Subutex 8 mg sublingual tablets *

  • Company:

    INDIVIOR EUROPE LIMITED
  • 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

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 03 August 2021

File name

spc-clean_1627987138.pdf

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

Sleep-related breathing disorders wording added

Updated on 03 August 2021

File name

pil-clean_1627987102.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Sleep-related breathing disorders wording added

Updated on 09 March 2021

File name

pil-subutex-clean public_1615307361.pdf

Reasons for updating

  • Change to name of manufacturer

Free text change information supplied by the pharmaceutical company

Brexit related change

Updated on 22 October 2020

File name

spc-clean_1603369703.pdf

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 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

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

Updated on 22 October 2020

File name

pil-clean_1603369480.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect

Updated on 05 March 2020

File name

PCS 00612 PCS 00625_TR1377968-E_Malta Ireland Subutex 2mg, 8mg tablets_1583425304.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 February 2020

File name

SPC-Subutex Sublingual Tablets_1581094836.pdf

Reasons for updating

  • New SPC for new product

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