| Code | 0645E | ||||||||||
| MA number | 87/0117/22-S | ||||||||||
| Product Form: | pas ocp 60(3x20)x4 mg (obal PP) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | OMEGA PHARMA a.s., Czechia | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 24.05.2022 |
| Validity: | 24.05.2027 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_NiQuitin Mini Citrus 4 mg lisované pastilky_03.2023.pdf
|
| PIL: |
PIL_NiQuitin Mini Citrus 4 mg lisované pastilky_05.2024.docx
|
| Safety feature | No |
| Data update: | 02.03.2023 |
