Summary of Product Characteristics
last updated on the eMC:
27/03/2007
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 27/03/2007 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.8- The sentence 'irrespective of the type of agent used' has been removed
|
|
Updated on 22/02/2007 and displayed until 27/03/2007
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Sections 2, 4.3, 4.4, 4.6, 4.7 and 4.8 updated following a medical safety evaluation and update to the BPI
|
|
Updated on 29/07/2005 and displayed until 22/02/2007
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
