Summary of Product Characteristics
last updated on the eMC:
26/09/2011
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 26/09/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 5.3 - Preclinical Safety Data
|
| Date of revision of text on the SPC: 20-Sep-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
4.3. addition of 'intestinal obstruction'
4.7. addition of effects on ability to drive or use machinery
4.8. addtion of 'dyspnoea and/or wheezing' and reorganisation of undesirable effects in this section
4.9. additonal information regarding overdose with very high doses
5.2. addition of plasma half-life data
5.3. additional preclinical safety data
|
|
Updated on 18/05/2011 and displayed until 26/09/2011
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
