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Mieszkowski Medical Associates News:

Date	Detail
19 Jan 2006	IBSS Biomed, a Polish company based in Krakow, Poland have been appointed as the Distributor for the Anapen™ devices in Poland. The introduction of both presentations of Anapen™ and Anapen™ Junior will take place in March 2006. Both presentations of product are already available at Biomed in Polish livery and in Polish packaging and with Polish language patient instructions. Anapen™ Junior will be the only low dose auto-injector device registered and approved in Poland for use in children with a body weight from 15kg. Anapen™ is licensed for the reversal of life threatening anaphylactic reactions caused for any reason.
18 Jan 2006	MMA are delighted to announce the appointment of Ewopharma AG of Schaffhausen, Switzerland and their respective in-country subsidiaries in the Czech Republic, Slovakia, Croatia and Bulgaria as the official Distributors for the Anapen™ devices. Commercial launch in the Czech Republic will take place in quarter 1 of 2006. The national registration process in Bulgaria and in Croatia will start shortly, Slovakia will be included in a further round of MR processes later this quarter.
1 Dec 2004	Official confirmation was given today by the Ministerul Sanatatii, Agentia Nationala a Medicamentului in Bucharest, Romania, that they have granted a marketing authorisation for Anapen® and Anapen®Junior with effect from the 29th of November 2004. This approval was granted on the basis of a national licensing submission and was concluded and approved in record time. Both product presentations will be launched in March 2005 by Halcis SRL of Timisoara as the distributor.
26 Nov 2004	MMA are delighted to announce that the Hungarian Ministry of Health have issued the marketing authorisations for Anapen® and Anapen® Junior with effect from to-day’s date. Reimbursement discussions have now been started and product launches are scheduled for early 2005 by the distributor, Medinspect Kft
25 Oct 2004	Registration of ANAPEN™ will commence very shortly in Croatia under the National Approval process as the dossiers are updated following regulatory approvals granted on the 18th of October 2004 in the following countries, Austria, Portugal, Greece, Netherlands, Luxemburg, Cyprus, Poland, Hungary and the Czech Republic. The UK MHRA based in London did a very effective and hugely professional job in managing the process successfully. A third round of registrations of ANAPEN™ will commence shortly in Slovenia, Latvia, Lithuania and Estonia in addition to Belgium, Spain, Italy and Denmark. Distributors are also actively being sought for certain other key countries including Russia and Turkey
22 Oct 2004	MMA are pleased to announce that ANAPEN™ has been approved through the Mutual Recognition process driven very effectively by the MHRA in London, UK, in the following countries, Poland, Hungary and the Czech Republic.
13 May 2004	MMA are delighted to announce that Salisbury Medical, the trading arm of MMA have appointed S.C. Diagnostic Terapie Halcis Alergie S.R.L. of Timisoara, Romania as the exclusive Distributor of ANAPEN for that country.A national registration process has been commenced with effect from today's date, 13th of May, 2004 and it is expected that registration will be completed by October 2004. Commercial launch of the ANAPEN products will take place at the National Allergy and Immunology Congress scheduled for that month. Halcis Romania are a leading locally owned company established in 1984 specialising in the field of desensitisation immunotherapy and associated allergy areas. ANAPEN is indicated for the treatment of anaphylaxis and is prescription only medication fully available in the UK, France, Germany, Ireland and Sweden and in registration in a number of European countries.
09 Mar 2004	Salisbury Medical the trading arm of MMA announce the appointment of Medinspect Kft of Fot,Hungary, as the exclusive Distributor of ANAPEN™ for that country. Registration will be via the EU Mutual Recognition process and will start in May 2004 with a 90 day time line to approval. Medinspect Kft are a leading Hungarian owned company working in the area of allergy and immunology and represent a number of companies with specialist radiochemicals and associated items.
5 Dec 2003	MMA announce that their associate company Salisbury Medical Ltd has been granted the agency rights for ANAPEN™ for the emerging countries of Central East Europe which will become full EU Members in May 2004. ANAPEN™ is an autoinjector containing adrenaline and is indicated for the treatment of anaphylaxis in patients who are known to be at risk from this life threatening reaction. ANAPEN™ is registered already as prescription only medication in a number of European countries including the UK, France, Germany, Ireland and Sweden and is going through the mutual recognition process in other EU countries.
12 Nov 2002	Mieszkowski Medical Associates Limited establishes internet presence.