Summary of Product Characteristics
last updated on the eMC:
03/02/2012
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 03/02/2012 and displayed until Current
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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 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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Change to section 4.9 - Overdose
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 25-Jan-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The SPC was updated in sections 4.3, 4.5, 4.6, 4.8 and 4.9 in line with minimum SPC requirements for paracetamol containing products licencesed as 'P'.
The SPC was updated in sections 2, 4.4 and 6.1 with information relating to excipients with a known effect.
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Updated on 25/09/2009 and displayed until 03/02/2012
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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 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 4.9 - Overdose
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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SPC Retired pending re-submission
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| Date of revision of text on the SPC: 01-Jul-2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 –
Remove BP
Section 4.2
Formatting paragraphs
Section 4.4 –
Formatting paragraphs
Section 4.9
Formatting paragraphs
Section – 6.5
Additional sizes and container info
Section – 9
Amendments to authorisation date
Section – 10
Amendments to date
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Updated on 28/09/2006 and displayed until 25/09/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/09/2006 and displayed until 28/09/2006
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Change to address of MA holder
Section 10 - Change to text as above
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Updated on 21/09/2005 and displayed until 27/09/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 24/09/2003 and displayed until 21/09/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/07/2001 and displayed until 24/09/2003
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Reasons for adding or updating:
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Updated on 02/04/2001 and displayed until 03/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 02/04/2001
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Reasons for adding or updating:
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