Code | 7030D | ||||||||||
MA number | 15/0455/05-S | ||||||||||
Product Form: | plv iii 56x2 M IU (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 15.12.2005 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_KOLOMYCÍN 1 milión IU a 2 milióny IU_08.2023.pdf |
SPC: | SPC_KOLOMYCÍN 1 milión IU a 2 milióny IU_08.2023.pdf |
Safety feature | Yes |
Data update: | 17.03.2021 |