| Code | 0955F | ||||||||||
| MA number | 73/0287/25-S | ||||||||||
| Product Form: | cps enm 45x182 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bionorica SE, Germany | ||||||||||
| Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 15.10.2025 |
| Validity: | 15.10.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Digelib_cps enm_09/2025_REG.pdf
|
| PIL: |
PIL_Digelib_cps enm_09/2025_REG.pdf
|
| Safety feature | No |
| Data update: | 16.10.2025 |
