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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 02/02/2012
SPC Dalacin T Topical Solution

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:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
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
Update to Section 4..6 of the SPC (Fertility, Pregnancy and Lactation), Update to Section 5.3 of the SPC (Preclinical Safety Data)
Updated on 22/12/2011 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 08/09/2009 and displayed until 22/12/2011
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 08/09/2009
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 23/04/2008 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


6.4.      Special Precautions for Storage

Store below 25°C

 

6.5.      Nature and Contents of Container

Bottle - White high density polyethylene bottle containing 30 ml, 50 ml or 60 ml

Cap – Prolypropylene, linerless screw caps

Or

Prolypropylene, screw cap with polyvinylidene chloride film liner

Applicator – Low-density polyethylene applicator made by Dab-O-Matic
Updated on 23/10/2007 and displayed until 23/04/2008
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 28/09/2004 and displayed until 31/01/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 6.1 - List of Excipients
Updated on 24/08/2001 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 01/03/2000 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 01/03/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  clindamycin phosphate