Parallel Import Licence For Medicinal Usoumano «Pantorc».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-05&atto.codiceRedazionale=15A03269&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved April 15, 2015 V&A # 770 IP determines the parallel importation of a medicinal product authorized SOMAC gastro-resistant tablets 20 mg blister 56 tabs from Norway with 99-4148 authorization number (vnr. 545673), which for the reasons expressed above, must be marketed under the name PANTORC and 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.
Cpr 20 mg gastro-resistant blister pack: 14 PANTORC.
AIC code: 15ZGN6 039828102 (10) (32).
Pharmaceutical form: gastro-resistant;
Composition: each tablet contains: active ingredient: Pantoprazole 20 mg (as sodium sesquihydrate);
Excipients: core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone, calcium stearate K90. Coating: hypromellose, povidone K25, titanium dioxide (E171), iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulphate, triethyl citrate. Printing ink: shellac, iron oxide red, black and yellow (E172), strong ammonia solution.
Therapeutic indications adults and adolescents 12 years and older: treating symptoms (eg, heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease caused by reflux of acid from the stomach.
Long-term treatment of reflux oesophagitis (inflammation of the esophagus accompanied by regurgitation of acid from the stomach) and prevention of its recurrence.
Adults: prevention of stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.
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 is 20 mg gastro-resistant blister Pack: 14 cpr PANTORC.
AIC code: 039828102; 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.
Classification for the purposes of delivery set: 14 20 mg gastro-resistant blister cpr PANTORC.
AIC code: 039828102; RR-prescription medicines.
Date of determination: from the day following its publication in the official journal of the Italian Republic.