Summary of Product Characteristics
last updated on the eMC:
30/04/2012
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 30/04/2012 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 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: 13-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 and 4.5
Addition of wording related to concomitant treatments and bleeding risk along with editorial changes.
Section 7
Addition of Binger Str. 173
Section 10
Date revised to 04/2012
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Updated on 05/03/2012 and displayed until 30/04/2012
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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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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| Date of revision of text on the SPC: 09-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.3 Contraindications
Minor amendment has been made to this section.
4.8 Undesirable effects
Hepatic function abnormal/Liver function Test abnormal - frequencies have changed from “Uncommon” to “Common”.
Incision site haemorrhage – frequencies have changed from “Rare” to “Uncommon”
5.1 Pharmacodynamic properties
Addition of “see section 4.2 for information on paediatric use” added to last paragraph under Paediatric population.
6.3 Shelf life
The shelf life has been changed from 2 years to 3 years.
The use by date once bottle is opened has been changed from within 30 days to 4 months.
9 Date of first authorisation/renewal of the authorisation
Minor update of the section
10 Date of revision
Date updated to 02/2012
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Updated on 20/12/2011 and displayed until 05/03/2012
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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 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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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-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2
To include recommendations to assess renal function in patients being considered for or already being treated with Pradaxa.
Section 4.3
Added a cross reference to section 4.2 for the contra-indication “patients with severe renal impairment (CrCL <30 ml/min)”
Section 4.4
Minor changes to 3rd paragraph under “haemorrhagic risk”.
Section 10
Date updated to 11/2011
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Updated on 18/08/2011 and displayed until 20/12/2011
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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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