Authorisation For The Medicinal Product For Usoumano «Orvatez».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-23&atto.codiceRedazionale=15A02098&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 4, 2015 V&A # 396/2015 of description determines medicine and assigning AIC is authorised the placing on the market of the medicinal product: ORVATEZ in form and packaging: "10 mg/10 mg film-coated tablets" 10 tablets in AL/AL, "10 mg/10 mg film-coated tablets" 30 tablets in AL/AL, "10 mg/10 mg film-coated tablets" 90 tablets in AL/AL , "10 mg/10 mg film-coated tablets" 100 tablets in AL/AL, "10 mg/10 mg film-coated tablets" 30x1 tablets in single-dose 10 mg/AL/AL, "10 mg film-coated tablets" Automatyczne tablets in single-dose 10 mg/20 mg AL/AL, "tablets" 10 tablets in AL/AL, "10 mg/20 mg film-coated tablets" 30 tablets in AL/AL , "10 mg/20 mg film-coated tablets" 90 tablets in AL/AL, "10 mg/20 mg film-coated tablets" 100 tablets in AL/AL, "10 mg/20 mg film-coated tablets" 30x1 tablets in single-dose 10 mg/20 mg AL/AL, "tablets" AL/AL Automatyczne tablets in single-dose, "10 mg/40 mg film-coated tablets" 10 tablets in AL/AL , "10 mg/40 mg film-coated tablets" 30 tablets in AL/AL, "10 mg/40 mg film-coated tablets" 90 tablets in AL/AL, "10 mg/40 mg film-coated tablets" 100 tablets in AL/AL, "10 mg/40 mg film-coated tablets" 30x1 tablets in single-dose 10 mg/40 mg AL/AL, "tablets" AL/AL Automatyczne tablets in unit dose , "10 mg/80 mg film-coated tablets" 10 tablets in AL/AL, "10 mg/80 mg film-coated tablets" 30 tablets in AL/AL, "10 mg/80 mg film-coated tablets" 90 tablets in AL/AL, "10 mg/80 mg film-coated tablets" 100 tablets in AL/AL, "10 mg/80 mg film-coated tablets" 30x1 tablets in AL/AL-dose , "10 mg/80 mg film-coated tablets" Automatyczne tablets in AL/AL, under the conditions and with the specifications mentioned below: Mah: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon Hertfordshire EN11 9BU, United Kingdom packaging: "10 mg/10 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249010 (10) 197VCL (based on 32) packaging: "10 mg/10 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249022 (10) 197VCY (in Base 32) packaging: "10 mg/10 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249034 (10) 197VDB (based on 32) packaging: "10 mg/10 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249135 (10) 197VHH (based on 32) packaging: "10 mg/10 mg film-coated tablets" 30x1 tablets in AL/AL-dose AIC # 043249174 (10) 197VJQ (32) : "10 mg/10 mg film-coated tablets" Automatyczne tablets in AL/AL-dose AIC # 043249212 (10) 197VKW (based on 32) dosage form: film-coated tablet validity complete appliance: 2 years from date of manufacture special precautions for storage: store in the original package to protect from oxygen composition: each film-coated tablet contains: active ingredient : 10 mg of ezetimibe 10 mg and atorvastatin (as atorvastatin calcium trihydrate) other ingredients: Tablet core Layer of granulated ezetimibe: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate;
Layer of granulated Atorvastatin: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, polysorbate 80, calcium carbonate, magnesium stearate, colloidal anhydrous silica coating Film hypromellose, macrogol 8000, titanium dioxide (E171), talc;
Packaging: "10 mg/20 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249046 (10) 197VDO (based on 32) packaging: "10 mg/20 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249059 (10) 197VF3 (based on 32) packaging: "10 mg/20 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249061 (10) 197VF5 (32) : "10 mg/20 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249147 (10) 197VHV (based on 32) packaging: "10 mg/20 mg film-coated tablets" 30x1 tablets in AL/AL-dose AIC # 043249186 (10) 197VK2 (based on 32) packaging: "10 mg/20 mg film-coated tablets" Automatyczne tablets in AL/AL-dose AIC # 043249224 (10) 197VL8 (based on 32) pharmaceutical form : film-coated tablet validity complete appliance: 2 years from date of manufacture special precautions for storage: store in the original package to protect from oxygen composition: each film-coated tablet contains: active ingredient: 10 mg of ezetimibe and 20 mg atorvastatin (as atorvastatin calcium trihydrate) other ingredients: Tablet core Layer of granulated ezetimibe: croscarmellose sodium, lactose monohydrate , magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate;
Layer of granulated Atorvastatin: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, polysorbate 80, calcium carbonate, magnesium stearate, colloidal anhydrous silica coating Film hypromellose, macrogol 8000, titanium dioxide (E171), talc;
Packaging: "10 mg/40 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249073 (10) 197VFK (based on 32) packaging: "10 mg/40 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249085 (10) 197VFX (based on 32) packaging: "10 mg/40 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249097 (10) 197VGP (32) : "10 mg/40 mg film-coated tablets" 100 tablets in AL/AL AIC # 04324150 (10) 197VHY (based on 32) packaging: "10 mg/40 mg film-coated tablets" 30x1 tablets in AL/AL-dose AIC # 04324198 (10) 197VKG (based on 32) packaging: "10 mg/40 mg film-coated tablets" Automatyczne tablets in AL/AL-dose AIC # 04324236 (10) 197VLN (based on 32) pharmaceutical form : film-coated tablet validity complete appliance: 2 years from date of manufacture special precautions for storage: store in the original package to protect from oxygen composition: each film-coated tablet contains:

Active ingredient: 10 mg of ezetimibe and 40 mg atorvastatin (as atorvastatin calcium trihydrate) other ingredients: Tablet core Layer of granulated ezetimibe: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate;
Layer of granulated Atorvastatin: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, polysorbate 80, calcium carbonate, magnesium stearate, colloidal anhydrous silica coating Film hypromellose, macrogol 8000, titanium dioxide (E171), talc;
Packaging: "10 mg/80 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249109 (10) 197VGP (based on 32) packaging: "10 mg/80 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249111 (10) 197VGR (based on 32) packaging: "10 mg/80 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249123 (10) 197VH3 (32) : "10 mg/80 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249162 (10) 197VJB (based on 32) packaging: "10 mg/80 mg film-coated tablets" 30x1 tablets in AL/AL-dose AIC # 043249200 (10) 197VKJ (based on 32) packaging: "10 mg/80 mg film-coated tablets" Automatyczne tablets in AL/AL-dose AIC # 043249248 (10) 197VM0 (based on 32) pharmaceutical form : film-coated tablet validity complete appliance: 2 years from date of manufacture special precautions for storage: store in the original package to protect from oxygen composition: each film-coated tablet contains: active ingredient: 10 mg of ezetimibe and 80 mg atorvastatin (as atorvastatin calcium trihydrate) other ingredients: Tablet core Layer of granulated ezetimibe: croscarmellose sodium, lactose monohydrate , magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate;
Layer of granulated Atorvastatin: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, croscarmellose sodium, polysorbate 80, calcium carbonate, magnesium stearate, colloidal anhydrous silica coating Film hypromellose, macrogol 8000, titanium dioxide (E171), talc;
Manufacturer of the active substance: MSD International GmbH (Singapore Branch), 638408 50 Tuas West Drive Singapore, (ezetimibe);
Dr Reddy's Laboratories Limited, Chemical Technical Operations – 2, Plot No. 110 111 502 325 Sri Venkateswara, Co-operative & Industrial Estate, Bolarum, Jinnaram, Medak District, Andhra Pradesh, India (atorvastatin calcium trihydrate) manufacturer of the finished product: MSD International GmbH (Singapore Branch), 638414 70 Tuas West Drive, Singapore (production);
MSD International GmbH (Puerto Rico Branch) LLC, State Road 183, PRIDCO Industrial Park, Las Piedras, Puerto Rico, United States of America 00771 (production);
Merck Sharp & Dohme BV, Haarlem, Netherlands Waarderweg 39 BN, 2031 (primary and secondary packaging, quality control and batch release);
Medical indications: high cholesterol ORVATEZ is indicated as adjunctive therapy to diet in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or with mixed Hyperlipidemia which indicated the use of a product by Association--patients inadequately controlled with a Statin monotherapy-patients already treated with a Statin and ezetimibe.
ORVATEZ contains ezetimibe and atorvastatin. It has been shown that atorvastatin reduces the frequency of cardiovascular events (see section 5.1). It's not evidence of a beneficial effect of ORVATEZ or ezetimibe on morbilita and cardiovascular mortality.
Homozygous Familial Hypercholesterolemia (IF homozygous) ORVATEZ is indicated as adjunctive therapy to diet in adults with IF homozygous. Patients may also be subjected to additional therapeutic measures (eg. low density lipoprotein Apheresis [LDL]).
New listings for the purposes of classification is packaging: "10 mg/10 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249010 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/10 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249022 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/10 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249034 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/10 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249135 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/10 mg film-coated tablets" 30x1 tablets in AL/AL 043249174 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/10 mg film-coated tablets" Automatyczne tablets in AL/AL 043249212 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/20 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249046 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).

Packaging: "10 mg/20 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249059 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/20 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249061 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/20 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249147 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/20 mg film-coated tablets" 30x1 tablets in AL/AL 043249186 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/20 mg film-coated tablets" Automatyczne tablets in AL/AL 043249224 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249073 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249085 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249097 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" 100 tablets in AL/AL AIC # 04324150 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" 30x1 tablets in AL/AL 04324198 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/40 mg film-coated tablets" Automatyczne tablets in AL/AL 04324236 new listings ' class-dose AIC no: section of the class referred to in art. 8, subparagraph 10 (c)) of law No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249109 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249111 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249123 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249162 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" 30x1 tablets in AL/AL 043249200 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: "10 mg/80 mg film-coated tablets" Automatyczne tablets in AL/AL 043249248 new listings ' class-dose AIC no: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purposes of delivery set: "10 mg/10 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249010-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/10 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249022-RR: medicinal product subject to medical prescription.

Packaging: "10 mg/10 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249034-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/10 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249135-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/10 mg film-coated tablets" 30x1 tablets in AL/AL 043249174-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/10 mg film-coated tablets" Automatyczne tablets in AL/AL 043249212-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249046-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249059-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249061-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249147-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" 30x1 tablets in AL/AL 043249186-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/20 mg film-coated tablets" Automatyczne tablets in AL/AL 043249224-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249073-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249085-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249097-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" 100 tablets in AL/AL AIC # 04324150-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" 30x1 tablets in AL/AL 04324198-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/40 mg film-coated tablets" Automatyczne tablets in AL/AL 04324236-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" 10 tablets in AL/AL AIC # 043249109-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" 30 tablets in AL/AL AIC # 043249111-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" 90 tablets in AL/AL AIC # 043249123-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" 100 tablets in AL/AL AIC # 043249162-RR: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" 30x1 tablets in AL/AL 043249200-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging: "10 mg/80 mg film-coated tablets" Automatyczne tablets in AL/AL 043249248-RR-dose AIC no: medicinal product subject to medical prescription.
Packaging of printed material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Periodic safety update reports PSUR-marketing authorisation holder shall submit the first periodic safety update report for this medicine within 3 years following authorisation. Subsequently, the marketing authorisation holder will present the 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 c, para. 7 of Directive 2010/84/EC and published on medicines web-portal.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.