Summary of Product Characteristics
last updated on the eMC:
16/11/2011
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 16/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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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: 02-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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5.3 - Reproductive toxicity details added
Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities including cleft palate and intrauterine growth retardation.
The effect on fertility of betamethasone valerate has not been evaluated in animals.
10 - Date of information updated
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Updated on 11/07/2011 and displayed until 16/11/2011
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Reasons for adding or updating:
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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: 07-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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5.2. This section has been re-formatted with no additional new information.
10. Amended with approval date.
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Updated on 06/07/2011 and displayed until 11/07/2011
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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 revision of the text
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| Date of revision of text on the SPC: 01-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.7 - Section 4.7 of SmPC: updated in line with SmPC guideline for this section.
10.0 - Date of revision
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Updated on 17/10/2007 and displayed until 06/07/2011
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 7 - Marketing Authorisation Holder
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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: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special Warnings and Precautions for Use
Typographical error corrected.
'Further Information' paragraph has been re-instated.
7. Marketing Authorisation Holder
Alternative registered trading style re-instated.
9. Date of First Authorisation/Renewal of Authorisation
Updated to reflect the renewal date and current SPC guidance.
10. Date of the Revision of Text
Updated to reflect the renewal date.
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Updated on 18/02/2005 and displayed until 17/10/2007
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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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Change to section 4.9 - Overdose
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Updated on 10/03/2003 and displayed until 18/02/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 17/08/2001 and displayed until 10/03/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 17/08/2001
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Reasons for adding or updating:
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