Summary of Product Characteristics
last updated on the eMC:
09/03/2012
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 09/03/2012 and displayed until Current
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Reasons for adding or updating:
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.1 Pharmacodynamic Properties
This section has been completed reworded with the previous text being deleted and new text inserted.
Section 5.2 Pharmacokinetic Properties
This section has been completed reworded with the previous text being deleted and new text inserted, including 6 new sub-headings and corresponding text.
Section 10 Date of Revision of the Text
The date has been updated to September 2011.
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Updated on 15/08/2007 and displayed until 09/03/2012
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1, 4.5, 6.6 - changes to heading titles.
Section 4.4: 'dipyridamole' has replaced full product name in penultimate paragraph.
Sectionn 5.3: Added.
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Updated on 26/07/2004 and displayed until 15/08/2007
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 01/07/2003 and displayed until 26/07/2004
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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 3 - pharmaceutical form
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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 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 6.1 - List of Excipients
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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 23/12/2002 and displayed until 01/07/2003
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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 10 (date of (partial) revision of the text
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Updated on 11/02/2002 and displayed until 23/12/2002
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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 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments 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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Updated on 24/07/2001 and displayed until 11/02/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 24/07/2001
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Reasons for adding or updating:
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