Nicam 4% w/w Gel

Product Information *

  • Company:

    Dermal Laboratories (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 17 December 2020

File name

NIAG-IPHA.SPC_1608207147.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:Supply through pharmacy only

Updated on 02 April 2019

File name

NIAG-IPHA.PIL.XP4-19-1_1554203449.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 02 April 2019

File name

NIAG-IPHA-SPC_1554198874.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 31 August 2018

File name

NIAG-IPHA.SPC.24.01.17.07.12.17_1535725901.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 26 March 2018

File name

PIL_8731_935.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 March 2018

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 07 December 2017

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.1 (List of excipients), Citric Acid Anhydrous has been updated to Citric Acid.

In section 10 (Date of revision of the text), the date has been changed to January 2017.

Updated on 07 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 March 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Removal/change of distributor

Updated on 17 February 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

Legal category:Supply through pharmacy only

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 "February 2015"

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

Updated on 04 February 2014

Reasons for updating

  • Change of manufacturer

Updated on 29 June 2009

Reasons for updating

  • Change of inactive ingredient

Updated on 24 October 2008

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1 (List of excipients) : The following changes have been made: "Polyoxyethylene Lauryl Ether" has changed to "Macrogol Lauryl Ether" and "Ethanol" has changed to "Ethanol Anhydrous".
 
Section 10 (Date of revision of the text) : The date has changed to "September 2008".

Updated on 22 July 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 - Name of the medicinal product: The strength and pharmaceutical form have been added to the name, as follows: "Nicam 4% w/w Gel
 
Section 9 - Renewal of the Authorisation: The renewal date has changed to: "13 October 2007"

Updated on 29 August 2007

Reasons for updating

  • Change to further information section

Updated on 13 August 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

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 21 July 2005

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 08 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 March 2004

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 13 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only