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

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

Read the untranslated law here:

Retrieved February 26, 2015 2015 # 59/PV determines the Medicine: VENLAFAXINE EUROGENERICI.
Packaging: 03884 019 «37.5 mg tablets» PVC/ACLAR/7 tablets at 37.5 mg 10 tablets 03884 021 «tablets» PVC/ACLAR/at 37.5 mg tablets 14 03884 033 «» PVC/ACLAR/tablets to 37.5 mg 15 tablets 03884 045 «tablets» PVC/ACLAR/at 37.5 mg 20 tablets 03884 058 «tablets» PVC/ACLAR/at 37.5 mg tablets 28 03884 060 «» PVC/ACLAR/tablets to 37.5 mg tablets 30 tablets 03884 072 «» PVC/ACLAR/AL 03884 084 ' 37.5 mg tablets» 50 tablets in PVC/ACLAR/at 37.5 mg tablets 56 tablets 03884 096 «» PVC/ACLAR/37.5 mg tablets 60 tablets at 03884 108 «» PVC/ACLAR/at 37.5 mg 84 tablets 03884 110 «tablets» PVC/ACLAR/37.5 mg tablets 90 tablets at 03884 122 «» PVC/ACLAR/AL 03884 134 «ACLAR/tablets 37.5 mg tablets» PVC/98 to 37.5 mg tablets 100 tablets 03884 146 «» PVC/ACLAR/37.5 mg tablets at 03884 159 «» 112 tablets in PVC/ACLAR/at 37.5 mg tablets 120 tablets 03884 161 «» PVC/ACLAR/at 37.5 mg tablets 150 03884 173 «» PVC/ACLAR/tablets to 37.5 mg tablets 200 tablets 03884 185 «» PVC/ACLAR/AL Mah: EG S.P.A.
Mutual recognition procedure DE/H/1489/001/R/001.
Date of 11/6/2012 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 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 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 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.