Gesuchs ID

Meilenstein

Grund der Einreichung

Initialen des Gutachtersls

102658307

Initial 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