| Code | 42665 | ||||||||||
| MA number | 09/0573/96-S | ||||||||||
| Product Form: | tbl ent 28x20 mg (liek.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Hikma Farmaceutica (Portugal) S.A., Portugal | ||||||||||
| Therapeutic Class: | 09 - ANTACIDA (VRÁTANE ANTIULCEROSNYCH LIEČIV) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | container HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.07.1996 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_OPRAZOLE_tbl ent_04_2023.pdf
|
| SPC: |
SPC_OPRAZOLE_tbl ent_04_2023.pdf
|
| Safety feature | Yes |
| Data update: | 10.01.2018 |
