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PRODUCT DETAIL

BOTOX 100 Allergan Units

Code 75241
MA number 63/0021/93-S
Product Form: plv ino 1x10 ml/100 U (liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 63 - MYORELAXANTIA
ATC:
M MUSCULO-SKELETAL SYSTEM
M03 MUSCLE RELAXANTS
M03A MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03AX Other muscle relaxants, peripherally acting agents
M03AX01 Botulinum toxin
Shelf life: 36
Container: glass vial
Route of admin.: Intramuscular and subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 08.06.1993
Pediatric indication: Yes
Pediatric posology: Yes
PIL: PIL_Botox 50 100 Allergan Units_februar2021.docx  
SPC: SPC_Botox 50, 100 Allergan Units_februar2021.docx  
Safety feature Yes
Data update: 16.04.2018
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