Updated on 25/01/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 date of revision of the text
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| 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
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Section 6.4 – Special precautions for storage.
Section 10 – Date of revision of the text.
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Updated on 10/12/2010 and displayed until 25/01/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| 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
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Change of ownership from Pharmacia to Pfizer.
Section 7: Marketing Authorisation Holder
Section 8: Marketing Authorisation Number
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Updated on 25/08/2010 and displayed until 10/12/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| 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
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SmPC
Section 7:
Marketing Authorisation Holder
Section 8:
Marketing Authorisation Number
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Updated on 20/07/2010 and displayed until 25/08/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 09/09/2009 and displayed until 20/07/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| 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
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| It had been noted that section 6.5 of the SPC had the container description for two strengths missing. This has now been updated to include these.
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Updated on 20/07/2009 and displayed until 09/09/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.2 - Pharmacokinetic Properties
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| 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
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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.
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Updated on 20/03/2009 and displayed until 20/07/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 the adverse events have been re-organised according to the MedDRA organ system. Two additional ADRs have also been introduced, Intracranial bleeds and Retroperitoneal bleeds.
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Updated on 14/07/2008 and displayed until 20/03/2009
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Nov-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to storage instructions (section 6.4)
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Updated on 14/01/2008 and displayed until 14/07/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.5 – addition of INN names: Indometacin, Etacrynic Acid & Sulfinpyrazone.
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Updated on 24/11/2006 and displayed until 14/01/2008
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change in address from Milton Keynes to Sandwich
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Updated on 06/04/2004 and displayed until 24/11/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Updated on 15/01/2003 and displayed until 06/04/2004
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 12/12/2002 and displayed until 15/01/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/11/2002 and displayed until 12/12/2002
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 21/05/2002 and displayed until 06/11/2002
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 7 - Marketing Authorisation Holder
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Change to section 9 - Date of Renewal of Authorisation
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