Stand der InformationFebruar 2025
Revisions-Historie
Gesuchs ID
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Meilenstein
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Grund der Einreichung
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Initialen des Gutachtersls
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102658307
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Initial Submission
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MAA according to Art. 13 TPA, text according to approved EU-SmPC, amendments according to Swissmedic’s template and guidance
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PharmaContext
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102658307
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Response to Preliminary Decree
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Response to Preliminary Decree, Update of MAH, Deletion of pack with 98 capsules
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Response to Preliminary Decree
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102690352
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Label update – Desogestrel – Initial submission
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Label update for interaction with desogestrel and minor corrections
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Desogestrel
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102741102
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Type 1AIN variation – Response to Safety Signal Notification. Signal No. 102739454, approved 13 Nov 2024
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Revised wording to add postmarketing adverse event for nausea
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BCRX Type 1AIN
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102737333
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Type II variation – Study 119 Initial Submission
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Label update for interaction with ciclosporine. Clarification to Warnings and Precautions requested by EMA.
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BCRX
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