Amiodarone Zentiva 200 mg
Amiodarone Zentiva 200 mg is a medicine authorised by Swissmedic under authorisation number 53114. 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 05 June 1996 and the authorisation is valid without a time limit. ATC code C01BD01 places the medicine in the group Cardiac therapy.
| Authorisation number | 53114 |
|---|---|
| Name | Amiodarone Zentiva 200 mg |
| Full name | Amiodarone Zentiva 200 mg, Tabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | C01BD01 |
| First authorisation | 05 June 1996 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 2 | Amiodarone Zentiva 200 mg, Tabletten | B | 05 June 1996 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 76 | 20 | Tablette(n) | C01BD01 | 02.02.0. | B |
| 77 | 60 | Tablette(n) | C01BD01 | 02.02.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Amiodarone Zentiva 200 mg authorised in Switzerland?
Yes. Amiodarone Zentiva 200 mg is authorised by Swissmedic under authorisation number 53114, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Amiodarone Zentiva 200 mg have?
Amiodarone Zentiva 200 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 Amiodarone Zentiva 200 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.