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Betnovate C 0.1% / 3% w/w Cream *
Pharmacy Only: Prescription

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 4.2: Posology has been corrected for the frequency of use of the product
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

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 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 2 - Administrative changes
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

There are Minor Changes to:

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)