Code | 9378D | ||||||||||
MA number | 53/0001/22-S | ||||||||||
Product Form: | sol inr 96(16x6)x10 ml/10 mg(striek.inj.napl.cykloolef.kopolymér+96 steril.adaptérov-nem.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 53 - PARASYMPATHOLYTICA, GANGLIOPLEGICA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | pre-filled syringe | ||||||||||
Route of admin.: | Intravesical use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 14.07.2022 |
Validity: | 14.07.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Velariq 1 mg_ml intravezikálny roztok_07_2022.pdf |
SPC: | SPC_Velariq 1 mg_ml intravezikálny roztok_07_2022.pdf |
Safety feature | Yes |
Data update: | 21.07.2022 |