| Code | 4494E | ||||||||||
| MA number | EU/1/21/1613/003 | ||||||||||
| Product Form: | tbl flm 98x45 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
| Therapeutic Class: | 36 - ANTITUSSICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 15.09.2023 |
| Validity: | 15.09.2028 |
| Safety feature | Yes |
| Data update: | 27.09.2023 |
