Code | 0305E | ||||||||||
MA number | 09/0086/22-S | ||||||||||
Product Form: | cps end 112x40 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Medreg s.r.o., Czechia | ||||||||||
Therapeutic Class: | 09 - ANTACIDA (VRÁTANE ANTIULCEROSNYCH LIEČIV) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 28.04.2022 |
Validity: | 28.04.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Omeprazol Medreg_cps end_03_2023.pdf |
PIL: | PIL_Omeprazol Medreg_cps end_12_2023.pdf |
Safety feature | Yes |
Data update: | 29.04.2022 |