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Betnovate Scalp Application 0.1% w/v Cutaneous Solution *
Pharmacy Only: Prescription

Updated on 08 December 2020

File name

ie-pl-betnovatescalp-issue5draft1-clean-medicines.ie_1607436925.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_1607436669.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_1545139033.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_1545139091.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 1 & Section 2: update the active substance presentation: the active substance is present as a mass in a volume, the abbreviation w/v should be used, not a mass in a mass

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 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 – 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

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 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 4.2 & Section 6.4 - Warning statements related to flammability
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)