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Juluca 50 mg/25 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/02/19

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Summary of Product Characteristics last updated on medicines.ie: 24/2/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd

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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 24 February 2020 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

- SPC section 6.3: Shelf Life Extension from 24 moths to 36 months

- SPC section 4.8: Update to the HPRA reporting details as per update QRD Annex V.

Updated on 19 February 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 6 February 2019 PIL

Reasons for updating

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

Updated on 6 February 2019 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 updated: MAH transfer

Updated on 18 January 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 January 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 4.6 - Pregnancy with information on neural tube defect (NTD) risk in pregnancy.
Section 4.8 - removal of the UK reporting information.

Updated on 14 December 2018 SmPC

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 Warnings:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) 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 5 June 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 May 2018 PIL

Reasons for updating

  • New PIL for new product