Updated on 17/05/2011 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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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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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| Date of revision of text on the SPC: 14-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The approved change is the update of the MAH from Cephalon Limited to Cephalon UK Limited: for information it is sections 7, 8, 9 and 10 of the SmPC that have been updated to change the Marketing Authorisation Holder name, the Product Licence number, the date of first authorisation/renewal of authorisation and the date of revision of the SmPC text respectively.
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Updated on 15/11/2010 and displayed until 17/05/2011
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 09-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 of the SPChave been updated to align the text with the Core Safety Profile.
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Updated on 25/08/2010 and displayed until 15/11/2010
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 4.4, 4.5 and 4.8 of the SmPC have been updated as follows:
Addition of a warning on the use of diltiazem in patients with acute porphyria to section 4.4;
Addition of a warning on myasthenia gravis (and exacerbation of muscle weakness) to section 4.4
Change to the statement re. Interaction with statins to section 4.5;
Addition of the adverse event Muscle weakness to section 4.8.
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Updated on 14/04/2010 and displayed until 25/08/2010
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 11-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.4 of the SmPC that has been updated to add information on protection from light and moisture:
”Store in the original package” has been replaced with
“”Store in the original package in order to protect from light and moisture”.
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Updated on 25/08/2009 and displayed until 14/04/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 13-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2 of the SmPC has been updated as follows:
The excipient sucrose has been listed quantitatively, and to include the correct standard statement “For full list of excipients, see section 6.1” at the end of the Section.
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Updated on 09/01/2009 and displayed until 25/08/2009
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Reasons for adding or updating:
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Individual SPC superseded by joint SPC covering several presentations
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| Date of revision of text on the SPC: 17-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Individual SPCs covering different strenghts superseded by joint SPC
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Updated on 17/10/2008 and displayed until 09/01/2009
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Reasons for adding or updating:
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Change to manufacturer contact details
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| Date of revision of text on the SPC: 17-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update MAH address from Oxford to Welwyn Garden City
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Updated on 01/02/2008 and displayed until 17/10/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01/2008 |
| 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): Gingival hypertrophy, thrombocytopenia, and gynaecomastia have been added.
Section 4.5 Interaction with other medicinal products and other forms of interaction, -
CYP3A4 has been identified as the pincipal enzyme involved in the biotransformation of diltiazem. Hence co-administration with other agents that are also substrates for CYP3A4 may result in competitive inhibition of the metabolism of the concomitant agent.
Simultaneous administration with enzyme inducers such as rifampicin and phenobarbital may lead to reduced activity of diltiazem.&
Diltiazem should be used with caution in patients recieving simvastatin and atorvastatin, and patients should be monitored for signs and symptoms of rhabdomyolysis. co-administration of amiodarone with diltiazem leads to an increased risk of bradycardia, AV block and myocardial depression.
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Updated on 13/06/2007 and displayed until 01/02/2008
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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 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 - List of excipients
Changes to printing ink - soya lecithin and dimethylpolysiloxane no longer used. Propylene glycol (E1520) added.
Section 7 - Marketing Authorisation Holder
changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
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Updated on 15/03/2006 and displayed until 13/06/2007
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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 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 14/03/2006 and displayed until 15/03/2006
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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 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Pending awaiting re-submission
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Updated on 13/03/2006 and displayed until 14/03/2006
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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 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Pending awaiting re-submission
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Updated on 28/09/2005 and displayed until 13/03/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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