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PRODUCT DETAIL

Calypsol

Code 87814
MA number 05/0301/94-S
Product Form: sol inj 5x10 ml/500 mg (liek.skl.hnedá)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
MAH, country: Gedeon Richter Plc., Hungary
Therapeutic Class: 05 - ANAESTHETICA (CELKOVÉ)
ATC:
N NERVOUS SYSTEM
N01 ANESTHETICS
N01A ANESTHETICS, GENERAL
N01AX Other general anesthetics
N01AX03 Ketamine
Shelf life: 60
Container: brown glass container
Route of admin.: Intramuscular or intravenous use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 10a well-established use application
MA issued: 19.05.1994
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Calypsol_11_2019.doc  
PIL: PIL_Calypsol_11_2019.doc  
Safety feature Yes
Data update: 06.12.2018
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