| Code | 95562 | ||||||||||
| MA number | 15/0455/05-S | ||||||||||
| Product Form: | plv iii 10x2 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 |
| SPC: |
SPC_KOLOMYCÍN 1 milión IU a 2 milióny IU_08.2023.pdf
|
| PIL: |
PIL_Kolomycín 1MIU a 2MIU_01.2025.pdf
|
| Safety feature | Yes |
| Data update: | 19.08.2019 |
