Updated on 25/04/2012 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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| To update section 4.4 with a Vaso occlusive crisis in patients with sickle cell anaemia and also section 4.8 updated
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Updated on 28/03/2012 and displayed until 25/04/2012
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.7 - Effects on Ability to Drive and Use Machines
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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 6.1 - List of Excipients
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Change to section 6. 6 - Instructions for use, handling and disposal
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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-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Revatio tablets Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.7,4.8, 5.1, 5.2, 6.1, 6.6 & 10
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Updated on 20/01/2012 and displayed until 28/03/2012
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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: 17-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| SmPC Update to section 6.6 to list the exicipients
calcium sulphate and trisodium phosphate in compounding oral vehicle, and minor
typographical updates.
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Updated on 08/11/2011 and displayed until 20/01/2012
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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 4.4 - 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: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Updates to section 4.4, 4.4 and 5.1
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Updated on 13/05/2011 and displayed until 08/11/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 02-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Update to sections 2, 4.1, 4.2, 4.4, 4.5, 4.6,4.7,4.8, 5.1,5.2,5.3,6.3*,6.4*,6.5*,6.6,9,10
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Updated on 06/04/2011 and displayed until 13/05/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 updated to include hypotension as additional side effect with frequency unknown.
The revision date has also been updated.
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Updated on 31/01/2011 and displayed until 06/04/2011
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 21-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Update to section 5.1 of the SmPC
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Updated on 15/10/2010 and displayed until 31/01/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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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 6.2 - Incompatibilities
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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: 23-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Sections 6.2 and 6.6 have been amended to introduce information on diluent compatibility.
Sections 4.2, 4.3 and 4.5 of the Revatio SmPC has been revised.
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Updated on 29/06/2010 and displayed until 15/10/2010
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Re-insertion of black triangle.
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Updated on 20/01/2010 and displayed until 29/06/2010
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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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| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.2 - information in patients with renal hepatic impairment and use in children has been revised
section 4.3 - the following statement was included "Co-administration with nitric oxide donors"
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Updated on 22/07/2009 and displayed until 20/01/2010
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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 4.5 - 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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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Update to sections 4.1 and 5.1 of the SPC with functional class II and long-term survival data and typo’s amended in sections 4.5 and 4.8 for ‘cellulitis’, ‘paraesthesia’ and ‘rifampicine’.
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Updated on 16/10/2008 and displayed until 22/07/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The following text has been removed from Section 5.1:
‘This medicinal product has been authorised under ‘Exceptional Circumstances’. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary’.
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Updated on 02/04/2008 and displayed until 16/10/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8: update to section 4.8 to include the following:
4.8 Undesirable effects
Ear and labyrinth disorders:
Not known- Sudden deafness
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Updated on 13/04/2007 and displayed until 02/04/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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 4.8 addition of "priapism" and "prolonged erection"
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Updated on 23/01/2007 and displayed until 13/04/2007
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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 4.8 - 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: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Posology
Addition of new sentence & deletion of epoprostenol under “use in patients using other medications”
Section 4.8 Undesirable effects
Update of existing text/addition of new summary
Update of the ADR table:
- Addition of 6 new ADRS with frequency common: blood shot eyes/red eyes, blurred vision, nasal congestion
- Change of frequency grouping from common to uncommon for 4 ADRs: visual acuity reduced, diploplia, abnormal sensation in eye.
- Deletion of 1 ADR: weight increased under Investigations MedDRA system organ class.
Section 5.1 Pharmacodynamics
Addition of clinical data:
- First paragraph with summary of study design
- Second paragraph with summary of results for primary efficacy endpoint = 6MWD
- Third and last paragraph with summary of results for secondary efficacy endpoint = mPAP.
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Updated on 25/09/2006 and displayed until 23/01/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 addition of 'skin rash’ and rearranged the adverse events in a table as per MedDRA system organ
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Updated on 19/07/2006 and displayed until 25/09/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.2 - Posology and Method of Administration
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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 4.8 - Undesirable Effects
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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1 update with NAION new safety information:
- added the NAION contraindication and warning/precaution wording SPC section 4.3 & 4.4.
2 rewording of "nitrates contraindication" sentence:
The sentence "The use of Revatio and organic nitrates in any form, at any time is contraindicated" amended to "the use of Revatio in combination with nitrates in any form, at any time is contraindicated".
Amended the sentence with "in combination", to "in co-administration" and removed the term "organic".
Section 2, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.3, 6.6, 9 and 10 of the SmPC updated.
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Updated on 11/07/2006 and displayed until 19/07/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments 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 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/03/2006 and displayed until 11/07/2006
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Reasons for adding or updating:
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