Review Product Marketing Authorisation For Human Use "glycerol Carlo Erba».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Glicerolo Carlo Erba».

Read the untranslated law here:

Retrieved January 26, 2015 V&A # 95 determines the permission of variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, clinical or pharmacovigilance medicine GLYCEROL CARLO ERBA;
Authorized updating of the summary of product characteristics in section 5.3 and corresponding paragraph leaflet concerning the medicine GLYCEROL CARLO ERBA, in the forms and packages listed below: AIC # 029651015-"babyhood 900 mg suppositories" 12 suppositories;
AIC # 029651027-"children 1375 mg suppositories" 18 suppositories;
AIC # 029651039-"adults 2250 mg suppositories" 18 suppositories;
AIC # 029651054-"children 2.25 g rectal solution" 6 Unidose containers with chamomile and Mallow;
AIC # 029651066-"adults 6.75 g rectal solution" 6 Unidose containers with camomile and Mallow.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
Mah: CARLO ERBA O.T.C. S.R.L. (tax 08572280157) with registered office and tax domicile in Via Ardeatina km 23.500-Fraction loc. Santa Palomba, 00040-Pomezia-Rome (RM) Italy.
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. 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 aforementioned legislative decree.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in art. 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.