Reyataz 150 mg Hard Capsules

Product Information *

  • Company:

    Bristol-Myers Squibb Pharma EEIG
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 150mg PIL_clean_1600682984.pdf

Reasons for updating

  • XPIL Updated

Updated on 21 September 2020

File name

2020 08 28 UK IE Reyataz 150mg PIL_clean_1600682984.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_1600682538.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 150mg hard caps PIL_clean_1591195595.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_1591195128.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 150mg hard caps PIL_clean_1550858255.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_1550857882.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 Marketing Authorisation Holder address has been changed.

Updated on 26 November 2018

File name

20181010-smpc-reyataz-ie-clean_1543228769.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-150mg-uk-ie-clean_1539162028.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 date of revision

Updated on 10 October 2018

File name

20180921-reyataz-smpc-ie-clean_1539162072.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

section 4.3 - amendment of text and addition of text 'Co-administration with glecaprevir/pibrentasvir fixed dose combination'

Section 4.5 - addtion of text related to co-administration of REYATAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated. Amendment of table related to interaction between reyataz and other medicinal products

Section 10 – updated date of revision

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-150-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_17036_552.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

  • New individual PIL (was previously included in a combined PIL)