Bepantiseptic First Aid Cream
*Company:
Bayer LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 October 2022
File name
Bepantiseptic Cream SPC Oct 2022 BCH22024.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 08 March 2021
File name
Bepantiseptic First Aid Cream SmPC March 2021.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
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
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 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 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
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
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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
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
Free text change information supplied by the pharmaceutical company
Section 8: New PA number is 1410/47/1
Updated on 26 June 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 26 June 2008
Reasons for updating
- New SPC for medicines.ie