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Germany· DE-A57-5a477374eea52397

Ibandronsäure Onkovis

A medicinal product containing ibandronate sodium monohydrate, registered in Germany by Onkovis Gmbh.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedIbandronsäure OnkovisATC—REGISTER NO.DE-A57-5a477374eea523…PACKS LISTED0CHECKEDSeptember 30, 2026

The record

At a glance

EMA Article 57 (European Union)
Active substance
Ibandronate Sodium Monohydrate
Manufacturer
Onkovis Gmbh
Country
Germany (DE)
ATC code
—
Reimbursed
Not published by this register
Source register
EMA Article 57 (European Union)
Last checked
September 30, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Ibandronate sodium monohydrate in 7 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All ibandronate sodium monohydrate products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Austria · Ibandronsäure +pharma, Ibandronsäure Actavis
  • Czechia · Ibandronic Acid Viatris
  • Finland · Ibandronate Ratiopharm
  • United Kingdom (Northern Ireland) · Ibandronic Acid Noridem Enterprises
  • Greece · Ibondem
  • Croatia · Ostea
  • Hungary · Bonessa, Etanorden
  • Ireland · Ibandronic Acid Noridem Enterprises
  • Iceland · Ibandronic Acid Wh
  • Italy · Acido Ibandronico Mylan
  • Latvia · Ossica
  • Netherlands · Ibandroninezuur Synthon
  • Poland · Ibandronic Acid Noridem, Osagrand
  • Portugal · Ácido Ibandrónico Gedeon Richter
  • Romania · Ossica
  • Sweden · Ibandronate Bluefish
  • Slovakia · Ossica

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of EMA Article 57 (European Union). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/4ab0a00f-60e7-406b-89d4-8dbe25eb4142
GET /v1/drugs/4ab0a00f-60e7-406b-89d4-8dbe25eb4142?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "pzn": null,
  "route": "Intravenous Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Ibandronate Sodium Monohydrate",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about ibandronate sodium monohydrate.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.