Summary of Product Characteristics
last updated on the eMC:
18/01/2011
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 18/01/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 13-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.6: This section has been updated and the following has been added:
Pregnancy
Ferrous fumarate can be used during pregnancy if clinically indicated.
Lactation
No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous fumarate can be used during breast-feeding if clinically indicated.
|
|
Updated on 25/11/2010 and displayed until 18/01/2011
|
Reasons for adding or updating:
|
-
Change of Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 04-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| MA holder name was changed from "Goldshield Group PLC” to "Goldshield Group Limited”.
|
|
Updated on 31/03/2010 and displayed until 25/11/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
