| Code | 8917C | ||||||||||
| MA number | 49/0251/18-S | ||||||||||
| Product Form: | gto por 1x10 ml (fľ.skl.hnedá) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Pharmanovia A/S, Denmark | ||||||||||
| Therapeutic Class: | 49 - DIGESTIVA, ADSORBENTIA, ACIDA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | brown glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 12.09.2018 |
| Validity: | 12.09.2023 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Dropizol 10 mg_ml_gto por_08_2019.doc
|
| PIL: |
PIL_Dropizol 10 mg_ml_gto por_08_2019.doc
|
| Safety feature | Yes |
| Data update: | 26.08.2019 |
