Updated on 02/07/2010 and displayed until Current
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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 4.8 - Undesirable Effects
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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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| Section 4.4
Addition of a cross-reference to section 4.8 and addition of a heading for “Infusion Hypersensitivity Reactions”
Section 4.8
Amendment of frequencies of most common adverse reactions, re-writing of the table of adverse reactions, addition of new terms to the “not known” list, addition of details regarding infusion hypersensitivity reactions and information regarding new terms.
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Updated on 14/04/2010 and displayed until 02/07/2010
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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: 22-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:
Section 7: Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire
Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0001 to PL 16260/0015
Section 9: Date of First Authorisation/Renewal of the Authorisation
Section 10: Date of Revision of Text
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Updated on 11/03/2010 and displayed until 14/04/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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 4.4 - Special warnings and precautions for Use
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Change to section 4.9 - Overdose
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Change to section 5.3 - Preclinical Safety Data
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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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| Date of revision of text on the SPC: 04-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Addition of sodium levels in section 2
- Clarification of age ranges for treatment of children in section 4.2
- Additional warnings in section 4.4
- Update to cyclosporine and other interaction data in section 4.5
- Section 4.6 - Additional information regarding pregnancy and lactation
- Section 4.7 - Change to driving and machinery wording
- Section 4.8 - Update of side effects table to be in line with current guidance including presentation of frequencies
- Re-write of section 4.9 - overdose
- Merger of section 5.3 and 5.4
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Updated on 10/03/2008 and displayed until 11/03/2010
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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: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: MAH contact address changed from The Magdalen centre, Oxford science park, Oxford, OX4 4GA, UK to 1 Albany Place, Hyde way, Welwyn Garden City, Hertfordshire, AL7 3BT
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Updated on 12/06/2007 and displayed until 10/03/2008
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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: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Ltd
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 13/03/2006 and displayed until 12/06/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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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 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 28/09/2005 and displayed until 13/03/2006
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Reasons for adding or updating:
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Change to section 8 - MA number
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Change to section 7 - Marketing Authorisation Holder
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Updated on 28/05/2004 and displayed until 28/09/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 08/07/2003 and displayed until 28/05/2004
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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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Updated on 09/01/2002 and displayed until 08/07/2003
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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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Updated on 05/07/2001 and displayed until 09/01/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 03/04/2001 and displayed until 05/07/2001
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Reasons for adding or updating:
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Updated on 17/11/2000 and displayed until 03/04/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 17/11/2000
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Reasons for adding or updating:
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