Quetiapin XR Zentiva 50mg
Quetiapin XR Zentiva 50mg is a medicine authorised by Swissmedic under authorisation number 66081. 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 20 April 2017 and the authorisation is valid without a time limit. ATC code N05AH04 places the medicine in the group Psycholeptics.
| Authorisation number | 66081 |
|---|---|
| Name | Quetiapin XR Zentiva 50mg |
| Full name | Quetiapin XR Zentiva 50mg, Retardtabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N05AH04 |
| First authorisation | 20 April 2017 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Quetiapin XR Zentiva 50mg, Retardtabletten | B | 20 April 2017 |
| 2 | Quetiapin XR Zentiva 150mg, Retardtabletten | B | 20 April 2017 |
| 3 | Quetiapin XR Zentiva 200mg, Retardtabletten | B | 20 April 2017 |
| 4 | Quetiapin XR Zentiva 300mg, Retardtabletten | B | 20 April 2017 |
| 5 | Quetiapin XR Zentiva 400mg, Retardtabletten | B | 20 April 2017 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 60 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 3 | 60 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 5 | 100 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 6 | 60 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 8 | 100 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 9 | 60 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 11 | 100 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 12 | 60 | Tablette(n) | N05AH04 | 01.05.0. | B |
| 14 | 100 | Tablette(n) | N05AH04 | 01.05.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Quetiapin XR Zentiva 50mg authorised in Switzerland?
Yes. Quetiapin XR Zentiva 50mg is authorised by Swissmedic under authorisation number 66081, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Quetiapin XR Zentiva 50mg have?
Quetiapin XR Zentiva 50mg 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 Quetiapin XR Zentiva 50mg?
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.