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:

  1. Change in product information
  2. 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 recall3
BASG reference number INS-640.001-1336

Further inquiry note