Summary of Product Characteristics
last updated on the eMC:
15/08/2007
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 15/08/2007 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
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 5.3 - Preclinical Safety Data
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 1, 4.5, 6.6 - changes to heading titles.
Section 4.4: 'dipyridamole' has replaced full product name in penultimate paragraph.
Sectionn 5.3: Added.
|
|
Updated on 26/07/2004 and displayed until 15/08/2007
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 01/07/2003 and displayed until 26/07/2004
|
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 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.9 - Overdose
-
Change to section 6.1 - List of Excipients
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 23/12/2002 and displayed until 01/07/2003
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 11/02/2002 and displayed until 23/12/2002
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments 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
|
|
Updated on 24/07/2001 and displayed until 11/02/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 06/09/1999 and displayed until 24/07/2001
|
Reasons for adding or updating:
|
|
|
|