Updated on 12/01/2012 and displayed until Current
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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: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 (undesirable effects) has been re-written and the following undesirable effects have been added- depression, amnesia, muscle weakness and chills and malaise
Section 5.1 (Pharmacodynamic properties) now includes a paragraph detailing an open-label, 2-year study in 42 patients with type 1 Gaucher disease
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Updated on 20/06/2011 and displayed until 12/01/2012
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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: 16-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Annual EMA reassessment completed and therefore had revision date updated
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Updated on 28/07/2010 and displayed until 20/06/2011
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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: 02-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Annual reassessment of the product
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Updated on 15/12/2009 and displayed until 28/07/2010
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Reasons for adding or updating:
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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-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 10 DATE OF REVISION OF THE TEXT, the date was updated due to the annual re-assessment of the product information.
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Updated on 12/02/2009 and displayed until 15/12/2009
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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 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 4.5 - 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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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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-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.1, amendment to the Gaucher Type 1 indication to specify adult patients only. Addition of indication to treat Niemann-Pick Type C (NPC) disease in paeds and adults.
In section 4.2, specifications were made to the dosing for treatment of Gaucher Type 1, and NPC.
In section 4.4, new data was added that is specific to the treatment of NPC patients.
In section 4.8, there is new data included that relates to experience in treating NPC patients.
In section 5.1, information surrounding use in Gaucher Type 1 has been updated, and new information surrounding NPC has been added.
In section 5.2, there are extensive updates to existing information to take into account the new indication of NPC.
In section 5.3, there were grammatical corrections.
In section 10, the date of revision of text was changed in light of these updates.
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Updated on 13/11/2008 and displayed until 12/02/2009
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 17-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special warnings and precautions for use
The efficacy and safety of Zavesca has not been specificallyevaluated in patients with severe Gaucher disease.
5.1 Pharmacodynamic properties
"...29 patients continued in the extension period. When compared to the measurements at 6 moths, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively). No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.
A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies. An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg.
Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d. for up to 2 years (n = 72). In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements. There were no events of bone crisis, avascular necrosis or fracture during the treatment period."
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Updated on 14/08/2008 and displayed until 13/11/2008
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Reasons for adding or updating:
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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-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| CHMP reassessment and changes to annexes II and III led to new date of revision for the SmPC only.
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Updated on 15/04/2008 and displayed until 14/08/2008
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 04/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Peripheral neuropathy seems to be more common in patients with type 1 Gaucher's Disease compared with the general population. Incidence no longer requires withdrawal from treatment. Removal of wording regarding cognitive dysfunction in Zavesca clinical trials.
Section 4.8 - Reclassification of incidence of undesirable effects as common or very common. Previous wording regarding cognitive dysfunction in Zavesca clinical trials from 4.4 inserted here.
Section 5.1 - Minor spelling / grammer changes.
Section 5.3 - Minor spelling / grammer changes.
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Updated on 08/12/2007 and displayed until 15/04/2008
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Reasons for adding or updating:
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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: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 9 (Date of first authorisation/renewal of the authorisation): Addition of date of renewal to 20 Nov 2007
Section10 (Date of reveison of the text): Changed to 20 September 2007
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Updated on 15/11/2007 and displayed until 08/12/2007
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 03/2007 |
| 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) Additional warning on gastrointestinal events added
Section 5.1 (Pharmacodynamic properties) Section explaining Zavesca authorisation was granted under exceptional circumstances and limited information on the product exists due to the rarity of the disease added.
Section 5.3 (Preclinical safety data) Additional data added regarding animal data showing increased incidence of testicular interstitial cell hyperplasia and adenomas. Additional data added regarding animal data showing increased incidence of of inflammatory and hyperplastic lesions in the large intestine.
Section 6.1 (List of excipients) Additional excipients added.
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Updated on 21/02/2007 and displayed until 15/11/2007
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Correction of spelling/typing errors
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Updated on 30/09/2005 and displayed until 21/02/2007
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 30/01/2004 and displayed until 30/09/2005
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