Betnovate Ointment 0.1% w/w *

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-betnovateoint-issue9draft1-clean-medie_1613141907.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 21 September 2020

File name

ie-pl-betnovateoint-issue8draft1_clean_1600704381.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_1600702727.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_1572368158.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_1572368121.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_1549280834.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_1545135426.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_1545135498.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

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

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

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

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

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

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 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
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

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



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)