Dovato 50 mg/300 mg film-coated tablets
- Name:
Dovato 50 mg/300 mg film-coated tablets
- Company:
ViiV Healthcare UK Ltd
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/07/20
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ViiV Healthcare UK Ltd
Company Products
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 30 July 2020 PIL
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 PIL
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 SmPC
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 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