Review Product Marketing Authorisation For Human Use «Pronativ».

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

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Retrieved December 16, 2014 V&A/2625 of authorization determines variation: the B 3, c) in relation to medicine: PRONATIV European procedure: DE/H/0464/001/II/037 Mah: OCTAPHARMA ITALY SPA is hereby amended as follows: Add a new batch size for the cryo-poor plasma. The change applies to Octapharma in Vienna from: 1000 kg ± 10 batch size: cryo-poor plasma kg: batch size: 1000 kg ± 10 kg batch size: plasma cryo poor 2000 kg ± 20 kg of cryo poor plasma are amended also the following modules: 2.3 and 3.2. P. 3.3 relation to medicine PRONATIV, in the forms and packages listed below : 039240015-"500 IU powder and solvent for solution for infusion" 1 vial of powder + 1 vial of 20 ml solvent + transfer set has also changed, according to conforming to standards terms, the description of the Pack as indicated above, review the following handouts already attached to the determination V&A. PC/II/240/2011.
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 paragraph 5 of the AIFA 14/04/2014 # 371 of Determines published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.