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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: 23/01/2012
SPC Hemabate Sterile 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 23/01/2012 and displayed until Current
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-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 7 - Marketing authorisation holder
Section 8 - Marketing authorisation number
Updated on 27/04/2011 and displayed until 23/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
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
Section 4.3: Section has been reorganised to improve readability.
Section 4.4: Numerous safety updates have been added to this section.
Section 4.5: Section has been adjusted to improve readability.
Section 4.6: Section has been updated to more accurately reflect current available data.
Section 4.7: Section has been updated to more accurately reflect current available data.
Section 4.8: Section has been updated to organise adverse events by MEDRA system organ class.
Section 4.9: Section had been adjusted to improve safety related wording.

Updated on 25/07/2007 and displayed until 27/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 7.1 Change to the MAH address

Section 10 Change in the date of revision
Updated on 07/01/2002 and displayed until 25/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/11/2001 and displayed until 07/01/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/10/2001 and displayed until 08/11/2001
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/08/2001 and displayed until 16/10/2001
Reasons for adding or updating:
  • Change from datasheet to SPC
Updated on 06/09/1999 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  carboprost tromethamine