Retrieved February 23, 2015 V&A IP determines the authorized # 349 parallel imports of the medicinal product YAZ 3 mg 0.02 mg/28 compressed filmed (1 × 28 compressed) from Romania with permission number 5060/2012/01 with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination.
Importer: Farmavox S.r.l., Via Giuseppe Parini 9-20121 Milan.
Package: Yaz "0.02 mg/3 mg film-coated tablets" 28 tablets in pvc/AIC code: 043709017 (10) 19PWLT (based on 32) dosage form: light pink active tablets, coated tablets: active ingredients: 0.020 mg Ethinylestradiol (as clathrate beta dextrin); Drospirenone 3 mg;
excipients: core: lactose monohydrate, maize starch, magnesium stearate;
coating: hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172);
placebo tablets, white: these tablets do not contain active ingredients, excipients: core: lactose monohydrate, maize starch, magnesium stearate, povidone K 25.
coating: hypromellose, talc, titanium dioxide (E 171).
Medical indications: Yaz is an oral contraceptive pill used to prevent pregnancy.
The outer packaging and secondary packaging are allowed at the officine CIT S.r.l., Via Primo Villa 17, 20875 Burago di Molgora (MB); S.C.F. S.n. c. of Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda-LO.
Classification for the purposes of new listings package: Yaz "0.02 mg/3 mg film-coated tablets" 28 tablets in pvc/AIC code: 043709017. 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 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.
Classification for the purposes of delivery set: Yaz "0.02 mg/3 mg film-coated tablets" 28 tablets in pvc/AIC code: 043709017. RR-medicinal product subject to medical prescription.
Date of application of the determination on the day following its publication in the official journal of the Italian Republic.