| Code | 49668 | ||||||||||
| MA number | 42/0033/07-S | ||||||||||
| Product Form: | tbl flm 8x500 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 29.01.2007 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric contraindication: | Yes | 
| Pediatric warnings: | Yes | 
| PIL: |  | 
| SPC: |  | 
| Safety feature | Yes | 
| Data update: | 05.12.2019 |