United States· US:71894-200_ab2e1c6c-4f95-4243-9296-1734e0a30591

ITVISMA

A onasemnogene abeparvovec product containing onasemnogene abeparvovec-brve, registered in United States by Novartis Gene Therapies, Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC M09AX09US label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about onasemnogene abeparvovec-brveAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Onasemnogene abeparvovec is registered in 14 of 19 countries.

Countries holding a registration under ATC M09AX09 (onasemnogene abeparvovec), each read from that country’s own register.

This record: United States, from FDA National Drug Code directory (United States)
9 of them publish a price we can compare per daily dose

Search onasemnogene abeparvovec products by name

Onasemnogene abeparvovec · ATC M09AX09

14 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Franceprice
Icelandprice
Ireland
Netherlands
Norwayprice
Polandprice
Switzerlandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: onasemnogene abeparvovec-brve
Manufacturer: Novartis Gene Therapies, Inc.
Country: United States (US)
ATC code: M09AX09
ATC class: Onasemnogene abeparvovec
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 1

ndc11
7189420002
1 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01)

Regulatory notes

UNII (FDA substance ID)

MLU3LU3EVV

ONASEMNOGENE ABEPARVOVEC

RxCUI 2170226

DailyMed SPL labels

1 version tracked

Interactions

19 interactions on record for onasemnogene abeparvovec.

Graded by severity as the source publishes them — 4 severe. Severity grades are free for everyone; mechanism and management come with Growth.

Severity for every pair — free, no plan needed
The source, licence and sync date on every record
Mechanism and what to do for each pair — Growth plan

Check onasemnogene abeparvovec against other medicines How interaction checks work

Onasemnogene abeparvovec · interactions on record

19 records

4 severe
15 moderate

Most severe, free to view

LeflunomidL04AA13severe
TeriflunomidL04AA31severe
LeflunomideL04AK01severe
TeriflunomideL04AK02severe

Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.

Mechanism and what to do, in the interaction check

Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Onasemnogene abeparvovec in 14 other countries

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

All onasemnogene abeparvovec products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

Iceland · Itvisma, Zolgensma
Liechtenstein · Itvisma, Zolgensma
Norway · Itvisma, Zolgensma

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 FDA National Drug Code directory (United States). 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/7a5a9958-cccf-4995-8e08-8e435d495442
GET /v1/drugs/7a5a9958-cccf-4995-8e08-8e435d495442?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.

{
  "unii": {
    "unii": "MLU3LU3EVV",
    "rxcui": "2170226",
    "inchikey": null,
    "display_name": "ONASEMNOGENE ABEPARVOVEC",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRATHECAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 4
  },
  "spl_meta": {
    "ab2e1c6c-4f95-4243-9296-1734e0a30591": {
      "match": "brand_token",
      "title": "ITVISMA (ONASEMNOGENE ABEPARVOVEC-BRVE) INJECTION, SUSPENSION [NOVARTIS GENE THERAPIES, INC.]",
      "spl_version": "1",
      "published_date": "2025-11-27"
    }
  },
  "productid": "71894-200_ab2e1c6c-4f95-4243-9296-1734e0a30591",
  "productndc": "71894-200",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONASEMNOGENE ABEPARVOVEC",
  "proprietary_name": "ITVISMA",
  "active_ingred_unit": "[arb'U]/mL",
  "application_number": "BLA125856",
  "marketing_category": "BLA",
  "nonproprietary_name": "onasemnogene abeparvovec-brve",
  "start_marketing_date": "20251124",
  "active_numerator_strength": "40000000000000"
}

API reference MCP server Plans

See everything about onasemnogene abeparvovec.

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.

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