| Code | 9994D | ||||||||||
| MA number | 73/0072/22-S | ||||||||||
| Product Form: | tbl flm 100x5 mg (blis.PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Aristo Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
| ATC: |
|
||||||||||
| 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 |
| Validity: | 22.04.2027 |
| MA renewed: | Renewal application submitted |
| 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: | 09.12.2022 |
