Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 30-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 6.3 - Revised shelf life from 2-3 years
In section 10 - Date has been updated
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Updated on 08/09/2011 and displayed until 27/04/2012
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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 4.8 - Undesirable Effects
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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-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4. Special warnings and precautions for use & Section 4.8 Undesirable effects
Important safety information added on the risk of disease progression to Acute Myelogenous Leukaemia (AML) with Nplate® (romiplostim) use in patients with Myelodysplastic Syndrome (MDS).
Section 10 Date of the revision of the text
Date of revision updated.
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Updated on 10/12/2010 and displayed until 08/09/2011
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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 4.8 - Undesirable Effects
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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: 26-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2
Platelet count thresholds at which romiplostim dose should be reduced and interrupted have been lowered to >150x109/L for two consecutive weeks and >250x109/L, respectively in order to minimise the risk of thrombotic/thromboembolic events.
Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with TPO agonists.
Section 4.4
Portal venous thrombosis has been identified in patients with thrombocytopenia associated with hepatic insufficiency that were treated with thrombopoietin (TPO) agonists.
Section 4.8
Reclassification of adverse reactions and addition of an adverse event from spontaneous reporting
Section 10
Changed from 18-Oct-2010 to 26-Nov-2010
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Updated on 02/11/2010 and displayed until 10/12/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4, sub-section Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS).
Information regarding transient blast cell increases has been removed.
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Updated on 01/06/2010 and displayed until 02/11/2010
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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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