Retrovir Oral Solution

*
Pharmacy Only: Prescription
  • Company:

    ViiV Healthcare UK Ltd
  • Status:

    No Recent Update
  • Legal 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-os-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-os-issue14 draft2-eMC.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 - Breast-feeding

Update to women living with HIV.

Updated on 08 July 2022

File name

ie-spc-os-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

Date updated

Updated on 08 July 2022

File name

ie-pl-os-issue14draft1-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 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Section 2 What you need to know before you take Retrovir

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.

Protect Other People

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

Updated revision date

Updated on 11 May 2021

File name

ie-spc-os-issue10draft2-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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 2 - Updated to include the amount of propylene glycol present 

Section 4.4 - Section updated with excipeint warning for Propylene glycol and Sodium

Section 4.8 -  Section updated to include most up-to-date contacts for reporting side effects

Section 4.9 -  Overdose section updated with most up-to-date informatin on the product

Section 6.1 - 'contains propylene glycol (E1520)' added to Flavour Strawberry and Falvour White Sugar excipents

 

 

Updated on 11 May 2021

File name

ie-pl-os-issue13draft1-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - Section updated with information on the amount propylene glycol and sodium contained in Retrovir

Section 3 - Step by step instructions on how to take Retrovie has been updated and information on what to do if you take too much Retrovir has also been updated

Section 4 -  Section updated to include most up-to-date contacts for reporting side effects

Section 6 - What Retrovir containts section has been updated to include information on propylene glycol

Section 6 -  Glaxo Operations UK Ltd, Barnard Castle has been removed from list of Manufacturers

 

Updated on 03 March 2021

File name

ie-pl-os-issue12draft1.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Section 6 - Deletion of a Batch Release site from the leaflet

Updated on 23 April 2020

File name

ie-spc-os-issue9draft1 - form 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 23 April 2020

File name

ie-pl-os-issue10draft1 - 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 maarketing authorisation holder, ViiV Healthcare BV Limited

Updated on 28 February 2019

File name

ie-pl-os-issue9draft1-MED.IE.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 February 2019

File name

ie-pl-os-issue8draft4 for meds.ie.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 26 February 2019

File name

ie-spc-os-issue8draft4 for meds.ie.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • 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 2, update to excipients
section 4.2, update to dosing
section 4.4, update to information on excipients
section 4.8, update to uk reporting information
section 6.1, update to excipient to add E number
 

Updated on 07 December 2018

File name

ie-pl-os-issue10draft1 - 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-os-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-os-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 13 February 2018

File name

PIL_9880_257.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 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

Update to sections 4.6 and 5.3 of the SmPC in order to revise the wording regarding pregnancy to reflect current understanding of pharmacovigilance data.

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

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

Update section 4.4 of the SmPC in order to revise the wording regarding mitochondrial dysfunction following assessment of responses to a relevant LEG and after analysis of the final CSR of the Mitochondrial Toxicity in Children (MITOC) Study.

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 4.2 - Posology and method of administration
  • 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 09 October 2015

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer
  • Correction of spelling/typing errors

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

Breastfeeding update to section 4.6 SmPC

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 4.4 - 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

4.4 Add warning regarding viral suppression and deletion of Retrovir therapy.
 
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 - how to report a side effect
  • 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 – disposal has been 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

Changes to:

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 10 February 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 12 December 2011

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 30 March 2009

Reasons for updating

  • Change to dosage and administration
  • Change to how the medicine works

Updated on 23 January 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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 28 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 6.1 - List of excipients
  • 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
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 08 July 2003

Reasons for updating

  • New SPC for medicines.ie

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