Given The New Designation Of The Medicinal Product For Human Use «Soliris».

Original Language Title: Comunicato per la nuova indicazione del medicinale per uso umano«Soliris».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=15A00036&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Specialty Soliris.
Please be advised that the scientific technical Committee, at its meeting on 9 June 10, 2014 and expressed a favourable opinion on the new listings, without changing the price and negotiating conditions currently in force for the new indication below: treatment of PNH in the pediatric population.
For the purposes of the NHS prescriptions, computerized data collection, users must complete the enrollment indicating eligible patients and follow-up, applying negotiation conditions according to the guidelines that are published on the Agency website, web platform-to the address https://www.agenziafarmaco.gov.it/registri/which form an integral part of this determination.
Pending the full implementation of the Register web-based tracking, prescriptions, relating solely to claims reimbursed by the NHS through this determination must be made in accordance with the criteria of eligibility and appropriateness prescriptive documentation available on the Agency's institutional Portal reported: http://www.agenziafarmaco.govit/it/content/registri-farmaci-sottopost i-monitoring data relating to the processing operations carried out from the date of entry into force of this determination through the modalities indicated above shall be subsequently given in temporary web platform, according to modalities which will be listed on the site: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottopos ti-monitoring