Subutex 8 mg sublingual tablets
*Company:
INDIVIOR EUROPE LIMITEDStatus:
UpdatedLegal 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 21 March 2025
File name
subutex_tabs_SmPC_ie_clean.pdf
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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 21 March 2025
File name
subutex_tablets_ pil__clean.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 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 03 August 2021
File name
spc-clean.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.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.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.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 07 February 2020
File name
SPC-Subutex Sublingual Tablets.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
INDIVIOR EUROPE LIMITED
![Indivior20UK20Limited[1]_1601373530](https://backend-prod.medicines.ie/uploads/files/Indivior20UK20Limited[1]_1601373530.jpeg)
Address:
27 Windsor Place, Dublin 2, Co. Dublin, DO2 DK44, IrelandMedical Information E-mail:
PatientSafetyRoW@lndivior.comMedical Information Direct Line:
80062185