Betnovate Ointment 0.1% w/w
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 July 2022
File name
ie-pl-betnovateoint-issue11draft1-clean med.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 July 2022
File name
ie-pl-betnovateoint-issue11draft1-clean med.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 July 2022
File name
ie-pl-betnovateointment-issue10draft2-clean med.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 February 2021
File name
ie-pl-betnovateoint-issue9draft1-clean-medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 September 2020
File name
ie-pl-betnovateoint-issue8draft1_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated reporting details
Updated on 21 September 2020
File name
ie-spc-betnovateoint-issue6draft1_clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Section 4.8 - Undesirable Effects - updated adverse event reporting details
Section 5.3 - Pre-clinical safety data - Addition of 'intrauterine growth retardation' to effects seen in pregnant mice, rats and rabbits
Section 10 - Date of revision of the text - updated to reflect approval date
Updated on 29 October 2019
File name
ie-spc-betnovateoint-issue5.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 October 2019
File name
ie-pl-betnovateoint-issue 7.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 04 February 2019
File name
ie-pl-betnovateoint-issue6draft1 - Meds ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 December 2018
File name
ie-pl-betnovateoint-issue5draft6 - Meds ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 18 December 2018
File name
ie-spc-betnovateoint-issue4draft2 - Meds ie.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2017
File name
PIL_9822_811.pdf
Reasons for updating
- New PIL for new product
Updated on 16 January 2017
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 08 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 July 2016
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- 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
• Some of the terminology used to describe the indications has been modified in line with the ICD-10 classification of skin diseases in order to avoid misinterpretation by non-specialist prescribers and mistranslation into other languages.
• Populations in which use is indicated included (...’indicated for adults, elderly and children over 1 year...’) as per posology and contraindication in children under 1 year of age.
•
Section 4.2: Dosage and administration:
• In line with current medical practice the frequency of application is recommended as once or twice daily. This is a reduction in the recommended frequency of dosing. A review period has been specified.
• Additional mandatory statements have been added concerning use in special populations - children, elderly and those with renal and/or hepatic impairment and aligned with other topical corticosteroids in the GSK portfolio.
• Statement for use in recalcitrant dermatoses (intermittent therapy) has been included
•
Section 4.4 Warnings and precautions:
• Inclusion of additional clarification statements as per GDS and considered informative to the reader; aligns with the other topical corticosteroids in the GSK portfolio; minor editorial updates
•
Sections 4.3, 4.6 and 4.8
• Minor grammar updates
Section 4.9: Overdose:
• Minor update to include QRD sub-headings and inclusion of statement concerning advice recommended by national poisons centre where available for further management; also aligned with other topical corticosteroids in the GSK portfolio.
•
Clinical pharmacology section:
• Section 5.1 of the SmPC has been aligned with other topical corticosteroids in the GSK portfolio; the mechanism of action has been expanded on and is as detailed in the available literature.
• Section 5.2 of the SmPC aligned with other topical corticosteroids in the GSK portfolio.
Section 5.3: Preclinical data:
Updated in line with the SmPC guideline and aligned with other topical corticosteroids in the GSK portfolio
Updated on 08 July 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 02 September 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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 4.3 – Minor editorial updates
Section 4.4 – Minor QRD and editorial updates
Section 4.5 – Minor editorial updates
Section 4.6 – Minor QRD updates
Section 4.8 – QRD updates including addition of adverse reaction reporting statement
Section 4.9 – Minor QRD update
Section 5.1 – QRD and minor editorial updates
Section 5.2 – Minor editorial update
Section 6.1 – Minor editorial updates
Section 9 – Minor editorial update
Section 10 – Date of revision updated
Updated on 02 September 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 17 July 2015
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 20 February 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to:
Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose
Updated on 20 February 2013
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
Updated on 20 November 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 26 November 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The minor changes are to
Section 1: Name of Product
Section 2 - Qualitative and Quantitative Composition
Section 6.1 - List of Excipients
Updated on 19 November 2009
Reasons for updating
- Change to product name
Updated on 26 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 07 January 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 July 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)