Retrieved December 9, 2014 2014 # 2592 V&A/determines the authorized the following variation: introduction of the Risk Management Plan concerning the medicinal product RISPERDAL and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: DE/H/2184/002-016/II/035 type of variation: C.I. 11. b) Changes relating to the safety, efficacy and pharmacovigilance medicines for human and veterinary use Introduction of obligations and conditions relating to a licence.
Mah:. JANSSEN CILAG S.P. stock disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 paragraph 5 of the April 14, 2014 # 371 Determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.