Summary of Product Characteristics
last updated on the eMC:
26/03/2009
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 26/03/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 3. error in description of 10 micrograms/hour transdermal patch should read rectangular and not square
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Updated on 04/03/2009 and displayed until 26/03/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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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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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 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 updated to include for a full list of excipients, see section 6.1
Section 4.1 indication has change from severe to moderate and know reads:
Therapeutic indications
Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia
BuTrans is not suitable for the treatment of acute pain.
Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia
BuTrans is not suitable for the treatment of acute pain.
Section 4.2 has been updated to include: BuTrans should be administered every 7th day.
Section 4.3 Pregnacy has been removed (see section 4.6)
Section 4.6 additional text regarding pregnancy:
Therefore BuTrans should not be used during pregnancy and in women of childbearing potential who are not using effective contraception.
Section 5.1 has been updated with new data.
Section 9 and 10 has been updated with the renewal date.
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Updated on 21/06/2007 and displayed until 04/03/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 14/11/2006 and displayed until 21/06/2007
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Reasons for adding or updating:
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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: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 pack sizes updated but not relevant to UK.
Change of date of revision only for uK SPC.
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Updated on 05/09/2006 and displayed until 14/11/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 31/08/2006 and displayed until 05/09/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 (undesirable effects) updated in line with CCDS. new uncommon and rare side effects added.
Section 10 date of revision of text updated
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Updated on 28/09/2005 and displayed until 31/08/2006
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Reasons for adding or updating:
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Change to section 8 - MA number
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Updated on 23/09/2005 and displayed until 28/09/2005
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Reasons for adding or updating:
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