Abstral Sublingual Tablets *

  • Company:

    Kyowa Kirin International plc
  • 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 12 January 2021

File name

ie-spc-clean_1610455068.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_1607600335.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_1597335963.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_1581928746.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 November 2019

File name

ie-pl-clean_1567073281.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_1567073281.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_1567073234.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_1556704232.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_1556704150.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

In section 4.8 the following has been added to the column "Not known":

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.

EDM Updated on 16 October 2018

File name

2018 Abstral Patient and Carer Guide IRE_1539614475.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 16 October 2018

File name

2018 Abstral Prescriber Guide IRE_1539608144.pdf

Reasons for updating

  • Add New Doc

Updated on 03 September 2018

File name

ie-pl-clean_1535981661.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_1535981548.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 5.5 the addiction of text regarding CYP3A4 inducers.
In section 10 the date of revision of the text

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 28 March 2018

File name

PIL_16563_576.pdf

Reasons for updating

  • New PIL for new product

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 6.3  - Shelf life has been changed from 3 years to 2 years.
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 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 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

None provided

Updated on 21 December 2015

Reasons for updating

  • New PIL for medicines.ie