Pharmacia Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Summary of Product Characteristics last updated on the eMC: 02/02/2012
SPC Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02/02/2012 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 06/01/2012 and displayed until 02/02/2012
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to section 4.7 of the SPC
Update to section 4.9 of the SPC
Updated on 26/04/2011 and displayed until 06/01/2012
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Change to Section 6.5 involving addition of a new 30ml bottle presentation.

 

Updated on 09/03/2011 and displayed until 26/04/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.3 – Shelf-life
Changed from 36 months to 24 months.
Updated on 27/01/2011 and displayed until 09/03/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.5
Updated on 09/09/2009 and displayed until 27/01/2011
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Renewal Approval received August 2009 so dates of renewal and date of last update have been updated.
Updated on 23/01/2009 and displayed until 09/09/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



update section 4.3 - Text amended to align with CDS


update section 4.5 - New interations warning text (previously none)


update section 4.8
- New adverse effects information added


update section 4.9
- New overdose information added

Updated on 23/10/2007 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

7.  Marketing Authorisation Holder

Updated on 31/01/2005 and displayed until 23/10/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 5 - Pharmacological Properties
Updated on 07/01/2003 and displayed until 31/01/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/07/2001 and displayed until 07/01/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2000 and displayed until 17/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   clindamycin phosphate