Dovato 50 mg/300 mg film-coated tablets *
Pharmacy Only: Prescription

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 December 2021

File name

ieukni-spc-dovato-issue10draft1_1638442946.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 02 December 2021

File name

ieukni-pl-dovato-issue7draft1_1638442844.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 September 2021

File name

ieukni-pl-dovato-issue6draft1_1631005658.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

update to the details MAH LOC representatives 

Updated on 07 September 2021

File name

ieukni-spc-dovato-issue9draft1_1631005306.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 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.1, 4.4, 5.2  - update to lamivudine (3TC) dose with a creatinine clearance (CLcr) ≥30 milliliters (mL)/minute (min) update to lamivudine (3TC) dose with a creatinine clearance (CLcr) ≥30 milliliters (mL)/minute (min)

Section 6.6 - QRD update 

Updated on 23 August 2021

File name

ie-spc-dovato-issue8draft1-clean_1629726232.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to Section 6.3: shelf life extenion from 24 months to 36 months

Updated on 25 May 2021

File name

ie-spc-dovato-issue7draft1-clean_1621958380.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 25 May 2021

File name

ie-pl-dovato-issue5draft1-clean_1621958340.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 November 2020

File name

ie-spc-dovato-issue6draft1_1606295859.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 - update relating to the Breast-feeding sub-section of section 4.6 of the SmPC

Updated on 30 July 2020

File name

ie-pl-dovato-issue4draft1_1596106799.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

section 2: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 4: update to add information regarding weight, blood lipid and blood glucose effects following

Section 6: update to the approval date

Updated on 30 July 2020

File name

ie-pl-dovato-issue4draft1_1596105953.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 4: update to include information regarding weight, blood lipid and blood glucose effects

Section 6: update to the approval date

Updated on 30 July 2020

File name

ie-spc-dovato-issue5draft1_1596105493.pdf

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

section 4.6: update to the pregnancy information in relation to the occurrence of neural tube defects (NTD) with the DTG regimens

Section 10: update to the approval date

Updated on 02 June 2020

File name

ie-spc-dovato-issue4draft1_1591113476.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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change of the 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 02 June 2020

File name

ie-pl-dovato-issue3draft1_1591113383.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 the 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 21 April 2020

File name

ie-spc-dovato-issue3draft1_1587506082.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Removal of the Black Triangle

SmPC section 4.3 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

SmPC section 4.5 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

SmPC section 10 - date of text

Updated on 21 April 2020

File name

ie-pl-dovato-issue2draft1_1587505274.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

the removal of the black triangle for Dovato

Section 4.3 - addition of a contraindication in relation to co-administration with medicinal products with narrow therapeutic windows, that are substrates of OCT-2, including fampridine.

Section 4.5 - other edits to the interaction section including the removal of drug-drug interactions for products no longer authorised in the EU (boceprevir, dofetilide, nelfinavir).

Section 4.8 - the Irish reporting details for the HPRA have been updated to reflect the update to Appendix V of the QRD template.

Updated on 18 February 2020

File name

ie-spc-dovato-issue2draft1_1582015687.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to restricted prescription (C)

Updated on 05 November 2019

File name

ie-spc-dovato-issue1draft1 - for medicines.ie_1572946971.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

MAA approved on the 1 July 2019

Updated on 05 November 2019

File name

ie-pl-dovato-issue1draft1 - for medicines.ie_1572946909.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New MAA licenced in July 2019