Retrieved March 20, 2015 V&A IP determines the authorized # 568 parallel imports of the medicinal product MELIANE 3 × 21 tab from Belgium with return authorization number BE 174124, who, for the reasons expressed above, must be marketed under the name Phaedra and with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination : importer: Farmed s.r.l., 80143 Napoli Centro Direzionale Isola G1-.
Package: PHAEDRA "0.075 MG + 0.02 film-coated tablets" 21 tablets.
AIC code: 19RRSP 043769013 (10) (32).
Pharmaceutical form: film-coated tablets.
Composition: each tablet contains active ingredient: 0.075 mg Gestodene, ethinylestradiol 0.02 mg;
Excipients: lactose monohydrate, maize starch, povidone, talc, magnesium stearate, 25,000 sucrose, povidone 700,000, macrogol 6,000; calcium carbonate, Ester etilenglicolico Montan acid esters (E).
Therapeutic indications Prevention of conception.
Secondary packaging is authorized repackaging secondary Health workshops S.r.l. via Antonio Biasini, 26-26015 Soresina (CR).
Classification for the purposes of new listings ' box: Phaedra "0.075 mg + 0.02 film-coated tablets" 21 tablets.
AIC code: 043769013; 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: Phaedra "0.075 mg + 0.02 film-coated tablets" 21 tablets.
AIC code: 043769013; RR-prescription medicines.
Date of application of the determination on the day following its publication in the official journal of the Italian Republic.