Bepantiseptic First Aid Cream

Product Information *

  • Company:

    Bayer Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through general sale

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 08 March 2021

File name

Bepantiseptic First Aid Cream SmPC March 2021_1615192226.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Updated on 18 May 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 18 May 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 6.5 the tamper evident seal on the tube has been updated to incorporate 'Surlyn'.

Updated on 18 May 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

In section 6.5 the tamper evident seal on the tube has been updated to incorporate 'Surlyn'.

Updated on 30 July 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

Free text change information supplied by the pharmaceutical company

Bepantiseptic – 1410/47/1
15153
www.medicines.ie

(Inserted Text; Deleted Text)

4.8          Undesirable effects

 

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

 

10           Date of revision of the text

December 2012July 2015

Updated on 30 July 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 general sale

Free text change information supplied by the pharmaceutical company

Bepantiseptic – 1410/47/1
15153
www.medicines.ie

(Inserted Text; Deleted Text)

4.8          Undesirable effects

 

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

 

10           Date of revision of the text

December 2012July 2015

Updated on 30 August 2013

Reasons for updating

  • Change to product name
  • Change to section 1 - Name of medicinal product
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 1 (Name of the medicinal product):
The product name has been changed from "Germolene First Aid Cream" to "Bepantiseptic First Aid Cream".

The following text has been added to section 4.8 of the SPC:
"Spontaneous reports of hypersensitivity reactions (hypersensitivity, anaphylactic reaction, anaphylactic shock) have been made; frequency of these reactions cannot be estimated from the available data."

The date of revision of the text has been updated to "December 2012"

Updated on 30 August 2013

Reasons for updating

  • Change to product name
  • Change to section 1 - Name of medicinal product
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 1 (Name of the medicinal product):
The product name has been changed from "Germolene First Aid Cream" to "Bepantiseptic First Aid Cream".

The following text has been added to section 4.8 of the SPC:
"Spontaneous reports of hypersensitivity reactions (hypersensitivity, anaphylactic reaction, anaphylactic shock) have been made; frequency of these reactions cannot be estimated from the available data."

The date of revision of the text has been updated to "December 2012"

Updated on 20 May 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

Section 7: MA holder is now Bayer Limited.

Section 8: New PA number is 1410/47/1

Updated on 20 May 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7: MA holder is now Bayer Limited.

Section 8: New PA number is 1410/47/1

Updated on 26 June 2008

Reasons for updating

  • New SPC for medicines.ie

Updated on 26 June 2008

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale