Retrovir IV
- Name:
Retrovir IV
- Company:
ViiV Healthcare UK Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/21
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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 18 February 2021 PIL
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 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
Section 6 - Change in the address for the marketing authorisation holder, ViiV Healthcare BV Limited
Updated on 23 April 2020 SPC
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 February 2019 SPC
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 7 December 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 7 December 2018 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 14 February 2018 PIL
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 SPC
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 22 May 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 September 2016 SPC
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 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 23 February 2016 SPC
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 PIL
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 SPC
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 SPC
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 8 November 2013 SPC
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 8 November 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 3 July 2012 SPC
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 PIL
Reasons for updating
- Change to drug interactions
Updated on 30 January 2012 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 7 October 2011 SPC
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 PIL
Reasons for updating
- Change to how the medicine works
- Change to dosage and administration
Updated on 23 January 2009 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 March 2008 SPC
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 27 May 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 3 March 2005 SPC
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 7 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)