Pramipexol ER Zentiva 0.375 mg
Pramipexol ER Zentiva 0.375 mg is a medicine authorised by Swissmedic under authorisation number 65878. 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 27 July 2016 and the authorisation is valid without a time limit. ATC code N04BC05 places the medicine in the group Anti-Parkinson drugs.
| Authorisation number | 65878 |
|---|---|
| Name | Pramipexol ER Zentiva 0.375 mg |
| Full name | Pramipexol ER Zentiva 0.375 mg, Retardtabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N04BC05 |
| First authorisation | 27 July 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Pramipexol ER Zentiva 0.375 mg, Retardtabletten | B | 27 July 2016 |
| 2 | Pramipexol ER Zentiva 0.75 mg, Retardtabletten | B | 27 July 2016 |
| 3 | Pramipexol ER Zentiva 1.5 mg, Retardtabletten | B | 27 July 2016 |
| 4 | Pramipexol ER Zentiva 3.0 mg, Retardtabletten | B | 27 July 2016 |
| 5 | Pramipexol ER Zentiva 4.5 mg, Retardtabletten | B | 27 July 2016 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 | Tablette(n) | N04BC05 | 01.08.0. | B |
| 2 | 10 | Tablette(n) | N04BC05 | 01.08.0. | B |
| 3 | 30 | Tablette(n) | N04BC05 | 01.08.0. | B |
| 4 | 30 | Tablette(n) | N04BC05 | 01.08.0. | B |
| 5 | 30 | Tablette(n) | N04BC05 | 01.08.0. | B |
| 6 | 30 | Tablette(n) | N04BC05 | 01.08.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Pramipexol ER Zentiva 0.375 mg authorised in Switzerland?
Yes. Pramipexol ER Zentiva 0.375 mg is authorised by Swissmedic under authorisation number 65878, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Pramipexol ER Zentiva 0.375 mg have?
Pramipexol ER Zentiva 0.375 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 Pramipexol ER Zentiva 0.375 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.