Summary of Product Characteristics
last updated on the eMC:
14/04/2009
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 14/04/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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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: 24-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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They key changes to the SmPC are:
- Section 4.6 'Pregnancy' has been updated with additional information on the fact that removal of Mirena or probing of the uterus may result in spontaneous abortion.
- Section 10 ‘Date of Revision of the Text’ has been updated to 24 February 2009.
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Updated on 06/02/2009 and displayed until 14/04/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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: 28-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key change to the SmPC is:
Section 4.2 (Posology and method of administration) of the SmPC was revised to include an instruction for the health care professional to check that the Mirena was still intact after removal.
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Updated on 27/06/2008 and displayed until 06/02/2009
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008
Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0547
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008
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Updated on 07/09/2004 and displayed until 27/06/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 27/06/2002 and displayed until 07/09/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/07/2001 and displayed until 27/06/2002
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Transferred from eMC version 1
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Updated on 10/05/2001 and displayed until 19/07/2001
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Updated on 07/02/2001 and displayed until 10/05/2001
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Updated on 11/01/2001 and displayed until 07/02/2001
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Updated on 13/09/2000 and displayed until 11/01/2001
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Updated on 06/09/1999 and displayed until 13/09/2000
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