Summary of Product Characteristics
last updated on the eMC:
23/08/2011
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 23/08/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
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 4.3 - 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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
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: 28-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| These changes are due to an extensive CCDS update to bring the SmPC in line with the EU Core SmPC.
|
|
Updated on 28/09/2007 and displayed until 23/08/2011
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7: Company name change from ZLB Behring to CSL Behring
|
|
Updated on 19/07/2006 and displayed until 28/09/2007
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 8 - MA number
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 2 - included concentration of 750IU (150 mcg)
Section 4.4 - revised Information on safety with respect to transmissible agents
Section 8 - Included new PL nubmer PL15036/0019
Section 9 - Renewal of product licence, hence renewal date changed
Section 10 - Text revision date updated
|
|
Updated on 19/12/2003 and displayed until 19/07/2006
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
|
Updated on 03/10/2003 and displayed until 19/12/2003
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 23/04/2003 and displayed until 03/10/2003
|
Reasons for adding or updating:
|
|
|
|
