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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: 04/04/2012
SPC Mycobutin

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 04/04/2012 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
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 4.5 and 4.8 of the SPC.
Updated on 08/04/2010 and displayed until 04/04/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7 Marketing authorisation Holder: name changed to Pfizer Limited

Section 8: PL number changed to PL 00057/1017

Updated on 30/06/2009 and displayed until 08/04/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Caution statement added to section 4.4 ‘Special Warnings and Precautions for Use’ of the SmPC, to align with the company Core Data: Clostridium difficile associated diarrhoea.
Updated on 24/11/2006 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - Change in address from Milton Keynes to Sandwich
Updated on 19/06/2003 and displayed until 24/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/02/2003 and displayed until 19/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/07/2001 and displayed until 25/02/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 01/03/2000 and displayed until 27/07/2001
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

 
  rifabutin