Vistabel

*
Pharmacy Only: Prescription
  • Company:

    AbbVie 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

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 4.1 (therapeutic indications), the following indication has been added - for the temporary improvement in the appearance of moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of upper facial lines has an important psychological impact in adult patients.

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

Lagophthalmos (difficulty in completely closing the eye) have been added in sec. 4.8 of the SPC under Post-Marketing data (frequency not known)

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

Tp Update in line with CCDS 16.1 & CSP 4.0.

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

To add Crow's Feet Lines indication

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

 

09/2009 09/2010

 

 

 

 

 

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

None provided

Updated on 02 July 2009

Reasons for updating

  • New PIL for medicines.ie