Summary of Product Characteristics
last updated on the eMC:
31/08/2007
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 31/08/2007 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 6.2 - Incompatibilities
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
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: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 6.2 amended
MA holder & MA number amended
|
|
Updated on 23/08/2001 and displayed until 31/08/2007
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
