Renewal Of Marketing Authorisation, The Mutual Recognition Secondoprocedura, Of The Medicinal Product For Human Use "omeprazol Actavis Ptc», Resulting In A Review Printed.

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-31&atto.codiceRedazionale=15A02334&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 26, 2015 57/2015 # PV of Medicine determines: OMEPRAZOL ACTAVIS PTC.
Packaging: A.I.C. # 039758 014 «10 mg gastro-resistant capsules, hard» 7 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 026 «10 mg gastro-resistant capsules, hard» 14 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 038 «10 mg gastro-resistant capsules, hard» 15 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 040 «10 mg gastro-resistant capsules, hard» 28 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 053 «10 mg gastro-resistant capsules, hard» 30 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 065 «10 mg gastro-resistant capsules, hard» 50 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 077 «10 mg gastro-resistant capsules, hard» 56 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 089 «10 mg gastro-resistant capsules, hard» 60 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 091 «10 mg gastro-resistant capsules, hard» 90 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 103 ' 10 mg gastro-resistant capsules, hard» 98 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 115 «10 mg gastro-resistant capsules, hard 100 capsules» OPA-ALU-PVC/ALU;
A.I.C. # 039758 127 «10 mg gastro-resistant capsules, hard» 140 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 139 «10 mg gastro-resistant capsules, hard» 280 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 141 «10 mg gastro-resistant capsules, hard» 500 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 154 «10 mg gastro-resistant capsules, hard» 7 capsules in HDPE container;
A.I.C. # 039758 166 ' 10 mg gastro-resistant capsules, hard» 14 capsules in HDPE container;
A.I.C. # 039758 178 «10 mg gastro-resistant capsules, hard» 28 capsules in HDPE container;
A.I.C. # 039758 180 ' 10 mg gastro-resistant capsules, hard» 30 capsules in HDPE container 10 mg # 039758 192 A.I.C. «gastro-resistant capsules, hard» 56 capsules in HDPE container;
A.I.C. # 039758 204 «10 mg gastro-resistant capsules, hard» 60 capsules in HDPE container;
A.I.C. # 039758 216 «10 mg gastro-resistant capsules, hard» 90 capsules in HDPE container;
A.I.C. # 039758 228 «10 mg gastro-resistant capsules, hard» 100 capsules in HDPE container;
A.I.C. # 039758 230 «10 mg gastro-resistant capsules, hard» 500 capsules in HDPE container;
A.I.C. # 039758 242 «20 mg gastro-resistant capsules, hard» 500 capsules in HDPE container;
A.I.C. # 039758 255 «20 mg gastro-resistant capsules, hard» 100 capsules in HDPE container;
A.I.C. # 039758 267 «20 mg gastro-resistant capsules, hard» 90 capsules in HDPE container;
A.I.C. # 039758 279 «20 mg gastro-resistant capsules, hard» 60 capsules in HDPE container;
A.I.C. # 039758 281 «20 mg gastro-resistant capsules, hard» 56 capsules in HDPE container;
A.I.C. # 039758 293 «20 mg gastro-resistant capsules, hard» 30 capsules in HDPE container;
A.I.C. # 039758 317 «20 mg gastro-resistant capsules, hard» 28 capsules in HDPE container;
A.I.C. # 039758 329 «20 mg gastro-resistant capsules, hard» 14 capsules in HDPE container;
A.I.C. # 039758 331 «20 mg gastro-resistant capsules, hard» 7 capsules in HDPE container;
A.I.C. # 039758 343 20 mg gastro-resistant capsules, hard «»» 7 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 356 «20 mg gastro-resistant capsules, hard» 14 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 368 «20 mg gastro-resistant capsules, hard» 15 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 370 «20 mg gastro-resistant capsules, hard» 28 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 382 «20 mg gastro-resistant capsules, hard» 30 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 394 20 mg gastro-resistant capsules, hard «» 50 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 406 «20 mg gastro-resistant capsules, hard» 56 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 418 «20 mg gastro-resistant capsules, hard» 60 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 420 «20 mg gastro-resistant capsules, hard» 90 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 432 «20 mg gastro-resistant capsules, hard» 98 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 444 «20 mg gastro-resistant capsules, hard 100 capsules» OPA-ALU-PVC/ALU;
A.I.C. # 039758 457 «20 mg gastro-resistant capsules, hard» 140 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 469 «20 mg gastro-resistant capsules, hard» 280 capsules in OPA-ALU-PVC/ALU;
A.I.C. # 039758 471 «20 mg gastro-resistant capsules, hard» 500 capsules in OPA-ALU-PVC/ALU.
A.I.C. Holder: Actavis Group PTC EHF.
Mutual recognition procedure IF/H/001-001/003/R/0754, expiring on May 30, 2013 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.
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 subsequent amendments and supplements the leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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 art. 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 period of thirty days from the date of publication in the Official Gazette of the Italian Republic of this determination. The A.I.C. holder 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.