When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
This medicinal product was covered by the defined scope of modafinil’s referral under Article 31 of Directive 2001/83/EC, as amended (procedure: EMEA/H/A-31/1186).
Cephalon hereby declares that the updated Summary of Product Characteristics is identical for the concerned sections to that annexed to the Commission Decision (issued on 27 Jan 2011) on the referral procedure for the reference medicinal product.
The local text of the marketing authorisation has been adapted to the final product information of the outcome of the Referral.
White to off-white, capsule-shaped tablets, debossed with “100” on one side.
(1)Change to Section 7 to update MA holder address details;
(2)Update of section 2, Qualitative and Quantitative Composition to include a statement on the contain of lactose monohydrate per tablet; reference to section 6.1 for a full list of excipients.
(3) Section 6.1 to add E-numbers for microcrystalline cellulose & Povidone
(4) Section 6.4 amend to state that this medicinal product does not require any special storage conditions
(5) Section 6.6 to state that there are no special requirements regarding instructions for use/handling.
Section 4.8 (undesirable effects): Update of the safety information on skin and subcutaneous tissue disorders, immune system disorders as well as psychiatric disorders.