Summary of Product Characteristics
last updated on the eMC:
29/09/2009
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 29/09/2009 and displayed until Current
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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: 26-Apr-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 27/06/2007 and displayed until 29/09/2009
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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 4.4 - Special warnings and precautions for Use
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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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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to add 'May be chewed or sucked" to posology, naming of excipients and removal of 'to protect from moisture'; addition of soybean oil warning in contraindications; update to warnings.
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Updated on 16/03/2007 and displayed until 27/06/2007
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update Section 4.9 Overdosage in line with MHRA guidelines on gastric lavage
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Updated on 15/03/2007 and displayed until 16/03/2007
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to Section 4.9 Overdose in line with MHRA guidelines on Gastric Lavage
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Updated on 27/05/2004 and displayed until 15/03/2007
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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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 4.3 - 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 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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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 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Updated on 10/02/2003 and displayed until 27/05/2004
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 07/02/2003 and displayed until 10/02/2003
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 23/10/2001 and displayed until 07/02/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/07/2001 and displayed until 23/10/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/09/1999 and displayed until 12/07/2001
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Reasons for adding or updating:
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