Retrieved January 14, 2015 V&A # 13/2015 determines the Description and attribution number A.I.C.
Authorised the placing on the market of the medicinal product HP, shapes and PREGNYL packs: «250 IU/l ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 1000 IU/1 ml 2 needles, «powder and solvent for injectable solution prefilled syringe 1 vial powder + 1" solvent with 2 needles, "2000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1" solvent with 2 needles in addition to the packs already authorised, under the conditions and with the specifications below.
A.I.C. holder: IBSA Italy Pharmaceutical S.r.l., via Martiri Di Cefalonia, 2-26900 Lodi (Italy), tax code 10616310156.
Packaging: 1 250 IU/ml "powder and solvent for injectable solution prefilled syringe 1 vial powder + 1" solvent with 2 needles;
A.I.C. # 003763289 (10) 03LV2T (based on 32);
pharmaceutical form: powder and solvent for solution for injection;
composition-active ingredient: 250 chorionic gonadotropin I.u.;
«1000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763291 (10) 03LV2V (based on 32);
pharmaceutical form: powder and solvent for solution for injection;
composition-active ingredient: 1000 chorionic gonadotropin I.u.;
«2000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763303 (10) 03LV37 (based on 32);
pharmaceutical form: powder and solvent for solution for injection;
composition-active ingredient: 2000 Iu human chorionic gonadotropin
Classification for the purposes of new listings is 250 IU/1 ml Packs: "powder and solvent for injectable solution prefilled syringe 1 vial powder + 1" solvent with 2 needles;
A.I.C. # 003763289;
new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn);
«1000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763291;
new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn);
«2000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763303;
new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purpose of packaging: «250 IU/1 ml powder and solvent for solution for injection» 1 vial powder + 1 syringe of solvent with 2 needles;
A.I.C. # 003763289;
RR: medicinal product subject to medical prescription;
«1000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763291;
RR: medicinal product subject to medical prescription;
«2000 IU/1 ml powder and solvent for injectable solution prefilled syringe 1 vial powder + 1 "solvent with 2 needles;
A.I.C. # 003763303;
RR: medicinal product subject to medical prescription.
Packaging of printed material should be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt to the determination, under this extract.
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 aforementioned legislative decree.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.