Summary of Product Characteristics
last updated on the eMC:
23/05/2012
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 23/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 08-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5 of the SPC was updated
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Updated on 17/01/2011 and displayed until 23/05/2012
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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 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: 07-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Dosage as per Intravenous and intramuscular routes has been added.
Section 4.3: Operative intervention in the biliary tract has been added.
Section 4.4: The section has now been been divided warnings na dprecautions
Section4.5: Interaction with opoid premedication, barbiturates, fluconazole, MAO has been added.
Section4.6: Some data has been edited.
Section 4.8: Some new symptoms have been added.
Section 4.9: Some precautions and treament have been added.
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Updated on 09/09/2010 and displayed until 17/01/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 31-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 1) National Type II Category C.I.2.b variation submitted to the MHRA on 19th May 2010 to update section 4.5 of the SPC inline with the UK innovator SPC for Sublimaze™ (Janssen-Cilag Ltd) PL 00242/5001R revised on 04 September 2009 and the Irish innovator SPC for Sublimaze 50 micrograms/ml solution for Injection (Janseen-Cilag Ltd) (PA 748/44/1 revised on 21 July 2009) for the above mentioned product Licence.
2) National Type II Category C.I.2.b variation submitted to the MHRA on 19th May 2010 (CRN No.: 0035) to update sections 4.3, 4.9 & 5.1 of the SPC inline with the Irish innovator SPC for Sublimaze 50 micrograms/ml solution for Injection (Janseen-Cilag Ltd) PA 748/44/1 and revised on 21 July 2009 and also in line with the approved Irish SPC for our products Fentanyl Citrate 500 micro grams in 10 ml Solution for Injection PA 73/122/2 and Fentanyl Citrate 100 micrograms in 2 ml Solution for Injection PA 73/122/1, approved on 23 August 2006 additional changes being made as a result of further review of literature. The Patient Information leaflet has been updated to reflect the changes done on the SPC.
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Updated on 23/08/2010 and displayed until 09/09/2010
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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 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.2 and 4.4 of the SPC in line with the recommendations of the Paediatric Assessment Report for European Article 45 of Regulation (EC) No 1901/2006 worksharing procedures, published on the MHRA website for the molecule Fentanyl
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Updated on 06/08/2009 and displayed until 23/08/2010
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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