Summary of Product Characteristics
last updated on the eMC:
03/11/2011
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 03/11/2011 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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - Addition of "Oral Use"
Section 4.3 - Additoin of "Concomitant treatment with oral retinoids due to the risk of increased intracranial pressure (See section 4.5).
Section 4.4 - Confirmation that Efracea yields anti-inflammatory plasma levels added to boxed text
Section 4.6 - Addition of "Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance (see section 5.3). The effect of EFRACEA on human fertility is unknown."
Section 4.8 - Addition of "Benign intracranial hypertension and headache (unknown frequency: cannot be estimated from the available data) have been reported during EFRACEA postmarketing surveillance."
Section 6.1 - Deleted 3cP/6cP from Hypromellose
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Updated on 16/02/2010 and displayed until 03/11/2011
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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 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 26-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The markings on the capsule, as described in section 3 of the SPC, have been updated.
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Updated on 17/09/2009 and displayed until 16/02/2010
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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