (min) - Update to section 4.2 and 4.4 including minor editorial updates across the SPC.

Updated on 02 September 2021

File name

ieukni-pl-combined-combivir-issue12draft1_1630590105.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 06 July 2021

File name

ie-spc-combivir-issue14draft1_1625562243.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

SPC:
Section 4.9 - Overdose information

Updated on 10 March 2021

File name

ie-pl-combivir-issue11draft1-medicines.ie_1615388281.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to MA holder contact details

Updated on 15 December 2020

File name

ie-pl-combivir-issue10draft1_1608033604.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

- update statement on sodium in line with the update EMA excipients guidance

Updated on 15 December 2020

File name

ie-spc-combivir-issue13draft1_1608033472.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

- update statement on sodium in line with the update EMA excipients guidance

Updated on 13 May 2020

File name

ie-pl-combivir-issue9draft1_1589357465.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Change of address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 13 May 2020

File name

ie-spc-combivir-issue12draft1_1589357327.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Change of address of the marketing authorisation holder. ViiV Healthcare BV Limited will be moving from their current location in Huis ter Heideweg 62, 3705 LZ Zeist, The Netherlands to the company's new address Van Asch van Wijckstraat 55H, 3811 LP Amersfoort.

Updated on 18 February 2019

File name

ie-pl-combivir-issue8draft1-MED.IE_1550483806.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 February 2019

File name

ie-spc-combivir-issue11draft1-MED.IE_1550483957.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • 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

Section 7 updated: MAH transfer
Section 4.8: The reporting information for the UK was removed from the IE SPC.
 

Updated on 21 September 2018

File name

ie-spc-combivir_1537526183.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)

Free text change information supplied by the pharmaceutical company

To add Autoimmune Hepatitis (AIH) to SmPC sections 4.4 and 4.8.

Updated on 02 February 2018

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 - how to report a side effect
  • 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

Section 4.4: a minor amendment has been implemented throughout the SmPC in order to update the clinical terminology of Pneumocystis carinii pneumonia to Pneumocystis jiroveci pneumonia.

Section 4.5: add information regarding the interaction between lamivudine and sorbitol

Section 4.8: UK reporting details updated in line with EMA Appendix V

Updated on 02 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 February 2018

File name

PIL_15170_598.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 February 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 26 July 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 6.5 - statements that describe the tamper evident nature of the packaging for Combivir bottles and blisters.

Section 9 - inclusion of date of first authorisation

Updated on 26 July 2016

Reasons for updating

  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 April 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

SmPC section 4.4: Mitochondrial dysfunction following exposure in utero.

Updated on 13 April 2016

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 02 February 2016

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)

Free text change information supplied by the pharmaceutical company

Labelling revisions on Lipodystrophy & Lactic Acidosis

Updated on 02 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 28 September 2015

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 – antiviral activity update

Updated on 09 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Reporting details added to Section 4.8 of SmPC

Updated on 08 June 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 08 May 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Update Section 4.6 of SmPC  to include WHO Breast-feeding guidance. 

Updated on 06 May 2015

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 15 May 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update section 4.4 of the SPC in order to include warnings regarding HIV transmission risk in patients receiving antiretroviral therapy and with effective viral suppression of all antiretrovirals.

Updated on 09 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 13 January 2014

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

.

Updated on 10 January 2014

Reasons for updating

  • Change to MA holder contact details

Updated on 17 May 2013

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)

Free text change information supplied by the pharmaceutical company

·         The following text was added to section 4.4 of the SPC with regards to cladribine

The combination of lamivudine with cladribine is not-recommended (see section 4.5).

·         The following text was added to section 4.5 of the SPC with regards to autoimmune disorders

CYTOTOXICS

Cladribine/Lamivudine

Interaction not studied

 

In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also support a possible interaction between lamivudine and cladribine

Therefore the concomitant use of lamivudine with cladribine is  not recommended

(see section 4.4)

·         The approval date was updated in section 10

Updated on 16 May 2013

Reasons for updating

  • Change to drug interactions

Updated on 09 April 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

·         There are a number of editorial changes in sections 2, 4.3, 4.6, 5.2, 6.3, 6.6 and 10

·         The following text has been added to section 4.4 in relation to autoimmune disorders

Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

·         The following text has been added to section 4.8 in relation to autoimmune disorders

Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment

Updated on 04 April 2013

Reasons for updating

  • Change to side-effects

Updated on 20 October 2011

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 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Changes to Section:

4.4
4.5
4.6
5.3

Updated on 17 October 2011

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 January 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

·         Updated the format of the frequency categorisation

·         Added angiodema as a rare side effect

Updated on 13 August 2010

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Change to Section 7

Updated on 09 October 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

             Section 4.2 and 5.2 added statements regarding crushed tablets

Updated on 29 July 2008

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • 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)

Free text change information supplied by the pharmaceutical company

Renewal: 4.4 Removal of wording re self-administration and pregnancy, change of nomenclature of Pneumacystis carinii pneumonia, timeline of 4 months for liver function and HBV tests added, 4.5 Removal of statement re use in combination with zalcitabine, change of nomenclature of Pneumacystis carinii pneumonia, 4.6 Removed statements re cross-placenta movement of lamivudine and zidovudine, carcinogenicity and mutagenicity and fertility, 4.8 Minor editorial changes, 5.1 Classification updated

Updated on 20 February 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of following:

Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

 

Section 4.8, addition of following:

Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (cART). The frequency of which is unknown (see section 4.4).

Updated on 08 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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