Authorisation For The Medicinal Product For Usoumano «Brimonidine Jgl».

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

Read the untranslated law here:

Retrieved March 30, 2015 # 362/2015 of Medicine determines: BRIMONIDINE JGL.
Owner: Jadran Galenski LAboratorij-A.I.C., d.o. or Ljubljana-Ljubljana-Slovenia Litostrojska cesta 46A-1000.
Package: «2 mg/ml eye drops 5 ml-1 LDPE bottle ' by A.I.C. # 043487014 (10), 19H3T6 (32).
Pharmaceutical form: eyedrops, solution.
Composition: 1 ml of solution contains: active ingredient: 2 mg of brimonidine tartrate brimonidine, equivalent to 1.3 mg;
other ingredients: benzalkonium chloride, polyvinyl alcohol, sodium citrate, citric acid monohydrate, sodium chloride, purified water, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
Production of active ingredient: brimonidine tartrate: Indoco Remedies Ltd. (Kilo Lab), R-92/93, Thane Belapur Road, MIDC, TTC, Rabale, Navi Mumbai, India 400 701-(production, control and release lots);
Fdc Limited, Plot No. 19 & 20/2, M.I.D.C. Industrial Area, Village Dhatav, Roha, Dist. Raigad, Maharashtra State, India-402 116 (production, control and release lots).
Production, primary and secondary packaging, inspection lots: Jadran Galenski laboratorij-20, Rijeka, 51000-Svilno d.d., Croatia.
Batch release, microbiological control of lots: Jadran Galenski laboratorij-d.d., Rijeka, 51000-Pulac 4A, Croatia.
Sterilization of the primary container: Synergy Health Däniken AG, Hogenweidstrasse 6, 4658 Däniken,-Switzerland.
Medical indications: «Brimonidine JGL» is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
As monotherapy in patients for whom the topical therapy with beta-blockers is contraindicated.
As adjunctive therapy with other drugs that lower the intraocular pressure when the PIOUS that you want is not attained with a single agent.
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 purposes of the supply of medicine «Brimonidine JGL» is the following: medicinal product subject to medical prescription (RR).
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.