Table 1 Licensing Information for Available Medications
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) |
| Â | Â | 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) |
| Â | Â | 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 |