| Code | 36377 | ||||||||||
| MA number | 87/0398/06-S | ||||||||||
| Product Form: | tbl mnd 20x500 mg (fľ.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Takeda Pharmaceuticals International AG Ireland Branch, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 8(3) application - new active substance | 
| MA issued: | 27.09.2006 | 
| Pediatric warnings: | Yes | 
| PIL: |  | 
| SPC: |  | 
| Safety feature | Yes | 
| Data update: | 18.04.2023 |