Parallel Imports Of The Medicinal Product For Human Use «Yasminelle»

Original Language Title: Importazione parallela del medicinale per uso umano «Yasminelle»

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00506&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 29, 2014 V&A # 2720 IP determines the parallel importation of a medicinal product authorized YASMINELLE comprimidos revestidos por pelicula (film coated tablets) + 3 mg 0.02 mg/Tab 3x21 comp. from Portugal with return authorization number 5866280, with the specifications below and provided that they are valid and effective on the date of entry into force of this determination.
Importer: Gekofar S.r.l., piazza Duomo # 16-20122 Milano.
Package: Yasminelle "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL-A.I.C. Code # 043632013 (10) 19MKDF (based on 32).
Dosage form: tablets.
Composition: each tablet contains: active ingredients: 0.020 mg of ethinyl estradiol (as betadestrina clathrate) and 3 mg drospirenone;
Excipients: lactose monohydrate, maize starch, magnesium stearate (E470b), hypromellose (E464), talc (E553b), titanium dioxide (E 171), red iron oxide (E 172).
Therapeutic indications Yasminelle is a contraceptive pill used to prevent pregnancy.
The outer packaging and secondary packaging are allowed at le officine Fiege Logistics Italy S.p.A., via Amendola # 1-20090 Caleppio di Settala (MI); S.C.F. S.n.c. By Gano Roberto and Claudio, via f. Pelizzola Mirko Barbarossa # 7-26824 Cavenago d'Adda-LO; CIT S.r.l., via Primo Villa # 17-20875 Burago Molgora (MB).
Classification for the purposes of new listings ' box: Yasminelle "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL-A.I.C. Code # 043632013; new listings ' class: C (nn).
The above package is placed in "special section" of the class referred to in art. 8, paragraph 10) (c) of law No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn), pending the submission by the holder of the AIP a possible application for different classification.
Classification for the purposes of delivery set: Yasminelle "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL-A.I.C. Code # 043632013; RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.