en

PRODUCT DETAIL

Baclofen Sintetica 2 mg/ml infúzny roztok

Code 2908E
MA number 63/0139/18-S
Product Form: sol inf 10x5 ml/10 mg (amp.skl.-fialový krúž.v steril.plast.blis.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
MAH, country: Sintetica GmbH, Germany
Therapeutic Class: 63 - MYORELAXANTIA
ATC:
M MUSCULO-SKELETAL SYSTEM
M03 MUSCLE RELAXANTS
M03B MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03BX Other centrally acting agents
M03BX01 Baclofen
Shelf life: 60
Container: glass ampoule
Route of admin.: Intrathecal use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 28.06.2018
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Baclofen Sintetica 2mg_ml infúzny roztok_01_2023.pdf  
PIL: PIL_Baclofen Sintetica 2mg_ml infúzny roztok_02_2023.pdf  
Safety feature Yes
Data update: 17.03.2023
eu-flag.png sk-flag.png