Code | 4492E | ||||||||||
MA number | EU/1/21/1613/001 | ||||||||||
Product Form: | tbl flm 28x45 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 |