Summary of Product Characteristics
last updated on the eMC:
20/01/2011
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 20/01/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Addition of Black Triangle
|
| Date of revision of text on the SPC: 19-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| 1. NAME OF THE MEDICINAL PRODUCT
Nivestim ▼30 MU/ 0.5 ml solution for injection/infusion.
|
|
Updated on 30/11/2010 and displayed until 20/01/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 19-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| 6.4 Special precautions for storage
CHANGE FROM 48 HOURS TO 7 DAYS
Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 7 days. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
10. DATE OF REVISION OF THE TEXT
DATE CHANGE
19/11/2010
|
|
Updated on 05/11/2010 and displayed until 30/11/2010
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 19-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| 6.3 Shelf life
SHELF LIFE CHANGE FROM 2 YEARS TO 30 MONTHS
30 months.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/06/2010 DATE CHANGE FROM 9TH TO 8TH
10. DATE OF REVISION OF THE TEXT
DATE CHANGE
19/10/2010
|
|
Updated on 24/06/2010 and displayed until 05/11/2010
|
Reasons for adding or updating:
|
|
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
