Abstral Sublingual Tablets
*Company:
Grünenthal MedsStatus:
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 20 December 2024
File name
fentanyl-abs-pil-ie-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to marketing authorisation holder
Updated on 20 December 2024
File name
fentanyl-abs-spc-ie-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in MAH from Kyowa Kirin to Grunenthal
Updated on 12 January 2021
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 4.4 Special warnings and precautions for use
Following wording added:
Abstral contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Section 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Changed From:
Date of first authorisation: 2008-02-29
Date of latest renewal: 2013-02-28
To:
Date of first authorisation: 19/09/2008
Date of latest renewal: 28/02/2013
Section 10. DATE OF REVISION OF THE TEXT
Changed From:
May 2019
To:
11 January 2021
Updated on 10 December 2020
File name
Abstral - ie-pl-clean - Nov 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 August 2020
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 February 2020
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 04 November 2019
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 August 2019
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 August 2019
File name
ie-spc-clean.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
In section 4.8. The term "delirium" has been added.
In section 10 the date of revision of the text has been updated to August 2019.
Updated on 01 May 2019
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 May 2019
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Depressed level of consciousness
Loss of consciousness
|
Urticaria |
In section 4.9 the following sateen has been added:
Coma is also known to occur.
In section 10, the date of revision of the text has been updated to March 2019.
File name
2018 Abstral Patient and Carer Guide IRE.pdf
Reasons for updating
- Add New Doc
File name
2018 Abstral Prescriber Guide IRE.pdf
Reasons for updating
- Add New Doc
Updated on 03 September 2018
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 03 September 2018
File name
ie-spc-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2018
Reasons for updating
- 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
In section 10 the date of revision of the text
Updated on 28 March 2018
File name
PIL_16563_576.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 18 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2016
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Section 7 - MAH has changed from PoStrakan to Kyowa Kirin.
Section 10 - Date of revision of the text to May 2016.
Updated on 18 July 2016
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 18 February 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2015
Reasons for updating
- New PIL for medicines.ie