Isotretinoin Sandoz 5mg

Isotretinoin Sandoz 5mg is a medicine authorised by Swissmedic under authorisation number 68109. The authorisation holder is Sandoz Pharmaceuticals AG. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 15 November 2021 and the authorisation is valid without a time limit. ATC code D10BA01 places the medicine in the group Anti-acne preparations.

  • Dispensing category A
  • Authorisation number 68109
  • ATC D10BA01
  • Synthetic medicines
Authorisation data
Authorisation number68109
NameIsotretinoin Sandoz 5mg
Full nameIsotretinoin Sandoz 5mg, Weichkapseln
Authorisation holderSandoz Pharmaceuticals AG
Medicinal product codeSynthetic medicines
Dispensing categoryA · Prescription, not repeatable
ATC codeD10BA01
First authorisation15 November 2021
Authorisation validityunlimited
Strengths
No.NameDispensing categoryAuthorisation date
1Isotretinoin Sandoz 5mg, WeichkapselnA15 November 2021
2Isotretinoin Sandoz 10mg, WeichkapselnA15 November 2021
3Isotretinoin Sandoz 20mg, WeichkapselnA15 November 2021

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
130Kapsel(n)D10BA0110.02.0.A
2100Kapsel(n)D10BA0110.02.0.A
330Kapsel(n)D10BA0110.02.0.A
4100Kapsel(n)D10BA0110.02.0.A
530Kapsel(n)D10BA0110.02.0.A
6100Kapsel(n)D10BA0110.02.0.A

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Medicines in the same ATC group

Other medicines from this authorisation holder

Frequently asked questions

Is Isotretinoin Sandoz 5mg authorised in Switzerland?

Yes. Isotretinoin Sandoz 5mg is authorised by Swissmedic under authorisation number 68109, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does Isotretinoin Sandoz 5mg have?

Isotretinoin Sandoz 5mg is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.

Who is the authorisation holder of Isotretinoin Sandoz 5mg?

The authorisation holder is Sandoz Pharmaceuticals 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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