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Versatis 700 mg medicated plaster

*
Pharmacy Only: Prescription

  • Company:

    Grunenthal Pharma Ltd.

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Lidocaine

    *Additional information is available within the SPC or upon request to the company

  • VERSATIS-[Left].jpeg

Updated on 31 January 2023

File name

m1-3-1-spc-2242-7-1-ie-v10-ipha.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 November 2021

File name

uk_ie-pil-mock-up-vesartis-dual packs.pdf

Reasons for updating

  • Individual PILs superseded by joint PIL

Free text change information supplied by the pharmaceutical company

Introduction of a shared PIL for UK/Ireland for this product. 

File name

m1-3-1-leaflet-2242-7-1-ie-v7-ipha.pdf

Updated on 27 July 2018

File name

m1-3-1-leaflet-2242-7-1-ie-v7-ipha.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 24 July 2018

File name

m1-3-1-spc-2242-7-1-ie-v10-ipha.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 be renewed (B)

Updated on 06 July 2018

File name

m1-3-1-spc-1189-9-1-ie-v9-ipha.docx

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of last renewal updated

Updated on 07 February 2018

File name

PIL_14854_950.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 February 2018

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: Name of Medicinal product    - change in expression of strength from 5% to 700mg 'Versatis 5% 700mg medicated plaster'

Section 2: Qualitative and quantitative composition     - '50mg lidocaine per gram adhesive' has been deleted. E numbers for methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol added.

Section 4.4: Special warning and precautions for use    - E numbers for methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol added.

Section 5.1: Pharmacodynamic properties    - reference to 5% replaced with 700mg

Section 5.2: Pharmacokinetic properties        - reference to 5% replaced with 700mg

Section 6.1: List of excipients            - liquid sorbitol, crystallising

Section 6.3: Shelf life                        - editorial changes

Section 6.4: Special precautions for use (new text I italics)     - After first opening: Keep the sachet tightly closed to protect from light.

Updated on 07 February 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 08 April 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2:
....
If these has been no response to Versatis after this period (during the wearing time and/or during the plaster-free interval) or if any relieving effect can solely be related to the skin protective properties of the plaster, treatment must be discontinued as potential risks may outweigh benefits in this context (see sections 4.4 and 5.1).

Section 4.8:
details on reporting suspected adverse reactions to HPRA

Dare of revision of text:
November 2014

Updated on 08 April 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 25 June 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - clarification of text
Section 4.1 - addition of 'in adults' as part of the indication
Section 4.3 - cross reference to Section 6.1
Section 4.6 - section titles and addition of statement on fertility data
Section 4.9 - addition of comma
Section 9 - dates of authorisations updated
Section 10 - date updated

Updated on 21 June 2013

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 03 February 2012

Reasons for updating

  • Change to improve clarity and readability

Updated on 30 January 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC section 4.2 – statement on long-term use, use in renally impaired patients, use in hepatically impaired patients, data related to children

SPC section 4.6 –statement updated related to animal data

SPC section 5.1 – update to statement on mechanism of action, updates to clinical data information and clarity of data

SPC section 5-2 - typographic

SPC section 5.3 – update to statements on toxicity, embryo-foetal development, male fertility

SPC section 10 - date

Updated on 30 January 2012

Reasons for updating

  • Change to how the medicine works
  • Change to date of revision

Updated on 22 December 2011

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company


5.1. - Amending the text to describe the pain relief on a six point scale

10 - updating date

Updated on 12 December 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 - added: . The plaster can be applied during the day or during the night.

10 - date changed to 25/11/2011

Updated on 08 December 2011

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details

Updated on 27 June 2011

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8
Rewording of adverse events to state:
The most commonly reported adverse reactions were administration site reactions (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles).

Section 10
Date updated:
21/06/2011

Updated on 22 December 2010

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 December 2010

Reasons for updating

  • New PIL for new product