Chlorphenamine 10mg/ml solution for injection

Product Information *

  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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 13 November 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 November 2018

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

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

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

Reasons for updating

  • Change to section 4 - possible side effects

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

In section 7 - MA transfer to Kyowa Kirin$0In section 8 - Change of Marketing Authorisation number $0$0In section 10 - Date of Revision of the text $0

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 06 March 2017

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

Change to section 4.8 in who to report an AE - change from IMB to HPRA

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 6764971Fax: +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

None provided

Updated on 23 April 2013

Reasons for updating

  • New PIL for medicines.ie