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RB Pharmaceuticals Limited
103 - 105 Bath Road,, Slough, Berkshire, SL1 3UH, UK
Telephone: +44 (0)1753 217 800
Customer Care direct line: +800 270 81 901

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: 05/01/2011
SPC Temgesic 200 microgram Sublingual tablets

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 05/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   29-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH ownership has resulted in the text in the SPC to be changed to RB Pharmaceuticals
Updated on 25/01/2010 and displayed until 05/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
  • Addition of Legal Category
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2
Text formatted - no change to data

6.3
Data deleted and changed to:
3 years -  Nylon/aluminium/uPVC blister strip.

3 years -  HDPE bottle.

6.4
Data deleted and changed to:
Do not store above 30ºC. Store in the original package -  Nylon/aluminium/uPVC blister strip
Do not store above 30ºC -  HDPE bottle.

6.5
Data deleted and changed to:
Nylon/aluminium/uPVC blister strips of 10 tablets each, packed in cartons of 50 tablets.
HDPE bottle consisting of  50  tablets.

10
Changed from March 2008 to July 2009

11
Addition of Legal Category and CD (Sch 3), POM
Updated on 24/06/2004 and displayed until 25/01/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 20/08/2001 and displayed until 24/06/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 26/07/2001 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 30/03/2000 and displayed until 26/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 30/03/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  buprenorphine hydrochloride