Authorisation For The Medicinal Product For Usoumano «Sumatriptan Accord. "

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Sumatriptan Accord».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-13&atto.codiceRedazionale=15A00942&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the 61/2015 January 29, 2015 n. MEDICINE: SUMATRIPTAN ACCORD.
MAh: Accord Healthcare Italy S.r.l. -Largo Esterle, 42052 Monza (MB).
Package: «50 mg film-coated tablets» 6 tablets in AL/AL;
A.I.C. # 042571012 (10) 18M584 (based on 32).
Package: «50 mg film-coated tablets» 12 tablets in AL/AL;
A.I.C. # 042571024 (10) 18M58J (based on 32).
Package: «100 mg film-coated tablets» 6 tablets in AL/AL;
A.I.C. # 042571036 (10) 18M58W (based on 32).
Package: «100 mg film-coated tablets» 12 tablets in AL/AL;
A.I.C. # 042571048 (10) 18M598 (based on 32).
Package: «50 mg film-coated tablets» 4 tablets in AL/AL;
A.I.C. # 042571063 (10) 18M59R (based on 32).
Package: «50 mg film-coated tablets» 18 tablets in AL/AL;
A.I.C. # 042571075 (10) 18M5B3 (based on 32).
Package: «100 mg film-coated tablets» 4 tablets in AL/AL;
A.I.C. # 042571087 (10) 18M5BH (based on 32).
Package: «100 mg film-coated tablets» 18 tablets in AL/AL;
A.I.C. # 042571099 (10) 18M5BV (based on 32).
Pharmaceutical form: film-coated tablet.
Composition: each film-coated tablet contains: active ingredient: 70 mg 50 mg sumatriptan succinate of sumatriptan;
140 mg sumatriptan succinate equivalent to 100 mg of sumatriptan.
Excipients: coated tablet from 50 mg tablet core: lactose monohydrate Hypromellose microcrystalline croscarmellose sodium magnesium stearate Film-coating: Hypromellose titanium dioxide (E 171) red iron oxide (E 172) Triacetin coated tablet from 100 mg tablet core: lactose monohydrate Hypromellose microcrystalline croscarmellose sodium magnesium stearate Film-coating: Hypromellose titanium dioxide (E 171) production: Intas Pharmaceuticals Limited-Plot No. 457-458, Matoda, Sanand, Bavla Sarkhej-Highway, Ahmedabad-382210, Gujarat-India.
Packaging: Intas Pharmaceuticals Limited-Plot No. 457-458, Matoda, Sanand, Bavla Sarkhej-Highway, Ahmedabad-382210, Gujarat-India.
Production active ingredient: Natco Pharma Limited-Chemical Division-Mekaguda village, Kothur Mandal, IND-509 223, Mahaboob Nagar District, Andhra Pradesh, India.
Batch release: Accord Healthcare Limited Sage house, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom.
Batch control: Astron Research Limited 2nd, 3rd Floor, Sage House, 319 Pinner Road, North Harrow, HA1 4HF, United Kingdom.
Medical indications: "sumatriptan tablets» are indicated for the treatment of acute attacks of migraine with or without aura. Sumatriptan should be used only in cases where there is a reliable diagnosis of migraine.
Classification for the purposes of new listings ' box: «50 mg film-coated tablets» 4 tablets in AL/AL;
A.I.C. # 042571063 (10) 18M59R (based on 32).
New listings: class "A".
Ex factory price (excluding VAT): €3.55.
Price (VAT included): €6.65.
Package: «100 mg film-coated tablets» 4 tablets in AL/AL;
A.I.C. # 042571087 (10) 18M5BH (based on 32).
New listings: class "A".
Ex factory price (excluding VAT): €7.68.
Price (VAT included): €14.40.
The packs referred to in art. 1, which are not classified listings there band ' for the purposes of this article, are placed, by virtue of art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, # 537 as amended, called class C (nn).
Classification for the purpose of the classification for the purposes of providing the medicine SUMATRIPTAN ACCORD is as follows: medicinal product subject to medical prescription (RR).
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) under art. 107-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following its publication in the official journal of the Italian Republic.