Juluca 50 mg/25 mg film-coated tablets
*Company:
ViiV Healthcare UK LtdStatus:
No Recent UpdateLegal 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
Updated on 30 January 2023
File name
ieukni-SPC-juluca-issue17draft1-clean - no header.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 January 2023
File name
ieukni-pl-juluca-issue13draft1-clean - no header.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - what the product contains
- Removal of Black Inverted Triangle
Updated on 05 October 2022
File name
ieukni-spc-juluca-issue16draft1-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 September 2022
File name
ieukni-spc-juluca-issue15draft1-clean.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)
Updated on 22 September 2022
File name
ieukni-pl-juluca-issue12draft1-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 September 2022
File name
ieukni-spc-juluca-issue14draft2-clean_compendia.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 medical prescription which may not be renewed (A)
Updated on 01 September 2022
File name
ieukni-pl-juluca-issue11draft2-workingcopy-clean_compendia.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 14 July 2022
File name
ieukni-spc-juluca-issue14draft1-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 14 July 2022
File name
ieukni-pl-juluca-issue11draft1-workingcopy-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 09 March 2022
File name
ieukni-spc-juluca-issue13draft1.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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
| PRAC recommendation to add panic attack (impact to section 4.8 of SmPC and section 4 of PIL) |
Updated on 09 March 2022
File name
ieukni-pl-juluca-issue10draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 February 2022
File name
ieukni-spc-juluca-issue12draft1-compendia.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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to add “completed suicide” to the list of adverse drug reactions (ADRs) with frequency ”rare”. |
Updated on 24 February 2022
File name
ieukni-pl-juluca-issue9draft1-compendia.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 October 2021
File name
ieukni -spc-combined-juluca-issue11draft1.pdf
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 and Section 4.8 - add weight and metabolic parameter increases
Updated on 21 October 2021
File name
ukgb-spc-juluca-issue12draft1.pdf
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 and Section 4.8 - add weight and metabolic parameter increases
Updated on 13 September 2021
File name
ieukni -spc-combined-juluca-issue11draft1.pdf
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
- 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 section 4.4 and 4.8 to to add weight and metabolic parameter increases
Updateto section 4.5 to add some drug interactions
Updated on 13 September 2021
File name
ieukni -pl-combined-juluca-issue8draft1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
update to section 4 as a resut of aPRAC recommendation to add weight gain and metabolic parameter increases
Updated on 04 June 2021
File name
ie-spc-juluca-issue10draft1.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 medical prescription which may not be renewed (A)
Updated on 04 June 2021
File name
ie-pl-juluca-issue7draft1.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 21 September 2020
File name
ie-spc-juluca-issue9draft1.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
update sections 4.8 and 5.1 of the SmPC with information on resistance in vivo and clinical efficacy, based on final results from Phase III studies 201636 (SWORD-1) and 201637 (SWORD-2). In addition, information regarding “Changes in laboratory biochemistries” with the Week 148 data are also updated.
Updated on 30 July 2020
File name
ie-pl-juluca-issue6draft1.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- 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 6: update to the approval date
Updated on 30 July 2020
File name
ie-spc-juluca-issue8draft1.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 medical prescription which may not be renewed (A)
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-juluca-issue7draft1.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 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-juluca-issue5draft1.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-pl-juluca-issue4draft1.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
Free text change information supplied by the pharmaceutical company
Section 2 - 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 2 - 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 - Irish reporting details for the HPRA have been updated in section 4 of the PIL to reflect the update to Appendix V of the QRD template.
Section 6 - date of text
Updated on 21 April 2020
File name
ie-spc-juluca-issue6draft1.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC section 4.3 - 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 24 February 2020
File name
ie-spc-juluca-issue5draft1.pdf
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
File name
ie-pl-juluca-issue3draft1-MED.IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 06 February 2019
File name
ie-pl-juluca-issue3draft1 for Meds.ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 06 February 2019
File name
ie-spc-juluca-issue4draft1 for Meds.ie.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
Section 7 updated: MAH transfer
Updated on 18 January 2019
File name
ie-pl-juluca-issue2draft1-MED.IE.pdf
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
File name
ie-spc-juluca-issue3draft1-ME.IE.pdf
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
File name
ukie-spc-juluca-issue2-medicines compendium.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
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 05 June 2018
File name
ukie-spc-juluca-formedicinesie.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018
File name
ukie-pl-juluca-issue1draft1 for medicines compendia.pdf
Reasons for updating
- New PIL for new product