Updated on 27/04/2012 and displayed until Current
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Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
SPC: Sections 4.2, 5.1 and 5.2 updated.
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Updated on 29/02/2012 and displayed until 27/04/2012
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Reasons for adding or updating:
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-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| SPC
- update of sections 2, 4.1 to 4.8,
5.1, 5.2, 6.1 to 6.6, 10
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Updated on 11/01/2012 and displayed until 29/02/2012
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Reasons for adding or updating:
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-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6. 6 - Instructions for use, handling and disposal
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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
|
| Sections 4.2, 4.8, 5.2 and 6.6 of the SmPC updated in order to reflect the
updated information on paediatric dosing
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Updated on 19/12/2011 and displayed until 11/01/2012
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Reasons for adding or updating:
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-
Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 01-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Update to section 6.6 with addition of sodium chloride as alternative
reconstitution agent.
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Updated on 16/09/2011 and displayed until 19/12/2011
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Reasons for adding or updating:
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-
Change to section 4.4 - Special warnings and precautions for Use
-
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: 01-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Update to sections 4.4 & 4.5 of the SPC
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Updated on 09/02/2011 and displayed until 16/09/2011
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Reasons for adding or updating:
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-
Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
Updated on 20/01/2011 and displayed until 09/02/2011
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Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 5.1 - Pharmacodynamic Properties
|
| Date of revision of text on the SPC: 01-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Revised SmPC sections
4.4, 4.5 & 5.1
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Updated on 30/09/2010 and displayed until 20/01/2011
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Reasons for adding or updating:
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-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| update sections 4.2, 4.4 & 4.8 of the SPC.
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Updated on 23/09/2009 and displayed until 30/09/2010
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Reasons for adding or updating:
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-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.8
Update to the "Paediatric Use" information in Section 4.8 of the Vfend SPC to include wording around post-marketing data that suggests there might be a higher occurrence of skin reactions (esp. erythema) in the paediatric population compared to adults.
Section 10
Update to revision date
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Updated on 25/02/2009 and displayed until 23/09/2009
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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
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.5 – additional wording on a drug interaction between Voriconazole and the Non-steroidal anti-inflammatory drugs (e.g. Diclofenac and Ibuprofen)
Section 10 – change to revision date
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Updated on 28/10/2008 and displayed until 25/02/2009
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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
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 14-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 9 – change to:
Date of first authorisation: 21 March 2002
Date of last renewal: 21 March 2007
Section 10 – change to date of revision of text.
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Updated on 15/07/2008 and displayed until 28/10/2008
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Reasons for adding or updating:
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-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 20-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.4 - Addition of rare prolonged visual adverse events
Section 4.8 - Additional side effects under very common and common eye disorders
Also reference to clinical trial studies under the visual disturbances section.
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Updated on 25/03/2008 and displayed until 15/07/2008
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Reasons for adding or updating:
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-
Improved Electronic Presentation
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Updated on 25/02/2008 and displayed until 25/03/2008
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Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| 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
|
|
4.2 Posology and method of administration
Additional wording regarding co-administration of Vfend and efavirenz and dose adjustment.
4.3 Contraindications
Removal of statement regarding contraindication of Vfend with efavirenz.
4.4 Special warnings and precautions for use
Addition of additional wording regarding with dosing of alfentanil with Vfend.
4.5 Interaction with other medicinal products and other forms of interaction
Additional wording regarding interaction of alfentanil with Vfend.
Additional statement regarding dose adjustment with efavirenz.
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Updated on 02/08/2007 and displayed until 25/02/2008
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Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6.2 - Incompatibilities
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Sections:
4.3 Contraindications
Additional contraindication regarding use of voriconazole with St John’s Wort
4.4 Special Warnings and precautions for use
Warning regarding the monitoring of pancreatic patients especially children.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction with St John’s Wort.
4.8 Undesirable effects
Additional wording regarding post-marketing reports of pancreatitis in paediatric patients.
Vfend 200 mg powder for solution for infusion ONLY
4.2 Posology and method of administration
Wording regarding electrolyte solutions
6.2 Incompatabilities
Revised wording regarding infusion of concentrated solutions of electrolytes.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Correction
10. DATE OF REVISION OF THE TEXT
Correction
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|
Updated on 25/07/2007 and displayed until 02/08/2007
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Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6.2 - Incompatibilities
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Sections:
4.3 Contraindications
Additional contraindication regarding use of voriconazole with St John’s Wort
4.4 Special Warnings and precautions for use
Warning regarding the monitoring of pancreatic patients especially children.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction with St John’s Wort.
4.8 Undesirable effects
Additional wording regarding post-marketing reports of pancreatitis in paediatric patients.
Vfend 200 mg powder for solution for infusion ONLY
4.2 Posology and method of administration
Wording regarding electrolyte solutions
6.2 Incompatabilities
Revised wording regarding infusion of concentrated solutions of electrolytes.
|
|
Updated on 16/05/2007 and displayed until 25/07/2007
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
2. – Addition of excipient name and addition of reconstitution information for the “powder for solution for infusion” and “powder for oral suspension”.
3. – Simplified description for the pharmaceutical form for the “powder for solution for infusion” and the “powder for oral suspension”.
4.1 – Deleted VFEND from first sentence.
4.2 – Additional paragraph for the “powder for solution for infusion” regarding method of administration.
4.2 – Warning regarding “Use in children”
4.2 – Information about dosing in “adolescents (12 to 16 years of age)”
4.3 – Rewording of sentence regarding “hypersensitivity”
4.4 – “Cardiovascular” section – correction in spelling of “torsades”
4.4 – Addition of a title for information regarding “coadministration of voriconazole and lose dose ritonavir”
4.4 – Addition of a sodium warning for “Vfend powder for infusion”.
4.5 – Administrative changes
4.6 – Pregnancy – administrative change
4.7 – Additional sentence on the “effects on ability to drive and use machines”
4.8 – Re-ordering of information in the table of adverse events by system organ class and frequency.
5.1 – Administrative changes
5.2 – Administrative changes
6.1 – Removal of the amount of sucrose for the “Powder for oral suspension”
6.2 – For the “Powder for solution for infusion”, information has been added regarding “blood products and electrolyte supplementation” and “total parenteral nutrition”
6.3 – For the “Powder for oral suspension” additional information has been added regarding the constituted suspension.
6.4 – Additional sentences regarding “storage” for the Powder for solution for infusion and the powder for oral suspension.
6.5 – Administrative changes
6.6 – More detail regarding handling and disposal
9 – New date for “date of last renewal”
10 – New date for “date of last revision of text”
|
|
Updated on 21/11/2006 and displayed until 16/05/2007
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| sections 4.3, 4.4 and 4.5 to reflect dose adjustment of voriconazole when used with efavirenz.
|
|
Updated on 02/08/2006 and displayed until 21/11/2006
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Reason for Submission: Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
|
Updated on 02/08/2006 and displayed until 02/08/2006
|
Reasons for adding or updating:
|
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Reason for Submission: Change to section 10 (date of (partial) revision of the text
|
|
Updated on 10/07/2006 and displayed until 02/08/2006
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 4.5 Interaction with other medicinal products and other forms of interaction
|
|
Updated on 23/02/2006 and displayed until 10/07/2006
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.3 - Contra-indications
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 28/11/2005 and displayed until 23/02/2006
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
|
|
Updated on 08/09/2005 and displayed until 28/11/2005
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 07/09/2005 and displayed until 08/09/2005
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 25/05/2005 and displayed until 07/09/2005
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 4.4 - Special Warnings and Precautions for Use
|
|
Updated on 01/12/2004 and displayed until 25/05/2005
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6.1 - List of Excipients
|
|
Updated on 13/07/2004 and displayed until 01/12/2004
|
Reasons for adding or updating:
|
-
Change to joint SPC covering all presentations
-
Removal of Black Triangle
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.3 - Contra-indications
|
|
Updated on 05/12/2003 and displayed until 13/07/2004
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 03/09/2002 and displayed until 05/12/2003
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 23/08/2002 and displayed until 03/09/2002
|
Reasons for adding or updating:
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