Dabigatran Zentiva 75 mg

Dabigatran Zentiva 75 mg is a medicine authorised by Swissmedic under authorisation number 68728. 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 07 March 2024 and the authorisation is limited until 06 March 2029. The export lists no ATC code for this medicine.

  • Dispensing category B
  • Authorisation number 68728
  • Synthetic medicines
Authorisation data
Authorisation number68728
NameDabigatran Zentiva 75 mg
Full nameDabigatran Zentiva 75 mg, Hartkapseln
Authorisation holderHelvepharm AG
Medicinal product codeSynthetic medicines
Dispensing categoryB · Prescription only
ATC codenot stated
First authorisation07 March 2024
Authorisation validity06 March 2029
Strengths
No.NameDispensing categoryAuthorisation date
1Dabigatran Zentiva 75 mg, HartkapselnB07 March 2024
2Dabigatran Zentiva 110 mg, HartkapselnB07 March 2024
3Dabigatran Zentiva 150 mg, HartkapselnB07 March 2024

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
The Swissmedic export lists no pack sizes for this medicine.

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Other medicines from this authorisation holder

Frequently asked questions

Is Dabigatran Zentiva 75 mg authorised in Switzerland?

Yes. Dabigatran Zentiva 75 mg is authorised by Swissmedic under authorisation number 68728, data as of 01 September 2026. The authorisation is limited until 06 March 2029.

Which dispensing category does Dabigatran Zentiva 75 mg have?

Dabigatran Zentiva 75 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 Dabigatran Zentiva 75 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.

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