This is the first marketing approval for Volplex, and it will be used as the basis for approval in the rest of the European Union through the mutual recognition procedure
. EU sales of blood plasma replacement products are currently valued at around pounds 53m.
Earlier this year, Emergent completed the mutual recognition procedure
for BioThrax expanding licensure of BioThrax in five European countries, namely, the U.K., Poland, France, Italy and the Netherlands, in addition to Germany, where BioThrax received market authorization in 2013.
Glucophage IR is approved by a Mutual Recognition Procedure
, where France acted as the Reference Member State.
A mutual recognition procedure
that allows for easier launch of a product marketed in one EU country into another does exist, but it still requires a lengthy period of evaluation (90 days or more), and even a risk of eventual rejection of the marketing authorization application if the product in question is considered unsafe.
Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with RHB-103, RedHill and IntelGenx plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure
Under its registration strategy, the company had filed in these countries first to ensure optimised registration timelines and then filed a mutual recognition procedure
in France and Germany, which are two major European countries with the greatest commercial potential in the European herpes labialis market.
The Swedish company will carry out a mutual recognition procedure
in the forthcoming months to secure marketing authorisation in the majority of the above mentioned countries.
The company says myfortic successfully completed the European Mutual Recognition Procedure
(MRP) and was approved for the prevention of acute rejection of kidney allografts in adult patients on February 7, 2004.
Emergent BioSolutions completed the Mutual Recognition Procedure
for market authorization of BioThrax in five Concerned Member States within the European Union, including Italy, the Netherlands, Poland, the U.K., and France.
M2 PHARMA-October 22, 2013-i" GW Pharmaceuticals completes European Mutual Recognition Procedure
for Sativex oromucosal in France(C)2013 M2 COMMUNICATIONS
One daily intake of Seroquel XR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) has been approved under the European Mutual Recognition Procedure
for the stated indications in patients whose manic, mixed or depressive episode has responded to quetiapine treatment, AstraZeneca said in a statement.
UCB, Brussels, Belgium, has successfully completed the European Mutual Recognition Procedure
(MRP) for Equasym(TM) XL for use in the treatment of the symptoms of attention deficit hyperactivity disorder (ADHD) with the UK acting as the Reference Member State for the MRP.