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Reyataz 300 mg Hard Capsules

Product Information *

  • Company:

    Bristol-Myers Squibb Pharma EEIG

  • Status:

    No Recent Update

  • Active Ingredients :

    Atazanavir sulfate

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
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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 21 September 2020

File name

2020 08 28 UK IE Reyataz 300mg PIL_clean_1600683305.pdf

Reasons for updating

  • XPIL Updated

Updated on 21 September 2020

File name

2020 08 28 UK IE Reyataz 300mg PIL_clean_1600683305.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 21 September 2020

File name

2020 08 28 UK IE Reyataz SmPC_clean_1600682623.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 4.3 and 4.5 - to add a new contraindication and a new drug-drug interaction related to co-administration with lomiptapide
SmPC 4.5 - to add a new drug-drug interaction related to co-administration with DOACs
SmPC 4.5 - to delete drug-drug interaction related to co-administration with boceprevir

Updated on 03 June 2020

File name

2020 04 01 UK IE Reyataz 300mg hard caps PIL_clean_1591195757.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update to Manufacturer: To add Swords Laboratories as an alternative site responsible for batch release. To change the name and amend the address of the site responsible for batch release from CATALENT Anagni

Updated on 03 June 2020

File name

2020 04 01 UK IE Reyataz SmPC_clean_1591195255.pdf

Reasons for updating

  • 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

Date of revision of the text updated to align with the Patient Leaflet Date of revision of the text - 01 April 2020

Updated on 25 February 2019

File name

2019 02 01 UK IE Reyataz 300mg hard caps PIL_clean_1550858777.pdf

Reasons for updating

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

Updated on 22 February 2019

File name

2019 02 01 UK IE Reyataz SmPC_clean_1550858657.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

The address of the Marketing Authorisation Holder has been changed.

Updated on 26 November 2018

File name

20181010-smpc-reyataz-ie-clean_1543228911.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 10 October 2018

File name

20180921-reyataz-pil-300mg-uk-ie-clean_1539163401.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 6 - date of revision

Updated on 10 October 2018

File name

20180921-reyataz-smpc-ie-clean_1539163448.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)

Updated on 25 May 2018

File name

2018 02 22-reyataz-smpc-ie-clean.docx

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

  • Include information on the contraindicated co-administration with lurasidone
  • Section 4.3 Contraindactions
  • Section 4.5 Interaction with other medicinal products and other forms of interaction

Updated on 18 May 2018

File name

2018 02 22-Reyataz-300-pil-uk-ie-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 13 December 2017

File name

PIL_13112_142.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 December 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 02 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 08 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 January 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision
  • Company name change or merger

Updated on 22 June 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 08 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 25 November 2015

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 27 May 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 31 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 13 December 2013

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Removal of black triangle

Updated on 22 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 08 November 2013

Reasons for updating

  • Change to date of revision

Updated on 01 November 2013

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Removal of black triangle

Updated on 12 December 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 September 2012

Reasons for updating

  • Change to, or new use for medicine

Updated on 05 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 17 April 2012

Reasons for updating

  • Change to drug interactions

Updated on 29 November 2011

Reasons for updating

  • Change of trade or active ingredient name
  • Change to, or new use for medicine
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 09 September 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 June 2011

Reasons for updating

  • Change to further information section

Updated on 05 April 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 12 August 2010

Reasons for updating

  • Change to, or new use for medicine

Updated on 22 March 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 25 January 2010

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 24 August 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 22 April 2009

Reasons for updating

  • Change of manufacturer

Updated on 11 March 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Correction of spelling/typing errors
  • Change to date of revision

Updated on 09 September 2008

Reasons for updating

  • Introduction of new pack/pack size

Updated on 14 July 2008

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use

Updated on 06 May 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 May 2008

Reasons for updating

  • Change to warnings or special precautions for use