09 February 2017 EMA/106582/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): midodrine Procedure No.: PSUSA/00003178/201606

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product full name (in authorisation country)

MRP/DCP or CP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

GUTRON GUTRON GUTRON GUTRON GUTRON GUTRON GUTRON GUTRON GUTRON GUTRON 1 % - Tropfen GUTRON 2,5 mg - Tabletten GUTRON 2,5 mg comprimate GUTRON 2,5 mg comprimate GUTRON 2,5 mg comprimate Gutron 2,5 mg tabletta Gutron 2,5 mg tabletta GUTRON 2,5 mg, comprimé GUTRON 2,5 mg, comprimé GUTRON 2,5 mg, comprimé GUTRON 2,5 mg, comprimé GUTRON 2,5 mg, tablety GUTRON 5 mg - Tabletten GUTRON 5 mg comprimidos, 5mg GUTRON 5 mg, tablety Gutron 5, tabletten 5 mg Gutron® Tabletten 2,5 mg Gutron® Tropfen 1 % Midon 2.5 mg Tablets Midon 5 mg Tablets Гутрон 2,5 mg таблетки Гутрон 5 mg таблетки

not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available not available NL/H/0247/002 not available NL/H/0247/002 not available not available not available not available not available not available

024519035 024519023 024519011 024519035 024519023 024519011 024519035 024519023 024519011 15.448 15.447 7023/2014/02 7023/2014/03 7023/2014/01 OGYI-T-4239/01 OGYI-T-4239/02 34009 348 254 8 4 34009 348 255 4 5 34009 348 252 5 5 34009 348 253 1 6 78 / 826 / 92 – A/C 15.434 65.058 78 / 826 / 92 – B/C RVG 16514 6428206.00.00 6428206.00.01 PA 1547/6/1 PA 1547/6/2 II-2794 II-2795

ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA FRANCE S.A.S. TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH TAKEDA FARMACÉUTICA ESPAÑA S.A TAKEDA AUSTRIA GMBH TAKEDA NEDERLAND BV TAKEDA GMBH (KONSTANZ) TAKEDA GMBH (KONSTANZ) TAKEDA UK LTD TAKEDA UK LTD TAKEDA AUSTRIA GMBH TAKEDA AUSTRIA GMBH

IT IT IT IT IT IT IT IT IT AT AT RO RO RO HU HU FR FR FR FR CZ AT ES CZ NL DE DE IE IE BG BG

List of nationally authorised medicinal products EMA/106582/2017

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