Code | 9834D | ||||||||||
MA number | 15/0054/22-S | ||||||||||
Product Form: | plo ijf 5x20 ml (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Olikla s.r.o., Czechia | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 17.03.2022 |
Validity: | 17.03.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Amoxicillin_Clavulanic Acid Olikla 1 000 mg_200 mg prášok_plo ijf_04.2023.pdf |
SPC: | SPC_Amoxicillin_Clavulanic Acid Olikla 1 000 mg_200 mg prášok_plo ijf_04.2023.pdf |
Safety feature | Yes |
Data update: | 28.03.2022 |