Summary of Product Characteristics
last updated on the eMC:
11/02/2010
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 11/02/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
|
| Date of revision of text on the SPC: 02-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to section 1 Name of medicinal product to Trandate 50 mg, 100 mg, 200 mg and 400 mg film-coated tablets
|
|
Updated on 27/11/2009 and displayed until 11/02/2010
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 01-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| “Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.”
|
|
Updated on 20/04/2009 and displayed until 27/11/2009
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 17-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Date of renewal and revision of text updated to 17 March 2009
|
|
Updated on 15/09/2005 and displayed until 20/04/2009
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 27/09/2004 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Change to joint SPC covering all presentations
|
|
Updated on 12/02/2003 and displayed until 27/09/2004
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
|
Updated on 09/07/2001 and displayed until 12/02/2003
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|