Linoladiol Estradiol Emulsion
Recall
|
Medicines
|
06/02/2015
The marketing authorization holder has informed its supplied customers that due to Commission Implementing Decision C(2014) 6030 of 19.08.2014 concerning marketing authorizations for medicinal products for human use for topical application with high concentrations of estradiol in accordance with Article 31 of Directive 2001/83/EC, the following changes to "Linoladiol Estradiol - Emulsion" are effective as of 2.2.2015:
- Change in product information
- Reduction of the package size to 25g.
Accordingly, "Linoladiol Estradiol - Emulsion" in the package size 100g may no longer be marketed in Austria as of 2.2.2015 and thus a recall has been initiated.
| Name of the medicinal product | Linoladiol Estradiol – Emulsion(100g) |
|---|---|
| Marketing authorisation number(s) | 1-18868 |
| Marketing authorisation holder | Pharmazeutische Fabrik Montavit Gesm.b.H., 6067 Absam/Tirol |
| Batch number(s) | Alle |
| Classification of the recall | 3 |
| BASG reference number | INS-640.001-1336 |
Further inquiry note
Page last modified:
12/07/2022