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PRODUCT DETAIL

Derin Prolong 400 mg

Code 3667C
MA number 68/0117/17-S
Product Form: tbl plg 60x400 mg (blis.PVC/PCTFE/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 68 - ANTIPSYCHOTICA (NEUROLEPTICA)
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05A ANTIPSYCHOTICS
N05AH Diazepines, oxazepines, thiazepines and oxepines
N05AH04 Quetiapine
Shelf life: 36
Container: blister PVC/PCTFE/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 27.04.2017
Validity: 27.04.2022
MA renewed: Renewal application submitted
Pediatric warnings: Yes
SPC: SPC_Derin Prolong_02_2022.pdf  
PIL: PIL_Derin Prolong 02_2022.pdf  
Safety feature Yes
Data update: 17.04.2018
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