| Code | 3103F | ||||||||||
| MA number | 19/0015/26-S | ||||||||||
| Product Form: | tbl flm 20x300 mg (blis.PVC/PVDC-Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Olikla s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 08.04.2026 |
| Validity: | 08.04.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Penicillamine Olikla_04.2026.pdf
|
| SPC: |
SPC_Penicillamine Olikla_04.2026.pdf
|
| Safety feature | Yes |
| Data update: | 09.04.2026 |
