Hydromorphone Mundipharma Retard 4 mg

Hydromorphone Mundipharma Retard 4 mg is a medicine authorised by Swissmedic under authorisation number 70347. The authorisation holder is Mundipharma Regulatory GmbH. The medicinal product code is Synthetic medicines and the dispensing category is A+: Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material. First authorisation was granted on 18 July 2025 and the authorisation is valid without a time limit. ATC code N02AA03 places the medicine in the group Analgesics.

  • Dispensing category A+
  • Authorisation number 70347
  • ATC N02AA03
  • Synthetic medicines
Authorisation data
Authorisation number70347
NameHydromorphone Mundipharma Retard 4 mg
Full nameHydromorphone Mundipharma Retard 4 mg, Retardkapseln
Authorisation holderMundipharma Regulatory GmbH
Medicinal product codeSynthetic medicines
Dispensing categoryA+ · Prescription with conditions
ATC codeN02AA03
First authorisation18 July 2025
Authorisation validityunlimited
Strengths
No.NameDispensing categoryAuthorisation date
1Hydromorphone Mundipharma Retard 4 mg, RetardkapselnA+18 July 2025
2Hydromorphone Mundipharma Retard 8 mg, RetardkapselnA+18 July 2025
3Hydromorphone Mundipharma Retard 16 mg, RetardkapselnA+18 July 2025
4Hydromorphone Mundipharma Retard 24 mg, RetardkapselnA+18 July 2025

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
130Kapsel(n)N02AA0301.01.3.A+
260Kapsel(n)N02AA0301.01.3.A+
330Kapsel(n)N02AA0301.01.3.A+
460Kapsel(n)N02AA0301.01.3.A+
530Kapsel(n)N02AA0301.01.3.A+
660Kapsel(n)N02AA0301.01.3.A+
730Kapsel(n)N02AA0301.01.3.A+
860Kapsel(n)N02AA0301.01.3.A+

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Medicines in the same ATC group

Other medicines from this authorisation holder

Frequently asked questions

Is Hydromorphone Mundipharma Retard 4 mg authorised in Switzerland?

Yes. Hydromorphone Mundipharma Retard 4 mg is authorised by Swissmedic under authorisation number 70347, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does Hydromorphone Mundipharma Retard 4 mg have?

Hydromorphone Mundipharma Retard 4 mg is in dispensing category A+. Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material.

Who is the authorisation holder of Hydromorphone Mundipharma Retard 4 mg?

The authorisation holder is Mundipharma Regulatory GmbH. 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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