Summary of Product Characteristics
last updated on the eMC:
05/10/2010
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 05/10/2010 and displayed until Current
|
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-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 4.4 - Correction - In patents with pre-existing prolonged QT intervals, use of alternative treatments is to be considered.
|
|
Updated on 26/08/2010 and displayed until 05/10/2010
|
Reasons for adding or updating:
|
-
Change to section 5.2 - Pharmacokinetic Properties
|
| Date of revision of text on the SPC: 24-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 5.2 Pharmacokinetic properties
Addition of details for: absorption, distribution, biotransformation, elimination and special populations.
|
|
Updated on 22/07/2010 and displayed until 26/08/2010
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 07-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.3 Contraindications updated to include sucrose warning
Section 4.4 Removal of sucrose warning
Section 4.8 Regrouping of side-effects according to MedDRA system organ class and addition of side effect - Fixed drug eruption
|
|
Updated on 20/05/2010 and displayed until 22/07/2010
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 14-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
6.3 - Shelf life reduced to 2 years
6.4 - Removal of storage conditions to store product below 25 degrees C.
|
|
Updated on 24/03/2010 and displayed until 20/05/2010
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 5.1 - Pharmacodynamic Properties
|
| Date of revision of text on the SPC: 15-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 5.1 - pharmacodynamic information from CCDS added
Section 1: Change of name of product to 10 mg/5ml
|
|
Updated on 04/02/2010 and displayed until 24/03/2010
|
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-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Addition of the following warning to section 4.4. of SPC:
Caution is needed in patients who have a known predisposing factor to cardiac arrhythmia, or who are concomitantly treated with a potentially arrhythmogenic drug. In patients with pre-existing prolonged QT intervals use of alternative treatments is to be considered.
|
|
Updated on 28/02/2006 and displayed until 04/02/2010
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 24/02/2006 and displayed until 28/02/2006
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 24/02/2006 and displayed until 24/02/2006
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
