Summary of Product Characteristics
last updated on the eMC:
13/03/2008
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 13/03/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 03/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7. The name of the MAH has changed. Addition of P.O.Box to the address line.
|
|
Updated on 18/04/2006 and displayed until 13/03/2008
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.1 - Therapeutic Indications
-
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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 11/04/2006 and displayed until 18/04/2006
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.1 - Therapeutic Indications
-
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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 01/03/2005 and displayed until 11/04/2006
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6.1 - List of Excipients
|
|
Updated on 21/10/2002 and displayed until 01/03/2005
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 17/09/2002 and displayed until 21/10/2002
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 10/09/2002 and displayed until 17/09/2002
|
Reasons for adding or updating:
|
|
|
|