Poland· PL-100439135
Zolgensma
A onasemnogene abeparvovec product containing onasemnogenum abeparvovecum, registered in Poland by Novartis Europharm Limited. The same ATC class is registered in 14 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
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: Poland, from URPL (Poland)
- 9 of them publish a price we can compare per daily dose
Onasemnogene abeparvovec · ATC M09AX09
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
URPL (Poland)- Active substance
- Onasemnogenum abeparvovecum
- Manufacturer
- Novartis Europharm Limited
- Country
- Poland (PL)
- ATC code
- M09AX09
- ATC class
- Onasemnogene abeparvovec
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 37
- gtin05397227704923
- gtin05397227704954
- gtin05397227704985
- gtin05397227705012
- gtin05397227701083
- gtin05397227701106
- gtin05397227701137
- gtin05397227701168
- gtin05397227701199
- gtin05397227702844
- gtin05397227702875
- gtin05397227702905
- gtin05397227704886
- gtin05397227704916
- gtin05397227704947
- gtin05397227704978
- gtin05397227705005
- gtin05397227701090
- gtin05397227701120
- gtin05397227701151
- gtin05397227701182
- gtin05397227702837
- gtin05397227704879
- gtin05397227702868
- gtin05397227702899
- gtin05397227704930
- gtin05397227704961
- gtin05397227704992
- gtin05397227704909
- gtin05397227701113
- gtin05397227701144
- gtin05397227702851
- gtin05397227701175
- gtin05397227702820
- gtin05397227702882
- gtin05397227702912
- gtin05397227704893
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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
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.
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.
- United StatesITVISMANovartis Innovative Technologies Inc.
- CzechiaITVISMANovartis Europharm Limited, Dublin
- BelgiumItvisma 1.2 10*14 vgNovartis Europharm
- United KingdomZolgensma 20 tera vector genomes/ml (patient weight 10.1-10.5kg) solution for infusion 7 x 8.3ml vialsNovartis Pharmaceuticals UK Ltd
- NetherlandsItvisma 1,2 × 1014 vectorgenomen oplossing voor injectieNovartis Europharm Limited
- FinlandItvismaNovartis Europharm Limited
- SwedenItvisma 1,2 x 10E14 vektorgenom Injektionsvätska, lösningNovartis Europharm Limited
- Japanオナセムノゲン アベパルボベクノバルティス ファーマ
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 URPL (Poland). 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/b2076ef6-6492-4090-91c5-2cae17f84433 GET /v1/drugs/b2076ef6-6492-4090-91c5-2cae17f84433?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.
{
"form": "Roztwór do infuzji",
"source": "urpl",
"strength": "2 x 10¹³ vg/ml",
"packaging": "05397227701083 ¦ Rpz ¦ EU/1/20/1443/001 ¦ 137224\n2 fiol. 8,3 ml\n05397227701106 ¦ Rpz ¦ EU/1/20/1443/003 ¦ 137841\n1 fiol. 5,5 ml ¦ 2 fiol. 8,3 ml\n05397227701137 ¦ Rpz ¦ EU/1/20/1443/006 ¦ 137843\n1 fiol. 5,5 ml ¦ 3 fiol. 8,3 ml\n05397227701168 ¦ Rpz ¦ EU/1/20/1443/009 ¦ 137844\n1 fiol. 5,5 ml ¦ 4 fiol. 8,3 ml\n05397227701199 ¦ Rpz ¦ EU/1/20/1443/012 ¦ 137845\n1 fiol. 5,5 ml ¦ 5 fiol. 8,3 ml\n05397227702844 ¦ Rpz ¦ EU/1/20/1443/015 ¦ 137846\n1 fiol. 5,5 ml ¦ 6 fiol. 8,3 ml\n05397227702875 ¦ Rpz ¦ EU/1/20/1443/018 ¦ 137847\n1 fiol. 5,5 ml ¦ 7 fiol. 8,3 ml\n05397227702905 ¦ Rpz ¦ EU/1/20/1443/021 ¦ 137848\n1 fiol. 5,5 ml ¦ 8 fiol. 8,3 ml\n05397227704886 ¦ Rpz ¦ EU/1/20/1443/024 ¦ 137849\n1 fiol. 5,5 ml ¦ 9 fiol. 8,3 ml\n05397227704916 ¦ Rpz ¦ EU/1/20/1443/027 ¦ 137850\n1 fiol. 5,5 ml ¦ 10 fiol. 8,3 ml\n05397227704947 ¦ Rpz ¦ EU/1/20/1443/030 ¦ 137851\n1 fiol. 5,5 ml ¦ 11 fiol. 8,3 ml\n05397227704978 ¦ Rpz ¦ EU/1/20/1443/033 ¦ 137852\n1 fiol. 5,5 ml ¦ 12 fiol. 8,3 ml\n05397227705005 ¦ Rpz ¦ EU/1/20/1443/036 ¦ 137853\n1 fiol. 5,5 ml ¦ 13 fiol. 8,3 ml\n05397227701090 ¦ Rpz ¦ EU/1/20/1443/002 ¦ 137854\n2 fiol. 5,5 ml ¦ 1 fiol. 8,3 ml\n05397227701120 ¦ Rpz ¦ EU/1/20/1443/005 ¦ 137855\n2 fiol. 5,5 ml ¦ 2 fiol. 8,3 ml\n05397227701151 ¦ Rpz ¦ EU/1/20/1443/008 ¦ 137856\n2 fiol. 5,5 ml ¦ 3 fiol. 8,3 ml\n05397227701182 ¦ Rpz ¦ EU/1/20/1443/011 ¦ 137857\n2 fiol. 5,5 ml ¦ 4 fiol. 8,3 ml\n05397227702837 ¦ Rpz ¦ EU/1/20/1443/014 ¦ 137858\n2 fiol. 5,5 ml ¦ 5 fiol. 8,3 ml\n05397227704879 ¦ Rpz ¦ EU/1/20/1443/023 ¦ 137859\n2 fiol. 5,5 ml ¦ 8 fiol. 8,3 ml\n05397227702868 ¦ Rpz ¦ EU/1/20/1443/017 ¦ 137860\n2 fiol. 5,5 ml ¦ 5 fiol. 8,3 ml\n05397227702899 ¦ Rpz ¦ EU/1/20/1443/020 ¦ 137861\n2 fiol. 5,5 ml ¦ 7 fiol. 8,3 ml\n05397227704930 ¦ Rpz ¦ EU/1/20/1443/029 ¦ 137862\n2 fiol. 5,5 ml ¦ 10 fiol. 8,3 ml\n05397227704961 ¦ Rpz ¦ EU/1/20/1443/032 ¦ 137863\n2 fiol. 5,5 ml ¦ 11 fiol. 8,3 ml\n05397227704992 ¦ Rpz ¦ EU/1/20/1443/035 ¦ 137864\n2 fiol. 5,5 ml ¦ 12 fiol. 8,3 ml\n05397227704909 ¦ Rpz ¦ EU/1/20/1443/026 ¦ 137865\n2 fiol. 5,5 ml ¦ 9 fiol. 8,3 ml\n05397227701113 ¦ Rpz ¦ EU/1/20/1443/004 ¦ 137866\n3 fiol. 8,3 ml\n05397227701144 ¦ Rpz ¦ EU/1/20/1443/007 ¦ 137867\n4 fiol. 8,3 ml\n05397227702851 ¦ Rpz ¦ EU/1/20/1443/016 ¦ 137868\n7 fiol. 8,3 ml\n05397227701175 ¦ Rpz ¦ EU/1/20/1443/010 ¦ 137869\n5 fiol. 8,3 ml\n05397227702820 ¦ Rpz ¦ EU/1/20/1443/013 ¦ 137870\n6 fiol. 8,3 ml\n05397227702882 ¦ Rpz ¦ EU/1/20/1443/019 ¦ 137871\n8 fiol. 8,3 ml\n05397227702912 ¦ Rpz ¦ EU/1/20/1443/022 ¦ 137872\n9 fiol. 8,3 ml\n05397227704893 ¦ Rpz ¦ EU/1/20/1443/025 ¦ 137873\n10 fiol. 8,3 ml\n05397227704923 ¦ Rpz ¦ EU/1/20/1443/028 ¦ 137874\n11 fiol. 8,3 ml\n05397227704954 ¦ Rpz ¦ EU/1/20/1443/031 ¦ 137875\n12 fiol. 8,3 ml\n05397227704985 ¦ Rpz ¦ EU/1/20/1443/034 ¦ 137876\n13 fiol. 8,3 ml\n05397227705012 ¦ Rpz ¦ EU/1/20/1443/037 ¦ 137877\n14 fiol. 8,3 ml",
"substance": "Onasemnogenum abeparvovecum 2 x 10¹³ vg/ml",
"common_name": "Onasemnogenum abeparvovecum",
"pl_product_id": "100439135",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.