Summary of Product Characteristics
last updated on the eMC:
10/08/2010
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 10/08/2010 and displayed until Current
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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 - Interaction with other medicinal products 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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| Date of revision of text on the SPC: 28-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4:
Posology and method of administration
Section 4.5:
Interactions
Section 4.8:
Undesirable EffectsTables 1 and
2 have been updated according to the MEDRA SOC. In addition the adverse events
“chest pain” and “pulmonary embolism” have been added in Table
1.
Section 5.1:
Pharmacodynamic properties
Change from
EMEA to EMA
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Updated on 26/05/2010 and displayed until 10/08/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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