Retrieved February 23, 2015 V&A IP determines the authorized # 350 parallel imports of the medicinal product DEPAKINE Chrono 500 mg, prelungită 1 cu compressed eliberare flacon PP (tablet container) 30 comp. from Romania with permission number 1671/2009/01 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: Depakote "Chrono 500 mg extended release tablet" 30 tablets bottle PP AIC Code: 043708015 (10) 19PVMH (based on 32) extended release tablets dosage form: each tablet contains: active ingredient: 333.0 mg sodium valproate-valproic acid 145.0 mg (corresponding to 500 mg of sodium valproate);
core: ethylcellulose, Hypromellose 4000 colloidal hydrated silica dioxide, colloidal silicon dioxide, sodium saccharine. Movie: hypromellose, Polyacrylate dispersion 30%, Macrogol 6000, talc, titanium dioxide (E171) therapeutic indications in the treatment of epilepsy, generalized attacks, especially in generalized tonic-clonic, Myoclonic, absence, atonic, mixed, and partial Epilepsy: simple or complex, secondarily generalized.
In the treatment of specific syndromes (West, Lennox-Gastaut syndrome).
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 di Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda-LO.
Classification for the purposes of new listings ' box: Depakote "Chrono 500 mg extended release tablet" 30 tablets bottle PP Code AIC: 043708015. 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: Depakote "Chrono 500 mg extended release tablet" 30 tablets bottle PP Code AIC: 043708015. 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.