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Table 1 Licensing Information for Available Medications

From: A systematic review of the safety information contained within the Summaries of Product Characteristics of medications licensed in the United Kingdom for Attention Deficit Hyperactivity Disorder. how does the safety prescribing advice compare with national guidance?

Drug Date of Authorisation (Renewal Date) Date of Last Substantive† Revision to SPC Text Reason for Revision
Strattera® May 2004 (May 2009) 27 September 2011 Addition of contraindication and changes to wording on cardiovascular effects, allergic events, depression, tics, anxiety and overdose (Sections 4.3, 4.4, 4.8, 4.9 and 5.1)
   3 November 2011 Change to wording on hepatic function (Sections 4.4 and 4.8) Addition of comparator data trial outcomes (Section 5.1) Addition of cytochrome P450 wording to Pharmacokinetic properties (Section 5.2)
   25 November 2011 Addition of cardiovascular contraindication and change to wording on cardiovascular status (Sections 4.2, 4.3 and 4.4)
Ritalin® October 1997 (April 2004) 12 May 2011 Expanded wording in the aggression and hostility warnings/overdose section relating to effects of titration from long acting preparations (Sections 4.4, 4.9 and 10)
Concerta® 18-36 mg February 2002 (June 2007) 17 June 2011 Change to prescribing information relating to continuation use in adulthood (Sections 4.2, 4.4, 4.8, 5.1 and 10)
Concerta® 27 mg March 2007 17 June 2011  
Equasym XL® February 2005 10 October 2011 Bruxism added as a common adverse drug reaction under Undesirable Effects (Section 4.8)
Medikinet® February 2007 (November 2008) 3 February 2010 Numerous sections updated as per article 31 Referral
Medikinet XL® 10-40 mg February 2007 (November 2008) 3 February 2010 Update as per article 31 Referral
Medikinet XL® 5 mg January 2011 24 August 2011 Addition to eMC of new SPC for new product
Dexamfetamine** October 1992 Not available Not applicable
  1. Source: http://www.medicines.org.uk/emc/ Accessed 14 November 2011
  2. eMC: electronic Medicines Compendium; SPC: Summary of Product Characteristics
  3. *Relicensed to Shire
  4. **March 2010: Sold to Auden McKenzie who do not subscribe to the eMC
  5. †Substantive defined as any changes to prescribing information which affect safe or effective use of the medication