Authorization to produce and test the TEPADINA® flexible multi-chamber bag for the EU market

On March 13Th 2023, we have received from EMA: “Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorization for TEPADINA ®”. The Authorization: 1) B.II.b.2a (IA): to add ADIENNE S.r.l. (located at Via Galileo Galilei, 1920867 Caponago (MB) – Italy) as an alternative site responsible for quality control/testing of the finished product in addition to the current sites. 2) B.II.b.1z (II): to add ADIENNE S.r.l. (located at Via Galileo Galilei, 19 20867 Caponago (MB) – Italy) as an alternative site responsible for manufacturing of the finished product in addition to the current manufacturer. Confirms that ADIENNE Srl Plant is Authorize to produce and test TEPADINA® Multichamber Flexible Bag for the EU Market.

The release as fetched from its publisher. adienne.com ↗