Chlorphenamine 10mg/ml solution for injection
*Company:
Kyowa Kirin International plcStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 November 2018
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 November 2018
File name
ie-spc-clean.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 7 the MAH was changed from Kyowa Kirin Limited to Kyowa Kirin Holdings B.V.
In section 8, the MA number was changed to PA2288/001/002.
In section 10 the date of the revsion of text was updated.
Updated on 15 May 2018
File name
Chlorphenamine_SPC_IE_Clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2018
File name
Chlorphenamine_SPC_IE_Clean.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Revision of the SmPC in line with updated core safety information (CCDSv2), and current clinical guidelines on the treatment of acute allergic reactions. Specifically, to add “anaphylactic reaction” and “central nervous system stimulation” to section 4.8 of the SmPC – other sections of the SmPC also affected.
In addition, a number of updates to align with the current QRD template and, the European Commission guideline “Excipients in the label and package leaflet of medicinal products for human use, July 2003”.
Updated on 23 April 2018
File name
Chlorphenamine_PIL IEClean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 08 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 March 2017
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2017
File name
PIL_15711_772.pdf
Reasons for updating
- New PIL for new product
Updated on 06 March 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 26 May 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of Changes as follows;
Section 7 Marketing Authorisation Holder
Change from;
250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, United Kingdom
to;
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom
Section 10 Date of Revision of the Text
Change from;
04 February 2015
to;
May 2015
Updated on 22 May 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 03 March 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:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of revision of the text updated to 04 Feb 2015 - Please note that approval for change rfrom HPRA received 25 February 2015.
Updated on 26 February 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 10 July 2014
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:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of the following paragraph to Section 4.8
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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie
Date of the Revision of the text changed from Apr 2013 to 11 Feb 2014
Updated on 07 July 2014
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 30 May 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 April 2013
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 April 2013
Reasons for updating
- New PIL for medicines.ie