| Code | 7587E | ||||||||||
| MA number | 42/0247/24-S | ||||||||||
| Product Form: | cps dur 20x50 mg ((blis.Al s povl.VMCH (25 mikr.) a PVC nepr.fil. (250 mikr.)) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Olikla s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 25.09.2024 | 
| Validity: | 25.09.2029 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric contraindication: | Yes | 
| SPC: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 07.10.2024 |