Summary of Product Characteristics
last updated on the eMC:
24/02/2011
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 24/02/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - change from :
Sandoz Limited
200 Frimley Business Park
Frimley
Camberley
GU16 7SR
to:
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
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Updated on 30/09/2010 and displayed until 24/02/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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 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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| Date of revision of text on the SPC: 29-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 3, score line statement added
- In section 4.1, essential hypertension statement abbreviated
- Section 4.2 edited
- Section 4.4 signifcantly edited and pregnancy statement removed
- Section 4.5 edited
- Section 4.6 edited and summarised
- Section 4.7 edited
- In section 4.8, undesirable effects tabulated
- Section 5.1 edited
- Section 5.2 edited
- SEction 5.3 edited
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Updated on 05/08/2010 and displayed until 30/09/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 29-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 3, text edited
In section 4.2, text edited
In section 4.4, pregnancy statement removed
In section 4.5, text edited
In section 4.6, text edited
In section 4.7, vertigo and fatigue added
In section 4.8, layout changed
In section 4.9, text edited
In section 5.3, text edited
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Updated on 23/12/2009 and displayed until 05/08/2010
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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