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Pfizer 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: 21/06/2011
SPC Fragmin - Extended Treatment in Oncology (5000, 7500, 10000, 12500, 15000, 18000 I.U Syringes)

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 21/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 list of excipients: Sodium Chloride has been removed.
Updated on 24/01/2011 and displayed until 21/06/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4 – Special precautions for storage.
Section 10 – Date of revision of the text.
Updated on 25/08/2010 and displayed until 24/01/2011
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-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC

Section 7:

Marketing Authorisation Holder

Section 8:

Marketing Authorisation Number
Updated on 20/07/2010 and displayed until 25/08/2010
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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.3:

Contra-indications

Section 4.4:

Special warnings and special precautions for use

Section 4.5:

Interaction with other medicaments and other forms of interactions

Section 4.6:

Pregnancy and lactation

Section 4.8:

Undesirable effects

Updated on 05/08/2009 and displayed until 20/07/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Addition of Black Triangle
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The black triangle had been omitted in error from the previous document. This has now been included in the Trade Names in Section 1.
Updated on 17/07/2009 and displayed until 05/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special warnings and special precautions for use: has been updated to incorporate data on monitoring of anti-Xa levels, interchangeability with other anticoagulants and use in pregnant women (Use in Pregnant women, only affects the multidose vial due to the presence of benzyl alcohol).

has been updated to incorporate data on monitoring of anti-Xa levels, interchangeability with other anticoagulants and use in pregnant women (Use in Pregnant women, only affects the multidose vial due to the presence of benzyl alcohol).

Section 4.6 Pregnancy and lactation: has been revised to include statements concerning use in pregnant women and those who are breast feeding.

has been revised to include statements concerning use in pregnant women and those who are breast feeding.

Section 5.2 Pharmacokinetics: now includes data for special populations.

now includes data for special populations.
Updated on 21/05/2009 and displayed until 17/07/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Addition of Black Triangle
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Black triangle has been added and the document name has been changed/corrected.
Updated on 18/05/2009 and displayed until 21/05/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  dalteparin sodium