Amgevita 40 mg/0.8 ml

Amgevita 40 mg/0.8 ml is a medicine authorised by Swissmedic under authorisation number 67204. The authorisation holder is Amgen Switzerland AG. The medicinal product code is Biotechnological 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 13 September 2019 and the authorisation is valid without a time limit. ATC code L04AB04 places the medicine in the group Immunosuppressants.

  • Dispensing category B
  • Authorisation number 67204
  • ATC L04AB04
  • Biotechnological medicines
Authorisation data
Authorisation number67204
NameAmgevita 40 mg/0.8 ml
Full nameAmgevita 40 mg/0.8 ml, Injektionslösung im Fertigpen
Authorisation holderAmgen Switzerland AG
Medicinal product codeBiotechnological medicines
Dispensing categoryB · Prescription only
ATC codeL04AB04
First authorisation13 September 2019
Authorisation validityunlimited
Strengths
No.NameDispensing categoryAuthorisation date
1Amgevita 40 mg/0.8 ml, Injektionslösung im FertigpenB13 September 2019
2Amgevita 40 mg/0.4 ml, Injektionslösung im FertigpenB22 February 2024
3Amgevita 80 mg/0.8 ml, Injektionslösung im FertigpenB22 February 2024

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
11Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
22Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
36Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
41Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
62Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
76Injektor(en), vorgefüllt/PenL04AB0407.15.0.B
51Injektor(en), vorgefüllt/PenL04AB0407.15.0.B

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Medicines in the same ATC group

Other medicines from this authorisation holder

Frequently asked questions

Is Amgevita 40 mg/0.8 ml authorised in Switzerland?

Yes. Amgevita 40 mg/0.8 ml is authorised by Swissmedic under authorisation number 67204, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does Amgevita 40 mg/0.8 ml have?

Amgevita 40 mg/0.8 ml 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 Amgevita 40 mg/0.8 ml?

The authorisation holder is Amgen Switzerland 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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