Summary of Product Characteristics
last updated on the eMC:
28/10/2008
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 28/10/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.2 - Incompatibilities
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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 9 - Date of first Authorisation/renewal of the Authorisation
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3
First line of text clarified
Section 4.4
Para 2 change from 'administration of paracetamol' to 'administration of product'
Inclusion of 'sight' in the KOOROC warning
Section 4.5
Addition of interactions with bromocriptine with isometheptene; and increased risk of a hypertensive crisis when sympathomimetics are given with MAOIs
Section 4.6
Addition of 'avoid in lactation' in last sentence
Section 4.8
Totally updated
Section 4.9
Totally updated
Section 5.2
Correction of 'accounts' to 'amounts' in first sentence, 3rd para
Section 6.2
Amended to 'not applicable'
Section 6.4
Storage condition updated to current used terminology
Section 6.5
Securitainers deleted from SPC
Section 9
Renewal date added
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Updated on 26/09/2008 and displayed until 28/10/2008
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updated MA holder address to:
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
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Updated on 29/09/2006 and displayed until 26/09/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 01/01/0001 and displayed until 29/09/2006
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Reasons for adding or updating:
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Updated on 19/12/2000 and displayed until 01/01/0001
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Updated on 06/09/1999 and displayed until 19/12/2000
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