Poland· PL-100191043
Nalpain 10 mg/ml
A nalbuphine product containing nalbuphini hydrochloridum, registered in Poland by Orpha-Devel Handels und Vertriebs GmbH. The same ATC class is registered in 11 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Nalbuphine is registered in 11 of 19 countries.
Countries holding a registration under ATC N02AF02 (nalbuphine), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 7 of them publish a price we can compare per daily dose
Nalbuphine · ATC N02AF02
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Finlandprice
- Franceprice
- Germany
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
URPL (Poland)- Active substance
- Nalbuphini hydrochloridum
- Manufacturer
- Orpha-Devel Handels und Vertriebs GmbH
- Country
- Poland (PL)
- ATC code
- N02AF02
- ATC class
- Nalbuphine
- Defined daily dose
- 80 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909990639410
- gtin04150011382261
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
148 interactions on record for nalbuphine.
Graded by severity as the source publishes them — 18 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
Nalbuphine · interactions on record
148 records
- 18 severe
- 98 moderate
- 32 info
Most severe, free to view
- AlvimopanA06AH02severe
- OpiumA07DA02severe
- ChlorphenesinD01AE07severe
- ChlorphenesinG01AX21severe
- 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
Nalbuphine in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumPainafin 10 mg/mlOrpha-Devel Handels und Vertriebs
- CzechiaNALBUPHIN ORPHAOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- FinlandNalpainOrpha-Devel Handels und Vertriebs GmbH
- NetherlandsNalbufine HCl Orpha 10 mg/ml oplossing voor injectieOrpha Devel Handels-und Vertriebs GmbH
- United StatesNALBUPHINE HCIHF Acquisition Co LLC, DBA HealthFirst
- United KingdomNalbuphine 20mg/2ml solution for injection ampoulesImported (Austria)
- GermanyNalpainOrpha-Devel Handels Und Vertriebs Gmbh
- FranceNALBUPHINE RENAUDIN 20 mg/2 mL, solution injectableLABORATOIRE RENAUDIN
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Austria · Nalbuphin Amomed, Nubain
- Czechia · Nalbuphin Orpha
- Germany · Nalpain, Nubain
- France · Nalbuphine Renaudin, Nalbuphine Serb
- Greece · Nalpain
- Hungary · Nalpain
- Netherlands · Nalbufine Hcl Orpha
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/5862d341-2e0d-4845-b8df-6d9d5616ccc3 GET /v1/drugs/5862d341-2e0d-4845-b8df-6d9d5616ccc3?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 wstrzykiwań",
"source": "urpl",
"strength": "10 mg/ml",
"packaging": "05909990639410 ¦ Rpw ¦ 42652\n10 amp. 2 ml\n¦ UR/Z/4c/320/25 - 04150011382261",
"substance": "Nalbuphini hydrochloridum 10 mg/ml",
"common_name": "Nalbuphini hydrochloridum",
"pl_product_id": "100191043",
"pozwolenie_nr": "14424",
"auth_procedure": "MRP",
"authorisation_validity": "Bezterminowe"
}See everything about nalbuphine.
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.