Betnovate Scalp Application 0.1% w/v Cutaneous Solution
*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 23 September 2022
File name
ie-pl-betnovatescalp-issue6draft2-clean for med.ie.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 23 September 2022
File name
ie-spc-betnovatescalp-issue6draft2-clean for med.ie.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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
SmPC Section 6.4 Special precautions for storage:
Protect from light. Protect from moisture.
Updated on 08 December 2020
File name
ie-pl-betnovatescalp-issue5draft1-clean-medicines.ie.pdf
Reasons for updating
- 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 08 December 2020
File name
ie-spc-betnovatescalp-issue5draft1-clean-medicines.ie.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 1, Section 2 and Section 4.8
Editorial changes
Section 5.3
Addition of the term 'intrauterine growth retardation' to the list of foetal abnormalities observed in rats, mice and rabbits:
Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities including cleft palate and intrauterine growth retardation.
Section 10
Date of text revision updated
Updated on 18 December 2018
File name
ie-pl-betnovatescalp-issue4draft5 - 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-betnovatescalp-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_8147_388.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 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 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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 4.2: Dosage and administration:
• A review period has been specified.
• Additional information regarding special populations included for consistency in its entirety with the core company global datasheet (GDS).
Section 4.4: Warnings and precautions:
• Inclusion of additional clarification statements as per GDS considered informative to the reader; aligns with the other topical corticosteroids in the GSK portfolio; minor editorial updates.
Section 4.7: Driving and using machines:
• The SmPC guideline requires a statement in cases where the medicinal product has no or negligible influence. Accordingly, a statement has been added.
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 aligns with other topical corticosteroids in the GSK portfolio.
Section 4.1 Indications, Section 4.3 Contraindications, Section 4.6 Fertility, pregnancy and lactation & Section 4.8 Undesirable effects
• Minor grammar updates
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 of trade or active ingredient name
- 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 - how to report a side effect
- 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 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 – Update to adverse reaction reporting details
Section 4.9 – Minor editorial update
Section 5.1 – QRD and minor editorial updates
Section 5.2 – Minor editorial update
Section 6.1 – 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 26 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 28 May 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- 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 - Reporting of suspected adverse reactions
Section 5.1 - Addition of Pharmacotherapeutic group and ATC code
Administrative changes throughout.
Updated on 27 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
- Addition of information on reporting a side effect.
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 10 January 2012
Reasons for updating
- Change of manufacturer
Updated on 29 April 2010
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
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 26 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2007
Reasons for updating
- Improved electronic presentation
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 21 November 2005
Reasons for updating
- Improved electronic presentation
Updated on 11 October 2005
Reasons for updating
- Change to date of revision
Updated on 10 August 2004
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)
GlaxoSmithKline (Ireland) Ltd
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255