Authorisation For The Medicinal Product For Usoumano «Linezolid Sandoz».

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

Read the untranslated law here:

Retrieved December 18, 2014 2014 # 1556/determines the medicinal product: LINEZOLID SANDOZ.
A.I.C. owner: Sandoz S.p.a., Largo U. Boccioni n. 1, 21040 Origgio (VA).
Packaging: «600 mg film-coated tablets» 10 tablets in OPA/AL/PVC/AL-A.I.C. # 043491012 (10) 19H7Q4 (based on 32);
«600 mg film-coated tablets» 10X1 tablets in OPA/AL/PVC/AL-A.I.C. # 043491024 (10) 19H7QJ (based on 32);
«600 mg film-coated tablets» 30 tablets in OPA/AL/PVC/AL-A.I. C # 043491036 (10) 19H7QW (based on 32).
Pharmaceutical form: film-coated tablet.
Composition: each film-coated tablet contains: active ingredient: 600 mg linezolid.
Ingredients: other ingredients (Tablet core): microcrystalline cellulose;
Colloidal silicon dioxide;
Corn starch glycolate type A;
Hydroxypropyl cellulose;
Magnesium Stearate.
Other ingredients (film): Hypromellose (E464);
Titanium dioxide (E 171);
Macrogol (E1521).
Production active ingredient: Symed Laboratories Limited (Unit-II), Plot-25/B, Phase-III, I.D. to Jeedimetla, Hyderabad, Andhra Pradesh, India.
Production, primary and secondary packaging, quality control and batch release: S.C. Sandoz, S.r.l.
Livezeni str. nr. 7A, RO-540,472 Targu-Mures, Romania.
Batch release: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

Papan kekunci družba d.d., LEK (Lek Pharmaceuticals d.d.)
Verovškova 57, 1526 Ljubljana, Slovenia.
Primary and secondary packaging: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany.

Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen Germany.

Papan kekunci družba d.d., LEK (Lek Pharmaceuticals d.d.)
Verovškova 57, 1526 Ljubljana Slovenia.

LEK papan kekunci družba d.d.
(Lek Pharmaceuticals d.d.)
Trimlini 9220 Lendava, Slovenia 2D.
Outer carton: UPS Healthcare Italy S.r.l.
00060 Formello 4.300 Kilometers away, Greely, Italy.
Medical indications: nosocomial pneumonia;
Community-acquired pneumonia.
Linezolid Sandoz is indicated for the treatment of nosocomial pneumonia and community-acquired pneumonia when you suspect or know that they are caused by susceptible Gram positive bacteria. You must take into consideration the results of microbiological tests or information on the prevalence of bacterial resistance of Gram-positives to determine the appropriateness of treatment with Linezolid Sandoz (see section 5.1 for the appropriate bodies).
Linezolid is not in service in infections caused by Gram negative bacteria. In the event that it is established or suspected the presence of Gram negative bacteria, must be simultaneously launched a specific therapy for these microorganisms.
Complicated skin and soft tissue (see section 4.4).
Linezolid Sandoz is indicated for the treatment of complicated skin and soft tissue infections only when the microbiological testing has determined that the infection caused by susceptible Gram positive bacteria.
Linezolid is not in service in infections caused by Gram negative bacteria. Linezolid should be used in patients with complicated skin and soft tissue, when you suspect or know that are caused by infection with Gram-negatives, only when there are no other therapeutic alternatives (see section 4.4). Under these circumstances must be simultaneously started a treatment against Gram negative bacteria.
Treatment with linezolid should be initiated only in a hospital environment and after consultation with a qualified specialist as a microbiologist or infectious disease specialist.
Need to be considered official guidance on the proper use of antibacterial agents.
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 as amended, called class C (nn).
Classification for the purpose of the classification for the purposes of providing the medicine LINEZOLID SANDOZ is the following: medicinal product subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialists: internist, infectious disease specialist, hematologist (RNRL).
The holder of the patent protection A.I.C. the generic drug is exclusively responsible for the full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The holder of the A.I.C. generic drugs and is also responsible for full compliance with the provisions of art. 14 paragraph 2 of Legislative Decree No 219/2006 imposing certain not to include printed matter those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of the medicinal product.
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-The marketing authorisation holder shall provide periodic safety update reports for this product in accordance with the requirements set out in the list of dates of reference (EURD list) referred to in article 107-quater, para. 2010/84/EC Directive 7) and published on the web portal of the European Medicines Agency.
Final provisions this determination takes effect on the day following its publication in the official journal of the Italian Republic, and will be notified to the company marketing authorisation holder.