Summary of Product Characteristics
last updated on the eMC:
10/08/2011
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 10/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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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-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.2 and 10 has been updated.
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Updated on 03/03/2011 and displayed until 10/08/2011
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- section 4.7 has been updated
- section 10 date of revision changed to February 2011
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Updated on 25/08/2009 and displayed until 03/03/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 has been updated to reflect a name change of the medicinal product to RINATEC 21 micrograms per metered dose, Nasal Spray solution
Section 10 date has been revised to March 2009
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Updated on 11/09/2008 and displayed until 25/08/2009
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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 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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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: 01-Nov-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 – heading update and the addition of ‘solution’ into the name
Sections 4.4, 4.5 and 6.5 – minor update to the headings only
Section 10 – Date change
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Updated on 16/12/2004 and displayed until 11/09/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 26/07/2004 and displayed until 16/12/2004
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Reasons for adding or updating:
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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 29/08/2002 and displayed until 26/07/2004
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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 - 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 4.6 - 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 4.9 - Overdose
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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. 6 - Instruction for Use/Handling
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Updated on 20/08/2001 and displayed until 29/08/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 16/08/2001 and displayed until 20/08/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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