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International Medication Systems (UK) Ltd
208 Bath Road, Slough, Berkshire, SL1 3WE, UK
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: medicalinformationuk@ucb.com
Customer Care direct line: +44 (0)800 953 0183
Medical Information Facsimile: +44 (0)1753 447 690
Summary of Product Characteristics last updated on medicines.ie: 24/07/2009
SPC Atropine Injection (Minijet)

When a pharmaceutical company changes an SPC or PIL, 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 24/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to improve clarity and readability
Date of revision of text on the SPC:   14-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Approval of SPC variations to 4.5 and 4.8 (labelling and leaflet unaffected).


In addition on checking the SPC, several wording and minor detail changes (sections 2, 6.2 – 6.6 and 9 - 10) had been omitted from a previous approval and have been incorporated now.
Updated on 29/08/2007 and displayed until 24/07/2009
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
General update of statutory information
Updated on 16/08/2006 and displayed until 29/08/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Updated on 17/02/2004 and displayed until 16/08/2006
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 24/06/2003 and displayed until 17/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Atropine Sulphate