Omeprazol Zentiva 10 mg
Omeprazol Zentiva 10 mg is a medicine authorised by Swissmedic under authorisation number 56313. The authorisation holder is Helvepharm AG. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 26 May 2004 and the authorisation is valid without a time limit. ATC code A02BC01 places the medicine in the group Drugs for acid related disorders.
| Authorisation number | 56313 |
|---|---|
| Name | Omeprazol Zentiva 10 mg |
| Full name | Omeprazol Zentiva 10 mg, Filmtabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A02BC01 |
| First authorisation | 26 May 2004 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Omeprazol Zentiva 10 mg, Filmtabletten | B | 26 May 2004 |
| 2 | Omeprazol Zentiva 20 mg, Filmtabletten | B | 26 May 2004 |
| 3 | Omeprazol Zentiva 40 mg, Filmtabletten | B | 26 May 2004 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 14 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 3 | 28 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 5 | 56 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 7 | 98 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 11 | 14 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 13 | 28 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 15 | 56 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 17 | 98 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 21 | 28 | Tablette(n) | A02BC01 | 04.99.0. | B |
| 23 | 56 | Tablette(n) | A02BC01 | 04.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Omeprazol Zentiva 10 mg authorised in Switzerland?
Yes. Omeprazol Zentiva 10 mg is authorised by Swissmedic under authorisation number 56313, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Omeprazol Zentiva 10 mg have?
Omeprazol Zentiva 10 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Omeprazol Zentiva 10 mg?
The authorisation holder is Helvepharm AG. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.