Dovonex Ointment *

  • Company:

    LEO Pharma
  • 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 01 June 2020

File name

ie-pl-dovonex ointment 009Q0D excip update_1591008165.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • In Section 2 the quantity of propylene glycol has been added and wording amended slightly
  • In Section 4 the HPRA contact details for reporting of suspected adverse reactions have been updated

Updated on 01 June 2020

File name

ie-spc-dovonex-oint-009Q0D-excip update_1591007652.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

  • In Section 2 the quantity of propylene glycol has been added
  • In Section 4.8 the HPRA contact details for reporting of suspected adverse reactions have been updated

Updated on 14 January 2020

File name

lbl-dovonex_oint-009GHH-20200108-paraffin-clean_1579020875.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 13 February 2019

File name

spc-dovonex-oint-2167109-qrd-20150928-cl_1550076054.pdf

Reasons for updating

  • Previous version of SPC reinstated

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Previous version of the SmPC has been re-instated following an erroneous upload

Updated on 17 August 2018

File name

spc-dovobet-ointment-2205109-WS084-prac-cl_1534493696.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 09 May 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates made to the following sections of the SmPC in line with the QRD template (including few minor editorial changes);

Section 1
Section 2
Section 4.1
Section 4.2
Section 4.4
Section 4.8
Section 5.1
Section 7
Section 9
Section 10

Updated on 09 May 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 May 2016

File name

PIL_8157_80.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 May 2016

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Product/presentation re-marketed

Updated on 29 November 2006

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated Section 4.1, 4.2, 4.4, 4.5 and 5.3 of the SPC in line with clinical data relating to carcinogenicity and photocarcinogenicity

Updated on 14 August 2006

Reasons for updating

  • Change of active ingredient

Updated on 14 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1: Change to Product Name

Updated on 29 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 July 2004

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2003

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2003

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 July 2003

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • Addition of legal category

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)