Authorisation For The Medicinal Product For Levodopa/carbidopa/entecapone Usoumano «Teva».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Levodopa/Carbidopa/Entecapone Teva».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10119&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the December 16, 2014 1498/2014 # Medicine: LEVODOPA/CARBIDOPA/ENTECAPONE TEVA Mah: Teva Italy S.r.l., Via Messina 38-20154 Milano.
Package «50 mg/200 mg/12.5 mg film-coated tablets» 10 tablets in HDPE-AIC # 043128014 (10) 19456G (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 28 tablets in HDPE-AIC # 043128026 (10) 19456U (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 30 tablets in HDPE-AIC # 043128038 (10) 194576 (based on 32) «50 Pack mg/200 mg/12.5 mg film-coated tablets» 50 tablets in HDPE-AIC # 043128040 (10) 194578 (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 60 tablets in HDPE-AIC # 043128053 (10) 19457P (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 90 tablets in HDPE-AIC # 043128065 (10) 194581 (based on 32) «50 mg/12.5 mg/200 mg film-coated tablets» 98 tablets in HDPE-AIC # 043128077 (10) 19458F (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 100 tablets in HDPE-AIC # 043128089 (10) 19458T (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 130 tablets in HDPE-AIC # 043128091 (10) 19458V (based on 32) 50 mg/12.5 mg/200 "Pack mg film-coated tablets» 150 tablets in HDPE-AIC # 043128103 (10) 194597 (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 175 tablets in HDPE-AIC # 043128115 (10) 19459M (based on 32) 50 mg/12.5 mg/Pack ' 200 mg film-coated tablets» 200 tablets in HDPE-AIC # 043128127 (10) 19459Z (based on 32) 50 mg/12.5 mg/200 Pack «mg tablets » 250 film-coated tablets in HDPE-AIC # 043128139 (10) 1945BC (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 10 tablets in HDPE-AIC # 043128154 (10) 1945BU (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 28 tablets in HDPE-AIC # 043128166 (10) 1945C6 (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets movies» 30 tablets in HDPE-AIC # 043128178 (10) 1945CL (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 50 tablets in HDPE-AIC # 043128180 (10) 1945CN (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 60 tablets in HDPE-AIC # 043128192 (10) 1945D0 (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets "90 tablets in HDPE-AIC # 043128204 (10) 1945DD (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 98 tablets in HDPE-AIC # 043128216 (10) 1945DS (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 100 tablets in HDPE-AIC # 043128228 (10) 1945F4 (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 130 tablets in HDPE-AIC # 043128230 (10) 1945F6 (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 150 tablets in HDPE-AIC # 043128242 (10) 1945FL (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 175 tablets in HDPE-AIC # 043128255 (10) 1945FZ (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 200 tablets in HDPE- AIC # 043128267 (10) 1945GC (based on 32) 18.75 mg/75 mg/Pack ' 200 mg film-coated tablets» 250 tablets in HDPE-AIC # 043128279 (10) 1945GR (based on 32) 100 mg/25 mg/200 mg «tablets» 10 tablets in HDPE-AIC # 043128281 (10) 1945GT (based on 32) 100 mg/25 mg/200 mg «tablets» 28 tablets in HDPE-AIC # 043128293 (10) 1945H5 (based on 32) 100 mg/25 mg/200 mg «tablets» 30 tablets in HDPE-AIC # 043128305 (10) 1945HK (based on 32) 100 mg/25 mg/200 mg «tablets» 50 tablets in HDPE-AIC # 043128317 (10) 1945HX (based on 32) 100 mg/25 mg/200 Pack «mg film-coated tablets "60 tablets in HDPE-AIC # 043128329 (in base 10) 1945J9 (based on 32) 100 mg/25 mg/200 mg «tablets» 90 tablets in HDPE-AIC # 043128331 (10) 1945JC (based on 32) 100 mg/25 mg/200 mg «tablets» 98 tablets in HDPE-AIC # 043128343 (10) 1945JR (based on 32) 100 mg/25 mg/200 mg «tablets» 100 tablets in HDPE-AIC # 043128356 (10) 1945K4 (32) 100 mg/25 mg/200 mg «tablets» 130 tablets in HDPE-AIC # 043128368 (10) 1945KJ (based on 32) 100 mg/25 mg/200 mg «tablets» 150 tablets in HDPE-AIC # 043128370 (10) 1945KL (based on 32) 100 mg/25 mg/200 mg «tablets» 175 tablets in HDPE-AIC # 043128382 (10) 1945KY (in Base 32) 100 mg/25 mg/200 Pack «mg film-coated tablets» 200 tablets in HDPE-AIC # 043128394 (10) 1945LB (based on 32) 100 mg/25 mg/200 mg «tablets» 250 tablets in HDPE-AIC # 043128406 (10) 1945LQ (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 10 tablets in HDPE-AIC # 043128418 (10) 1945M2 (32)
Package «31.25 mg/125 mg/200 mg film-coated tablets» 28 tablets in HDPE-AIC # 043128420 (10) 1945M4 (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 30 tablets in HDPE-AIC # 043128432 (10) 1945MJ (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 50 tablets in HDPE-AIC # 043128444 (10) 1945MW (32)

«125 mg/31.25 mg/200 mg film-coated tablets» 60 tablets in HDPE-AIC # 043128457 (10) 1945N9 (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 90 tablets in HDPE-AIC # 043128469 (10) 1945NP (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 98 tablets in HDPE-AIC # 043128471 (10) 1945NR (based on 32) Packaging «125 mg/ 31.25 mg/200 mg film-coated tablets» 100 tablets in HDPE-AIC # 043128483 (10) 1945P3 (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 130 tablets in HDPE-AIC # 043128495 (10) 1945PH (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 150 tablets in HDPE-AIC # 043128507 (10) 1945PV (based on 32) Packaging «31.25 mg/125 mg/ 200 mg film-coated tablets» 175 tablets in HDPE-AIC # 043128519 (10) 1945Q7 (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 200 tablets in HDPE-AIC # 043128521 (10) 1945Q9 (based on 32) Packaging «125 mg/31.25 mg/200 mg film-coated tablets» 250 tablets in HDPE-AIC # 043128533 (10) 1945QP (based on 32) 150 mg/200 mg «37.5 mg/ film-coated tablets» 10 tablets in HDPE-AIC # 043128545 (10) 1945R1 (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 28 tablets in HDPE-AIC # 043128558 (10) 1945RG (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 30 tablets in HDPE-AIC # 043128560 (10) 1945RJ (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets with movies» 50 tablets in HDPE-AIC # 043128572 (10) 1945RW (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 60 tablets in HDPE-AIC # 043128584 (10) 1945S8 (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 90 tablets in HDPE-AIC # 043128596 (10) 1945SN (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 98 tablets in HDPE-AIC # 043128608 (10) 1945T0 (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 100 tablets in HDPE-AIC # 043128610 (10) 1945T2 (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 130 tablets in HDPE-AIC # 043128622 (10) 1945TG (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 150 tablets in HDPE-AIC # 043128634 (10) 1945TU (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 175 tablets in HDPE-AIC # 043128646 (10) 1945U6 (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 200 tablets in HDPE-AIC # 043128659 (10) 1945UM (based on 32) 37.5 mg/150 mg/200 Pack «mg film-coated tablets» 250 tablets in a bottle HDPE-AIC # 043128661 (10) 1945UP (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 10 tablets in HDPE-AIC # 043128673 (10) 1945V1 (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 28 tablets in HDPE-AIC # 043128685 (10) 1945VF (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 30 tablets in HDPE-AIC # 043128697 (10) 1945VT (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 50 tablets in HDPE-AIC # 043128709 (10) 1945W5 (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 60 tablets in HDPE-AIC # 043128711 (10) 1945W7 (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 90 tablets in HDPE-AIC # 043128723 ( in base 10) 1945WM (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 98 tablets in HDPE-AIC # 043128735 (10) 1945WZ (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 100 tablets in HDPE-AIC # 043128747 (10) 1945XC (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 130 tablets in HDPE-AIC # 043128750 (based on 10) 1945XG (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 150 tablets in HDPE-AIC # 043128762 (10) 1945XU (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 175 tablets in HDPE-AIC # 043128774 (10) 1945Y6 (based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 200 tablets in HDPE-AIC # 043128786 (10) 1945YL ( based on 32) Packaging «175 mg/43.75 mg/200 mg film-coated tablets» 250 tablets in HDPE-AIC # 043128798 (10) 1945YY (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 10 tablets in HDPE-AIC # 043128800 (10) 1945Z0 (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 28 tablets in HDPE-AIC # 043128812 (10) 1945ZD (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 30 tablets in HDPE-AIC # 043128824 (10) 1945ZS (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 50 tablets in HDPE-AIC # 043128836 (10) 194604 (32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 60 tablets in HDPE-AIC # 043128848 (10) 19460J (based on 32) box " 200 mg/50 mg/200 mg film-coated tablets» 90 tablets in HDPE-AIC # 043128851 (10) 19460M (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 98 tablets in HDPE-AIC # 043128863 (10) 19460Z (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 100 tablets in HDPE-AIC # 043128875 (10) 19461C (based on 32) Packaging «200 mg/ 50 mg/200 mg film-coated tablets» 130 tablets in HDPE-AIC # 043128887 (10) 19461R (32)

«200 mg/50 mg/200 mg film-coated tablets» 150 tablets in HDPE-AIC # 043128899 (10) 194623 (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 175 tablets in HDPE-AIC # 043128901 (10) 194625 (based on 32) 50 mg/200 mg/Pack ' 200 mg film-coated tablets» 200 tablets in HDPE-AIC # 043128913 (10) 19462K (based on 32) Packaging «200 mg/ 50 mg/200 mg film-coated tablets» 250 tablets in HDPE-AIC # 043128925 (10) 19462X (based on 32) dosage form: film-coated tablet composition: active ingredient: each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 50 mg/12.5 mg/200 mg tablet contains 50 mg levodopa, carbidopa and entacapone 200 mg 12.5 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200 mg tablet contains 75 mg/18.75 mg/75 mg of levodopa , 18.75 mg of carbidopa and entacapone 200 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE 200 mg/25 mg/100 mg TEVA contains 100 mg of levodopa, 25 mg of carbidopa and entacapone 200 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200 mg tablet contains 125 mg/31.25 mg/125 mg of levodopa, carbidopa and entacapone 200 mg 31.25 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200 mg tablet contains 150 mg/37.5 mg/150 mg levodopa, 37.5 mg of carbidopa and entacapone 200 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200 mg tablet contains 175 175 mg/43.75 mg/mg levodopa, carbidopa and entacapone 200 mg 43.75 mg each tablet of LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 200 mg/50 mg/200 mg contains 200 mg of levodopa, 50 mg of carbidopa and entacapone 200 mg Excipients : Tablet core: Lactose anhydrous, microcrystalline cellulose low-substituted Hydroxypropylcellulose Povidone (K-30) colloidal anhydrous magnesium stearate Film-coating: 50 mg/12.5 mg/200 mg: titanium dioxide (E171) Hypromellose glycerol (e 422) iron oxide (E172) Polysorbate 80 red iron oxide (E172) iron oxide (E172) 18.75 mg/75 mg magnesium stearate/200 mg: titanium dioxide (E171) Hypromellose glycerol (e 422) iron oxide (E172) Polysorbate 80 red iron oxide (E172) magnesium stearate
100 mg/25 mg mg/200 mg: titanium dioxide (E171) Hypromellose glycerol (e 422) Polysorbate 80 aluminium Lake Allura red (E129) Carmine (E120) 125 mg magnesium stearate/31.25 mg/200 mg: titanium dioxide (E171) hypromellose, glycerol (e 422) iron oxide (E172) Polysorbate 80 red iron oxide (E172) magnesium stearate 150 mg/200 mg 37.5 mg/: titanium dioxide (E171) Hypromellose glycerol (e 422) Polysorbate 80 red iron oxide (E172) aluminium Lake carmoisine (E102) magnesium stearate
175 mg/43.75 mg/200 mg: titanium dioxide (E171) Hypromellose glycerol (e 422) iron oxide (E172) Polysorbate 80 red iron oxide (E172) iron oxide (E172) 200 mg/50 mg magnesium stearate/200 mg: titanium dioxide (E171) Hypromellose glycerol (e 422) iron oxide (E172) Polysorbate 80 red iron oxide (E172) iron oxide (E172) magnesium stearate producing active ingredient Carbidopa Teva Pharmaceutical Fine Chemicals S.r. l Biantea State Road 36, Kilometers, Building No. 83, 23892-Bulciago, Lecco, Italy Production of the drug Levodopa--Ajinomoto co., Inc., 1-1 Suzuki-Cho, Kawasaki-Ku, Kawasaki, 210-8680, Japan-Guangxi Bonger Plant Products Co., Ltd., No. 223 The West DongNing Road, Industrial Zone, Tiandong County, Guangxi Province, 531 500, China-Guangxi Ling Yun Pharmaceutical Factory, No. 52 Dongfeng Road, Ling Yun Country, Shi Cheng Town, Guangxi Province, China-Teva Pharmaceutical Fine Chemicals S.r. l, highway Biantea Km 36, Building No. 83, Bulciago, Lecco, Italy, 23892-Teva Pharmaceutical Works Private Limited Company, Gyartelep, PF. 6, Hungary-3792, Sajobabony, Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13 4042, Debrecen, Hungary, production of the active ingredient Entacapone Neuland Laboratories Limited, Plot Nos. 92, 93, 94, 257, 258, 259, IDA, Pashamylarem, Isnapur (Village), Patancheru Mandal, Medak District, Hyderabad, Andhra Pradesh India 502 319, production, batch control, batch release, packaging TEVA Gyogyszergyar Zrt. (TEVA Pharmaceutical Works Private Limited Company) Debrecen, Pallagi ut 13, Hungary highly Release, packaging TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom batch release-Teva Pharma B.V., Swensweg 5, Haarlem, Netherlands-2031 GA Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, 89143-Merckle GmbH, Graf-arc batch Control Germany-Germany 3, 89079 Ulm, Str-outer packaging-NEOLOGISTIC S.r.l., Largo Boccioni, 1, I-21040 Origgio (VA)-Italy-Transpharm Logistik GmbH , Nicolaus-Otto-Straße 16, Ulm, 89079-Germany-CIT S.r.l., Via Primo Villa, 17-20040 Burago di Molgora (MB)-Italy-MoNo chem. Pharm. Produkte GmbH, Wien, Austria-Weather 1200-129, Farmagon 22, Karihaugveien 1086 1086 AS, Oslo, Oslo-Norway-Silvano Gordon Logistics S.P.A., Via Delle Industrie SNC-Livraga (LO), 26814-Italy medical indications: Levodopa/Carbidopa/Entacapone Teva is indicated for the treatment of adult patients with Parkinson's disease who exhibit motor fluctuations to end unregulated by treatment with levodopa dose/inhibitors of dopa decarboxylase (DDC).
Classification for the purposes of new listings ' Package ' 50 mg/200 mg/12.5 mg film-coated tablets "100 tablets in HDPE-AIC # 043128089 (10) 19458T (based on 32) new listings ' class «A» €34.19 ex factory Price (excluding VAT).
Price (VAT included) €64.12.
18.75 mg/75 mg/package 200 mg film-coated tablets "100 tablets in HDPE-AIC # 043128228 (10) 1945F4 (based on 32) new listings ' class «A» €34.19 ex factory Price (excluding VAT) retail price (tax included) €64.12 100 mg/25 mg/package 200 mg film-coated tablets" 100 tablets in HDPE-AIC # 043128356 (10) 1945K4 (based on 32) new listings ' class «A» €34.19 ex factory Price (excluding VAT).
Price (VAT included) €64.12.
Gift package "125 mg/31.25 mg/200 mg film-coated tablets" 100 tablets in HDPE-AIC # 043128483 (10) 1945P3 (32)

New listings ' class «A» €34.19 ex factory Price (excluding VAT).
Price (VAT included) €64.12.
Gift package "37.5 mg/150 mg/200 mg film-coated tablets" 100 tablets in HDPE-AIC # 043128610 (10) 1945T2 (based on 32) new listings ' class «A» €34.19 ex factory Price (excluding VAT).
Price (VAT included) €64.12.
Gift package "200 mg/50 mg/200 mg film-coated tablets" 100 tablets in HDPE-AIC # 043128875 (10) 19461C (based on 32) new listings ' class "A".
Ex factory price + VAT €34.19.
Price (VAT included) €64.12.
The classification of this determination takes effect, in accordance with art. 11, paragraph 1, last sentence, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, the day following the expiration of the patent or supplementary protection certificate, issued by the Ministry of economic development.
Until the expiry of the period referred to in the preceding paragraph, the drug LEVODOPA/CARBIDOPA/ENTACAPONE TEVA is classified, in accordance with art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 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).
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 the supply of the drug LEVODOPA/CARBIDOPA/ENTACAPONE TEVA is as follows: medicinal product subject to medical prescription (RR) terms and conditions of use of Prescription medicine subject to diagnosis-treatment plan and to the provisions of annex 2 as amended, October 29, 2004-PHT determination direct distribution-Guide, published in the ordinary supplement to the official journal # 259 of November 4, 2004.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 2 14 co. of Decree 219/2006 which forces do not 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 c, para. 2010/84/EC Directive 7) 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.