Betnovate C 0.1% / 3% w/w Cream *
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
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 12 February 2021
File name
ie-pl-betnovateccream-issue7draft1-clean-medie_1613141442.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 January 2021
File name
ie-pl-betnovateccream-issue6draft1_for medicines.ie_1611328967.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 - date of revision
Updated on 22 January 2021
File name
ie-spc-betnovateccream-issue4draft2_for medicines.ie_1611328755.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Addition of flammability warning
Section 4.8 - Update to HPRA reporting details
Section 10 - Update to date of revision
Updated on 13 February 2019
File name
ie-pl-betnovateccream-issue5draft1 for Medicines.ie_1549986692.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 January 2018
File name
PIL_9821_432.pdf
Reasons for updating
- New PIL for new product
Updated on 05 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 January 2018
Reasons for updating
- 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 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 4.4: To include warning regarding visual disturbances
SPC Section 4.8: To include undesirable effect for blurred vision
Updated on 05 January 2018
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
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 19 February 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 06 January 2015
Reasons for updating
- 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 4.3 - 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 4.7 - Effects on ability to drive and use machines
- 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 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- 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- Addition of indications
Section 4.2 - Additional information on posology and administration
Section 4.3 - Additional contraindications
Section 4.4 - Additional warnings and an update of information
Section 4.5 - Addition of interactions
Section 4.6 - Updated information
Section 4.7 - Additional information
Section 4.8 - Additional information and reporting of adverse events
Section 4.9 - Additional information
Sections 5.1, 5.2 5.3 - Additional information
Section 6.6 - Updated information
Updated on 05 January 2015
Reasons for updating
- 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
- Change to date of revision
- Addition of information on reporting a side effect.
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 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 09 March 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 August 2005
Reasons for updating
- Improved electronic presentation
Updated on 24 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 01 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)