Authorisation For The Medicinal Product For Usoumano «Misyo».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Misyo».

Read the untranslated law here:

Retrieved March 30, 2015 2015 the resolution No. 348/Medicine: MISYO.
A.I.C. holder: INN-014-1000 Ljubljana Maleševa ulica d.o.o-FARM-Slovenia.
Packaging: «10 mg/ml concentrate for oral solution 1 vial 100 ml-glass» A.I.C. # 042044014 (10), 1832MG (32);
«10 mg/ml concentrate for oral solution 1000 ml glass vial-1» A.I.C. # 042044026 (10), 1832MU (32).
Pharmaceutical form: concentrate for oral solution.
Composition: each ml of concentrate for oral solution contains: active ingredient: 10 mg of methadone hydrochloride;
excipients: sorbitol liquid non-crystallizable (E420), glycerol (e 422), sodium benzoate (E211), citric acid monohydrate (E330), color brilliant blue FCF (E133), purified water.
Production active ingredient: Siegfried Ltd. -Untere Brühlstrasse 4-4800 Zofingen-Switzerland;
Pioneer Agro Industries-Plot # 8, MIDC Industrial Estate, Kulgaon, Badlapur, Thane District, 421 503 Posts Maharashtra-India.
Batch release: Alkaloid-Šlandrova ulica 4, Int d.o.o-1231 Ljubljana-Črnuče-Slovenia.
Batch control: Hameln rds 900 01 Modra-Slovakia a.s.-Horna, 36;
Marifarm, proizvodnja in storitve d.o.o-Minarikova ulica 8, 2000 Maribor-Slovenia;
Marifarm Zavod za zdravstveno varstvo Maribor Prvomajska contract, ulica 1, 2001 Maribor-Slovenia.
Production, primary and secondary packaging: Alkaloid AD-Skopje-blvd. Aleksandar Makedonski 12, 1000 Skopje-Macedonia.
Medical indications: replacement maintenance therapy for opioid dependence in adulthood, together with medical, social and psycho-social assistance.
Classification for the purposes of new listings is the packs referred to in art. 1 are placed, by virtue of art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537, and subsequent amendments, called class C (nn) ".
Classification for the purpose of the classification for the supply of the medicinal product «Misyo» is the following: medicinal product subject to medical prescription, to be used only in hospitals or in similar structure to it (OSP).
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) under art. 107-c, paragraph 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following its publication in the official journal of the Italian Republic.