Parallel Imports Of The Medicinal Product For Human Use «Detralex»

Original Language Title: Importazione parallela del medicinale per uso umano «Detralex»

Read the untranslated law here:

Retrieved February 16, 2015 V&A # 293 IP determines the parallel importation of a medicinal product authorized DETRALEX, 2 500 mg Tabs 30. filmed, compressed Al/PVC blisters from ROMANIA with permission number 4691/2004/01 with the specifications below and provided that they are valid and effective on the date of entry into force of this determination: importer : MPF Pharma S.r.l. Via Clara Maffei, 2B-24121 Bergamo;
Package: DETRALEX «500 mg film-coated tablets» 30 tablets.
AIC code: 19LUXR 043609015 (10) (32).
Dosage form: tablets.
Composition: each tablet contains: active ingredient: micronized purified Fraction flavonoica 500 mg, equivalent to 450 mg Diosmin, hesperidin 50 mg expressed in flavonoids;
Excipients: sodium starch glycolate, microcrystalline cellulose, gelatin, magnesium stearate, talc, glycerin, hydroxypropyl methylcellulose (hypromellose), macrogol 6000, sodium lauryl sulphate, iron oxide yellow and iron oxide red 172 and 172, titanium dioxide E 171.
Medical indications: Symptoms caused by venous insufficiency; States of capillary fragility.
Secondary repackaging authorized secondary packaging at the officine CIT S.r.l., Via Primo Villa 17, 20040 Burago di Molgora (MB); FIEGE Logistics Italy S.p.a.-Via Amendola, 1, 20090 Caleppio di Settala (MI).
Classification for the purposes of new listings ' box: DETRALEX «500 mg film-coated tablets» 30 tablets.
AIC code: 043609015; New listings ' class: c. Classification for the purposes of delivery set: DETRALEX «500 mg film-coated tablets» 30 tablets Code AIC: 043609015; SOP: non-prescription medicines, but not over the counter.
Date of determination: from the day following its publication in the official journal of the Italian Republic.