| Code | 9987D | ||||||||||
| MA number | 73/0073/22-S | ||||||||||
| Product Form: | tbl flm 50x10 mg (blis.PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Aristo Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 22.04.2022 |
| SPC: |
SPC_Aristissa 5 mg 10 mg tbl flm_12_2022.pdf
|
| PIL: |
PIL_Aristissa 5 mg 10 mg tbl flm_05_2024.pdf
|
| Safety feature | Yes |
| Data update: | 30.06.2025 |
