Renewal Of The Marketing Authorisation For The Medicinal Product For Human Use Mutual Recognition Secondoprocedura «Ribavirin Sandoz ", Resulting In A Review Printed.

Original Language Title: Rinnovo dell'autorizzazione all'immissione in commercio secondoprocedura di mutuo riconoscimento del medicinale per uso umano«Ribavirina Sandoz», con conseguente modifica stampati.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-27&atto.codiceRedazionale=15A00409&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 # PV 403/2014 of Medicine determines: Ribavirin SANDOZ Packs: 040558 013 "200 mg capsule" 7 capsules in AL/PVC/PCTFE 040558 025 "200 mg capsule" 14 capsules in AL/PVC/PCTFE 040558 037 "200 mg capsule" 21 capsules in AL/PVC/PCTFE 040558 049 "200 mg capsule" 28 capsules in AL/PVC/PCTFE 040558 052 "200 mg capsule" 35 capsules in AL/PVC/PCTFE 040558 064 "200 mg capsule 42" capsules in AL/PVC/PCTFE 040558 076 "200 mg capsule" 49 capsules in AL/PVC/PCTFE 040558 088 "200 mg capsule" 56 capsules in AL/PVC/PCTFE 040558 090 "200 mg capsule" 63 capsules in AL/PVC/PCTFE 040558 102 "200 mg capsule" 70 capsules in AL/PVC/PCTFE 040558 114 "200 mg capsule" 77 capsules in AL/PVC/PCTFE 040558 126 "200 mg hard capsules 84 capsules "AL/PVC/PCTFE 040558 138 91 capsules 200 mg capsules," "AL/PVC/PCTFE 040558 140 ' 200 mg capsule" 98 capsules in AL/PVC/PCTFE 040558 153 "200 mg capsule" 105 capsules in AL/PVC/PCTFE 040558 165 "200 mg capsule" 112 capsules in AL/PVC/PCTFE 040558 177 "200 mg capsule" 119 capsules in AL/PVC/PCTFE 040558 189 200 mg capsule " rigid "126 capsules in AL/PVC/PCTFE 040558 191" 200 mg capsule "133 capsules in AL/PVC/PCTFE 040558 203" 200 mg capsule "140 capsules in AL/PVC/PCTFE 040558 215" 200 mg capsule "147 capsules in AL/PVC/PCTFE 040558 227" 200 mg capsule "154 capsules in AL/PVC/PCTFE 040558 239" 200 mg capsule "161 capsules in AL/PVC/PCTFE 040558 241" 200 mg capsule "168 capsules in AL/PVC/PCTFE 040558 254 "200 mg capsule" 175 capsules in AL/PVC/PCTFE 040558 266 "200 mg capsule" 182 capsules in AL/PVC/PCTFE 040558 278 "200 mg capsule" 189 capsules in AL/PVC/PCTFE 040558 280 "200 mg capsule" 196 capsules in AL/PVC/PCTFE Mah: SANDOZ S.P.A.
Mutual recognition procedure AT/H/0331/001/R/001 date of 22/04/2014 is renewed, with unlimited validity, the marketing authorisation subject to amendment of the summary of product characteristics, package leaflet and labelling and on condition that, on the date of entry into force of this determination, the requirements of quality, safety and efficacy are still present.
The mAh of 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 mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14 co. 2 of legislative decree 219/2006, in virtue of which are not included in the printed 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 generic medicine.
It also approved the change AT/H/001/007/IA/0331-C1A/2014/1976 concerning the update of the summary of product characteristics and package leaflet Ilustrativo.
Changes must be made immediately to the summary of the product characteristics as per the package leaflet and labelling no later than six months after its publication in the Official Gazette of the Italian Republic of this determination.
In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s 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 Decree.
Both lots already products as of the date of publication in the official journal of the Italian Republic of this determination that the batches produced during the period referred to in article 2, paragraph 2, of the aforementioned determination, which did not indicate the changes authorized, can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The mAh makes accessible to pharmacist leaflet updated within the same timeframe.
This determination takes effect from the day following that of its publication in the official journal of the Italian Republic and will be notified to the company holder of the marketing authorisation of the medicinal product.