Stand der Information

Februar 2025
Revisions-Historie

Gesuchs ID            Meilenstein                  Grund der Einreichung        Initialen des
                                                                                Gutachtersls
102658307             Initial Submission           MAA according to Art. 13     PharmaContext
                                                   TPA, text according to       
                                                   approved EU-SmPC,            
                                                   amendments according to      
                                                   Swissmedic’s template and    
                                                   guidance                     
102658307             Response to Preliminary      Response to Preliminary      Response to Prelimin
                      Decree                       Decree, Update of MAH,       ary Decree
                                                   Deletion of pack with 98     
                                                   capsules                     
102690352             Label update – Desogestrel   Label update for interactio  Desogestrel
                      – Initial submission         n with desogestrel and       
                                                   minor corrections            
102741102             Type 1AIN variation –        Revised wording to add       BCRX Type 1AIN
                      Response to Safety Signal    postmarketing adverse        
                      Notification. Signal No.     event for nausea             
                      102739454, approved 13 Nov                                
                      2024                                                      
102737333             Type II variation – Study    Label update for interactio  BCRX
                      119 Initial Submission       n with ciclosporine.         
                                                   Clarification to Warnings    
                                                   and Precautions requested    
                                                   by EMA.