Parallel Import Licence For Medicinal Usoumano «Yasminelle».

Original Language Title: Autorizzazione all'importazione parallela del medicinale per usoumano «Yasminelle».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-05&atto.codiceRedazionale=15A03268&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved April 15, 2015 V&A # 771 IP determines the parallel importation of a medicinal product authorized YASMINELLE comprimidos revestidos por pelicula (film coated tablets) 0, 02mg + 3 mg/Tab 3 × 21 comp. from Portugal with return authorization number 5866280 with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination.
Importer: integrated health Programs s.r.l., Via g. Lanza, 3-20121 Milan.
Package: YASMINELLE "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL.
AIC code: 165B1S 040020024 (10) (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 Falorni s.r.l. Via Provinciale Lucchese-Loc. Masotti 51030 Serravalle Pistoiese (PT); S.C.F. S.n.c. By Gano Roberto and Claudio F 7-26824 Pelizzola Mirko Barbarossa, Cavenago d'Adda-LO; PHARM @ IDEA s.r.l. Via del Commercio, 5-25039 Travagliato (BS); STM Group S.r.l. Via Artemisia Gentileschi, 26-80126 Naples;
Classification for the purposes of new listings ' box: YASMINELLE "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL.
AIC code: 040020024; New listings ' class: C (nn).
The above package is placed in "special section" of the classroom under 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), pending the submission by the holder of the AIP a possible application for different classification.
Package: YASMINELLE "3 mg + 0.02 mg film-coated tablets" 21 tablets in PVC/AL.
AIC code: 040020024; RR-medicinal product subject to medical prescription;
Date of determination: from the day following its publication in the official journal of the Italian Republic.