Betnovate Cream 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-betnovate-cream-issue10draft1-clean med.ie.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 September 2021
File name
ie-pl-betnovate-cream-issue9draft1-clean-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 12 February 2021
File name
ie-pl-betnovate-cream-issue8draft1-clean-medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 28 September 2020
File name
ie-spc-betnovatecream-issue6 draft1_clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 28 September 2020
File name
ie-pl-betnovate-cream-issue7draft1_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 29 October 2019
File name
ie-pl-betnovate-cream-issue 6.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 29 October 2019
File name
ie-spc-betnovatecream-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-betnovate-cream-issue 6.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-betnovatecream-issue5draft1 - 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-betnovatecream-issue4draft6 - 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-betnovatecream-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 08 July 2016
File name
PIL_9820_359.pdf
Reasons for updating
- New PIL for new product
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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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 4.1: Indications:
• 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
Section 4.3 Contraindications, Section 4.6 Fertility, pregnancy and lactation & Section 4.8 Undesirable effects
• 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.
• 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
Section 4.3 Contraindications, Section 4.6 Fertility, pregnancy and lactation & Section 4.8 Undesirable effects
• 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 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 – Updated qualitative and quantitative composition
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 and minor editorial update.
Section 4.9 – Minor QRD update
Section 5.1 – QRD and minor editorial updates
Section 6.1 – Minor editorial updates
Section 6.6 – Minor QRD update
Section 9 – Minor editorial update
Section 10 – Date of revision updated
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 and minor editorial update.
Section 4.9 – Minor QRD update
Section 5.1 – QRD and minor editorial updates
Section 6.1 – Minor editorial updates
Section 6.6 – Minor QRD update
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
Change to address of the MA Holder
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
Minor changes are to
Section 1: Name of Product
Section 2 - Qualitative and Quantitative Composition
Section 6.1 - List of Excipients
Updated on 12 November 2009
Reasons for updating
- Change to product name
Updated on 30 October 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 August 2005
Reasons for updating
- Improved electronic presentation
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)