• -Historique des révisions
• -Nº de demande Jalon Modification Initiales
• -102658307 Inital Submission MAA according to Art. 13 TPA, text according to approved EU-SmPC, amendments according to Swissmedic’s template and guidance PharmaContext
• -102658307 Response to Preliminary Decree Response to Preliminary Decree, Update of MAH, Deletion of pack with 98 capsules Response to Preliminary Decree
• -102690352 Label update – Desogestrel – Initial submission Label update for interaction with desogestrel and minor corrections Desogestrel
• -102741102 Type 1AIN variation – Response to Safety Signal Notification. Signal No. 102739454, approved 13 Nov 2024 Revised wording to add postmarketing adverse event for nausea BCRX Type 1AIN
• -102737333 Type II variation – Study 119 Initial Submission Label update for interaction with ciclosporine. Clarification to Warnings and Precautions requested by EMA. BCRX
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