Betacap Scalp Application 0.1% w/w Cutaneous Solution *

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 03 March 2021

File name

BVSA-IPHA.PIL.VP5-20-3_1614783414.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 December 2020

File name

BVSA-IPHA.SPC_1608207001.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 10 November 2020

File name

BVSA-IPHA.SPC_1605008168.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 31 August 2018

File name

BVSA-IPHA.SPC.06.05.15.11.05.15_1535723859.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 20 May 2015

File name

PIL_8656_929.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 May 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "April 2015"

Updated on 11 May 2015

Reasons for updating

  • New SPC for new product

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

Updated on 11 June 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 12 August 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 August 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • 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

In section 1 (Name of the medicinal product) : the name has changed to Betacap Scalp Application 0.1% w/w Cutaneous Solution.
 
In section 4.2 (Posology and method of administration) : the following text has been added : For the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 7 days.
 
In section 6.1 (List of excipients) : the text (a water dispersible derivative of coconut oil) has been deleted and Carbomer has been changed to Carbopol.
 
In section 9 (Renewal of the authorisation) : the date has changed to 11 October 2008.
 
In section 10 (Date of revision of the text) : the date has changed to November 2008.

Updated on 13 August 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.

Updated on 16 May 2005

Reasons for updating

  • 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)

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 March 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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)

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

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