Reyataz 150 mg Hard Capsules
Product Information *
Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateActive 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)