Summary of Product Characteristics
last updated on the eMC:
03/11/2009
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 03/11/2009 and displayed until Current
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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 4.8 - 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: 23-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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1. Trade Name of the Medicinal Product
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SporanoxPORANOX® -Pulse
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4.4. Special Warnings and Precautions for Use
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Addition of hearing loss warning
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4.8. Undesirable Effects
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Complete section has been re-worded
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10. Date of (Partial) Revision of the Text
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Changed from April 2009 to 23 October 2009
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Updated on 20/04/2009 and displayed until 03/11/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 Special Warnings and Precautions for Use
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Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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Change to section 10 Date of Revision of the Text
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Amended to ‘April 2009’
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Updated on 18/09/2008 and displayed until 20/04/2009
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Reasons for adding or updating:
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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: 01-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 - New Company address
Change to section 10 - September 2008
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Updated on 23/07/2008 and displayed until 18/09/2008
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.4 – Special Precautions for Storage
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Store below 30C
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X
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Change to section 10 – Date of revision of the text
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July 2008
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Updated on 18/01/2008 and displayed until 23/07/2008
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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 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.1 – Therapeutic Indications
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Treatment of aspergillosis and candidosis
Treatment of cryptococcosis (including cryptococcal meningitis): in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system.Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection.
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Change to section 4.2 – Posology and |Method of Administration
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1 The duration of treatment should be adjusted depending on the clinical response.
Additional statements on use in children and elderly, renal and hepatic impairment
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Change to section 4.3 – Contra-indications
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New layout and addition of Eletriptan and NIsoldipine
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Change to section 4.4 – Special Warnings and Precautions for Use
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New layout and addition of warnings to children and Elderly and renal and hepatic effects
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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New layout and addition of Eletriptan and Nisoldipine
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Change to section 4.6 – Pregnancy and Lactation
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New layout and new data.
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Change to section 5.1 - Pharmacodynamic properties
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All new information
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Change to section 5.2 - Pharmacokinetic properties
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New layout and new information on special populations
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Change to section 5.3 - Preclinical Safety Data
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All new information
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Change to section 10 – Date of revision of the text
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January 2008
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Updated on 24/08/2007 and displayed until 18/01/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Addition of interaction with Fluticasone
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Change to section 10 – Date of revision of the text
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August 2007
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Updated on 21/09/2004 and displayed until 24/08/2007
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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 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 02/09/2004 and displayed until 21/09/2004
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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 (partial) revision of the text
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Updated on 10/10/2001 and displayed until 02/09/2004
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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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Updated on 24/08/2001 and displayed until 10/10/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 23/08/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 24/02/2000 and displayed until 23/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 24/02/2000
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Reasons for adding or updating:
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