Dovonex Ointment
*Company:
LEO PharmaStatus:
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 30 January 2023
File name
ie-spc-dovonex-oint-009Q0D-excip update.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 June 2020
File name
ie-pl-dovonex ointment 009Q0D excip update.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.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.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.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.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
- New SPC for new product
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
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 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 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
Updated on 14 August 2006
Reasons for updating
- Change of active ingredient
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
- New SPC for medicines.ie
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)