Vistabel
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal 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 10 March 2023
File name
ie_SPC_Vistabel_Type IB_Mephisto sign-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 March 2023
File name
ie_mt_PL_Vistabel_Type IB_Mephisto sign_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 04 October 2022
File name
ie-mt-pl-vistabel-mah transfer.pdf
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 07 July 2022
File name
Vistabel SPC IE.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 April 2022
File name
Vistabel SPC IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 08 April 2022
File name
Vistabel PIL IE & MT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 16 February 2022
File name
ie-spc-vistabel_V13.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 16 February 2022
File name
ie-mt-pl-vistabel_V14.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 27 July 2020
File name
vistabel50u-100u-pil-clean-ie-mt.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 July 2020
File name
vistabel50u100u-spc-clean-ie (1).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 (undesirable effects), the adverse reaction eyelid oedema was added in post-marketing data (frequency not known).
In section 10 (date of revision of the text), the revision date was updated to 13/07/2020.
Updated on 04 December 2019
File name
Vistabel PIL IE + MT - V12.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 December 2019
File name
Vistabel SPC IE - V11.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 (undesirable effects), the frequency of adverse reaction brow ptosis was updated from uncommon to common.
In section 10 (date of revision of the text), the revised date was updated to 25/11/2019.
Updated on 14 January 2019
File name
Vistabel PIL IE V11.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 12 January 2019
File name
Vistabel SPC IE V10.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 30 November 2018
File name
Vistabel PIL IE V9.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 28 November 2018
File name
Vistabel SPC IRE V8.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 3 (pharmaceutical form), the pharmaceutical form was expanded.
In section 4.8 (undesirable effects), dry eye and localised muscle twitching/ involuntary muscle contractions were added.
In section 6.6 (special precautions for disposal and other handling), instructions for reconstitution were added.
In section 10 (date of revision of the text), the revised date was updated to 03/08/18
Updated on 29 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 January 2018
File name
PIL_14320_799.pdf
Reasons for updating
- New PIL for new product
Updated on 29 January 2018
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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)
Free text change information supplied by the pharmaceutical company
In section 4.2 (posology), treatment of forehead lines seen at maximum elevation not recommended in individuals under 18 years of age.
Method of administration - treatment intervals should not be more frequent that every three months. Vistabel should not be injected into a blood vessel when injected in the forehead lines seen at maximum eyebrow elevation. Administration instructions for forehead lines seen at maximum eyebrow elevation added.
In section 4.4 (special warnings and special precautions for use), care should be taken to ensure that Vistabel is not injected into a blood vessel when injected in the forehead lines seen at maximum eyebrow elevation.
In section 4.8 (undesirable effects), preferred terms eyelid ptosis and brow ptosis were added.
In section 5.1 (pharmacodynamics properties), forehead lines clinical data was added.
In section 10 (date of revision of the text), the revised date was added.
Updated on 29 January 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to section 3 - how to take/use
- Change to section 1 - what the product is used for
- Change to information for healthcare professionals
Updated on 04 March 2015
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
Updated on 02 March 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 17 July 2014
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 08 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about driving or using machinery
Updated on 22 January 2014
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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 January 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 21 November 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
sec. 4.4 and 4.8 have been updated with CSP V3:
- moving existing wording in sec. 4.4
- moving existing side effects in sec. 4.8 to be under appropriate system organ class
- adding ADR reposting statement
Updated on 25 October 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 29 July 2013
Reasons for updating
- Change to packaging
Updated on 02 November 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 October 2012
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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 has been updated with methods for disposal.
Section 4.4 has been updated with warnings regarding vulnerable anatomical structures; patients with unrecognised neuromuscular disorders; swallowing and breathing difficulties which can be serious and can result in death; injection related warnings.
Section 4.5 has been updated with unknown effects of administering different botulinum neurotoxin serotypes at the same time or within several months of each other.
Section 4.6 has been updated with information regarding fertility.
Section 4.7 has been updated.
Section 4.8 has been updated with regards to the frequency of reporting of some adverse events and post marketing data.
Section 4.9 has been updated.
Updated on 19 October 2012
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 29 July 2011
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
Summary of Changes to VISTABEL IE Summary of Product Characteristics (SPC)
The current VISTABEL IE SPC is dated 29th September 2010
This supersedes SPC dated 19th September 2009
|
Section Number |
Subject |
Change |
|
6.3 |
Shelf Life |
Test Removed/Added
3 years. After reconstitution, immediate use of the solution is recommended; However, physicochemical stability for 24 hours at +2°C - 8°C has been demonstrated.
|
|
7 |
MARKETING AUTHORISATION HOLDER |
Text Removed/Added
Allergan Pharmaceuticals Ireland Castlebar Road Westport County Mayo Ireland
|
|
10 |
DATE OF REVISION OF THE TEXT |
Text Removed/Added
|
Key:
Unchanged text appears as follows: eg Paediatric population
Added text appears as follows: eg Uveitis
Updated on 22 July 2011
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 26 April 2010
Reasons for updating
- Change to date of revision
- Change due to harmonisation of PIL
Updated on 08 July 2009
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
Updated on 02 July 2009
Reasons for updating
- New PIL for medicines.ie