Dovato 50 mg/300 mg film-coated tablets

  • Name:

    Dovato 50 mg/300 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Dolutegravir sodium, Lamivudine

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/06/20

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Summary of Product Characteristics last updated on medicines.ie: 2/6/2020

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ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Celsentri film-coated tablets Active Ingredients Maraviroc
Medicine Name Combivir Film-Coated Tablets Active Ingredients Lamivudine, Zidovudine
Medicine Name Dovato 50 mg/300 mg film-coated tablets Active Ingredients Dolutegravir sodium, Lamivudine
Medicine Name Epivir Film-Coated Tablets 150mg Active Ingredients Lamivudine
Medicine Name Epivir Film-Coated Tablets 300mg Active Ingredients Lamivudine
Medicine Name Epivir Oral Solution 10mg/ml Active Ingredients Lamivudine
Medicine Name Juluca 50 mg/25 mg film-coated tablets Active Ingredients Dolutegravir sodium, Rilpivirine Hydrochloride
Medicine Name Kivexa film-coated tablets Active Ingredients Abacavir Sulfate, Lamivudine
Medicine Name Retrovir Capsules 100mg Active Ingredients Zidovudine
Medicine Name Retrovir IV Active Ingredients Zidovudine
Medicine Name Retrovir Oral Solution Active Ingredients Zidovudine
Medicine Name Tivicay film-coated tablets Active Ingredients Dolutegravir sodium
Medicine Name Triumeq 50 mg/600 mg/300 mg film-coated tablets Active Ingredients Abacavir Sulfate, Dolutegravir sodium, Lamivudine
Medicine Name Ziagen Film-Coated Tablets 300mg Active Ingredients Abacavir Sulfate
Medicine Name Ziagen Oral Solution 20mg/ml Active Ingredients Abacavir Sulfate
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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 2 June 2020 SmPC

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 2 June 2020 PIL

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 SmPC

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 PIL

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 SmPC

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 5 November 2019 SmPC

Reasons for updating

  • New SmPC 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 5 November 2019 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New MAA licenced in July 2019