Retrovir IV
*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 01 September 2022
File name
ie-spc-iv-issue11 draft2-clean.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 - Breast-feeding:
Update to women living with HIV.
Updated on 01 September 2022
File name
ie-pl-iv-issue13 draft2-clean.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 - Breastfeeding
Updated to women living with HIV.
Updated on 08 July 2022
File name
ie-spc-iv-issue11draft1-no header.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)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special Warnings and Precautions for Use
Deletion of paragraph related to transmission of HIV.
Section 4.6 Pregnancy and lactation
Update to Breastfeeding section to remove the condition that mothers infected with HIV must not breastfeed "under any circumstances".
Section 10 - Date of Revision
Updated date of revision
Updated on 08 July 2022
File name
ie-pl-iv-issue13draft1-no header.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
Free text change information supplied by the pharmaceutical company
Section 2 - Breastfeeding
Updated to state that breastfeeding is not recommended (rather than stating "women who are HIV positive must not breastfeed") and that if women are thinking of breastfeeding they should discuss it with their doctor.
Section 2 What you need to know before you take Retrovir
Section entitled "Protect Other People" related to transmission of HIV was deleted in line with CHMP imposed wording.
Section 6 Contents of the pack and other information
Revision date updated
Updated on 11 May 2021
File name
ie-spc-iv-issue10draft2-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 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- 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 4.4 - Sodium excipient content information added
Section 4.8 - Contacts for reporting of side effects have been updated
Section 4.9 - Overdose section updated with most up-to-date information on the product
Section 6.5 - Section updated to include 'chlorobutyl'
Section 10 - Date of revision of text updated
Updated on 11 May 2021
File name
ie-pl-iv-issue12draft1-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Section 2 - Sentence added regarding Sodium content contained in Retrovir
Section 4 - Section updated to include most up-to-date contacts for reporting side effects
Section 6 - Glaxo Operations UK Ltd, Barnard Castle has been removed from list of Manufacturers
Section 6 - Revision date updated
Information for healthcare professionals - Overdose guidance section has been updated
Updated on 18 February 2021
File name
ie-pl-iv-issue11draft1.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Section 6 - removal of an inactive Batch Release site from the leaflet
Updated on 23 April 2020
File name
ie-pl-iv-issue9draft1 - for medicines.ie.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
Section 6 - Change in the address for the marketing authorisation holder, ViiV Healthcare BV Limited
Updated on 23 April 2020
File name
ie-spc-iv-issue9draft1-for medicines.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 - Change in the address for the maarketing authorisation holder, ViiV Healthcare BV Limited
Updated on 28 February 2019
File name
ie-pl-iv-issue8draft2 - Meds ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 February 2019
File name
ie-spc-iv-issue8draft4 for meds.ie.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2, update to dosing
section 4.8, update to uk reporting information
Updated on 07 December 2018
File name
ie-pl-iv-issue7draft1 - Meds ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 07 December 2018
File name
ie-spc-iv-issue10draft2 - Meds ie.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 with the MAH address and section 8 with the PA number
Updated on 23 November 2018
File name
ie-spc-iv-issue9draft2-MED.IE.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)
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.
SmPC Section 4.8 Undesirable events:
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4).
Updated on 14 February 2018
File name
PIL_9881_636.pdf
Reasons for updating
- New PIL for new product
Updated on 14 February 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 22 May 2017
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 2017
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Administrative corrections:
-Sections 4.3 and 4.4: 0.75 or 1.0 x 109/litre has been reformatted to 0.75 or 1.0 x 109/litre
- Section 4.8: 100/mm3 has been reformatted to 100/mm3
- Section 4.4: Added the word “or” between “rifampicin” and “stavudine” in the third paragraph.
Updated on 29 September 2016
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
Updated on 28 September 2016
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 23 February 2016
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 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
Sections 4.4 & 4.8: Class labelling update following PRAC review on Lipodystrophy and Lactic Acidosis.
Administrative changes to all other sections.
Updated on 22 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 12 October 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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 5.1 of SmPC updated, specifically the antiviral activity in vitro antagonism statement
Updated on 27 May 2015
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
Updated on 26 May 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Correction of spelling/typing errors
Updated on 24 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Add contact details for reporting of adverse events.
Updated on 22 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 27 May 2014
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 – a reference to the excipients listed in section 6.1 has been added
Section 4.4 - additional wording added to Immune Reactivation Syndrome (IRIS)
Section 4.8 – Adverse event frequencies have been reformatted
Section 6.6 – “medicinal” added
Updated on 23 May 2014
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 08 November 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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 - Special warnings and precautions for use
Updated on 08 November 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 03 July 2012
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 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Amendment to section 4.4 of the SPC with information regarding exacerbation of anaemia in patients co-infected with HCV and receiving Ribavirin. Amendment to section 4.5 of the SPC to harmonise information on the interaction between Zidovudine and atovaquone.
Amendment to section 4.6 of the SPC to reflect the increased number of exposures during the first trimester of Zidovudine during pregnancy
Updated on 29 June 2012
Reasons for updating
- Change to drug interactions
Updated on 30 January 2012
Reasons for updating
- Change to MA holder contact details
Updated on 07 October 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to:
Section 7 - MARKETING AUTHORISATION HOLDER
Updated on 11 March 2009
Reasons for updating
- Change to how the medicine works
- Change to dosage and administration
Updated on 23 January 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC Section 4.2 To update the paediatric dosage recommendation including the switch from body surface area (BSA)-based dosing (mg/m2) to body weight-based dosing (mg/kg), and the change from three times a day dosing to twice daily (BID) dosing.
SPC Section 4.2 + 5.2 To updated wording regarding administration and pharmacokinetics in patients with Renal impairment.
Updated on 26 August 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 March 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 9 - Date of renewal of authorisation
- 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 to section 1 - trade name
Change to section 2 - qualitative and quantitative composition
Change to section 4.2 - Posology and Method of Administration
Change to section 4.3 - Contra-indications
Change to section 4.4 - Special Warnings and Precautions for Use
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Change to section 4.7 Effects on ability to drive and use machines
Change to section 4.8 - Undesirable Effects
Change to section 5.2 – Pharmokinetic Properties
Change to section 6.4 - Special Precautions for storage
Change to section 9 – Date Of First Authorisation/Renewal Of The Authorisation
Change to section 10 Date of (partial) revision of the text
Updated on 12 March 2007
Reasons for updating
- Improved electronic presentation
Updated on 27 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 03 March 2005
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)