Summary of Product Characteristics
last updated on the eMC:
15/11/2010
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 15/11/2010 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: 05-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.6 of Pregnancy and Lactation was updated with foll information:
Pregnancy:
Ferrous sulphate tablets can be used during pregnancy if clinically indicated.
Lactation:
No adverse effects of ferrous sulphate have been shown in breastfed infants of treated mothers. Ferrous sulphate tablets can be used during breast-feeding if clinically indicated.
|
|
Updated on 27/09/2010 and displayed until 15/11/2010
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 22-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| There has been a change in the product name of the medicinal product from:
"Ferrous Sulphate Tablets 200mg" to "Ferrous sulphate 200mg Tablets" in order to comply with the new legislation.
|
|
Updated on 01/04/2010 and displayed until 27/09/2010
|
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 |
|
