Summary of Product Characteristics
last updated on the eMC:
05/01/2010
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 05/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 08-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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update to section 4.6 “Pregnancy and lactation” to extend the time period between the last administration of fentanyl and re-start of breast feeding from 24 to 48 hours.
In addition, Section 4.9 “Overdose” of the SPC has been amended in order to provide additional symptoms of fentanyl overdosage
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Updated on 03/08/2009 and displayed until 05/01/2010
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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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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 29-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Section 2 (Quality and Quantitative Composition) has been updated to introduce minor typographical / QRD format changes in accordance with the current QRD template;
- In Section 4.8 (Undesirable effects), the list of adverse events has been re-ordered in accordance with the MeDRA organ system classification set out in Appendix 2 of the SPC guideline 2005;
- Section 5.3 (Preclinical safety data) has been updated as requested on the last marketing authorisation renewal by Mutual Recognition Procedure, in order to harmonise the non-clinical information for ACTIQ with the text currently approved for EFFENTORA® buccal tablet, containing the same active substance fentanyl citrate.
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Updated on 11/02/2008 and displayed until 03/08/2009
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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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 the Marketing Authorisation Holder's contact details have changed from 11/13 Fredrick Sanger Road, Surrey Research Park, Guildford, Surrey GU2 7YD, UK to 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT,UK
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Updated on 26/09/2006 and displayed until 11/02/2008
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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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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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Change to section 6.1 - List of Excipients
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 09/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 additional information on excipients such as dextrates, glucose, sucrose, ethanol and propylene glycol
Section 4.4 additional statement on sugar intolerances
Section 4.5 additional statement on interactions with azole antifungals
Section 4.8 reclassified undesirable effects under MedDRA system headings
Section 6.1 provide E numbers and reclassify some terminology
Section 6.4 remove statement about keeping Actiq stored away from children
Section 6.6 add store out of reach and site of children, and advice on the disposal of used and unused medicine
Section 9 update renewal date
Section 10 updated revision of text date
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Updated on 09/01/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 10 (date of (partial) revision of the text
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Updated on 14/12/2005 and displayed until 09/01/2006
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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 10 (date of (partial) revision of the text
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Updated on 04/06/2003 and displayed until 14/12/2005
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Reasons for adding or updating:
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Removal of Black Triangle
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Correction of spelling/typing errors
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Updated on 25/11/2002 and displayed until 04/06/2003
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 06/11/2002 and displayed until 25/11/2002
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Reasons for adding or updating:
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