| Code | 4336E | ||||||||||
| MA number | 69/0207/23-S | ||||||||||
| Product Form: | aer ors 1x15 ml/84 vstrekov (fľ.HDPE s dáv.pumpou) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 05.10.2023 |
| Validity: | 05.10.2028 |
| PIL: |
PIL_Oroflurb_09_2023.pdf
|
| SPC: |
SPC_Oroflurb_09_2023.pdf
|
| Dokument: |
VHS_Oroflurb_Flurbiprofen STADA_SK_H_0294_0311_001_DC_PAR.doc
|
| Dokument: |
VHS_Oroflurb_Flurbiprofen STADA_SK_H_0294_0311_001_DC_summary PAR.doc
|
| Safety feature | No |
| Data update: | 06.10.2023 |
