Summary of Product Characteristics
last updated on the eMC:
15/09/2005
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 15/09/2005 and displayed until Current
|
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 25/01/2005 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 4 - Special Precautions for Storage
|
|
Updated on 13/08/2001 and displayed until 25/01/2005
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|