Summary of Product Characteristics
last updated on the eMC:
25/01/2010
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 25/01/2010 and displayed until Current
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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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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 5.2 - Pharmacokinetic Properties
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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: 23-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2
Additional paragraph shown below added:
Patients should be advised of the need to take APTIVUS and ritonavir every day as prescribed. If a dose is missed by more than 5 hours, the patient should be instructed to wait and then to take the next dose of APTIVUS and ritonavir at the regularly scheduled time. If a dose is missed by less than 5 hours, the patient should be instructed to take the missed dose immediately, and then to take the next dose of APTIVUS and ritonavir at the regularly scheduled time.
Section 4.4
Spelling of Haemophiliac corrected.
Paragraphs starting Atorvastin and Omeprazole slightly amended
Section 4.5 re-written into a tabular format.
Section 4.8 typographical errors in spelling of paediatric, Diarrhoea, Anaemia and pruritic corrected.
Section 5.2 "Data are awaited to substantiate the influence of food on oral absorption." deleted.
Section 10
Date of revision amended
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Updated on 13/10/2009 and displayed until 25/01/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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