Ireland· IE-PA-EU/1/14/979/001-002
Ofev 100 mg Soft capsule
A nintedanib product containing nintedanib, registered in Ireland by Boehringer Ingelheim International GmbH.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Nintedanib
- Manufacturer
- Boehringer Ingelheim International GmbH
- Country
- Ireland (IE)
- ATC code
- L01XE31
- ATC class
- Nintedanib
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/979/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
160 interactions on record for nintedanib.
Graded by severity as the source publishes them — 21 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
Nintedanib · interactions on record
160 records
- 21 severe
- 139 moderate
Most severe, free to view
- MipomersenC10AX11severe
- LomitapideC10AX12severe
- DexamethasoneH02AB02severe
- RifampicinJ04AB02severe
- 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
Nintedanib in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IcelandAgarfNorameda UAB
- SpainNINTEDANIB ACCORD 100 MG CAPSULAS BLANDAS EFGAccord Healthcare S.L.U.
- SwedenNintedanib Accord 100 mg Kapsel, mjukAccord Healthcare S.L.U.
- PolandNintedanib AccordAccord Healthcare S.L.U.
- FranceNINTEDANIB ACCORD 100 mg, capsule molleACCORD HEALTHCARE (ESPAGNE)
- SwitzerlandNintedanib Leman 100 mg, capsule molleLeman SKL SA
- NorwayNintedanib AccordAccord Healthcare S.L.
- NetherlandsGevesla 100 mg, zachte capsulesSandoz B.V.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Nintedanib Cipla, Nintedanib Ratiopharm
- Belgium · Nintedanib Accordpharma, Nintedanib Eg
- Cyprus · Nintedanib Teva
- Czechia · Nintedanib Glenmark, Nintedanib Sandoz
- Germany · Nintedanib, Nintedanib 1 A Pharma
- Denmark · Nintedanib "sandoz", Nintedanib Glenmark
- Estonia · Agarf, Nintedanib Sandoz
- Spain · Nintedanib, Nintedanib Accordpharma
- Finland · Nintedanib Glenmark, Nintedanib Ratiopharm
- France · Nintedanib Arrow, Nintedanib Biogaran
- United Kingdom (Northern Ireland) · Nintedanib, Nintedanib Accord Healthcare
- Greece · Nifib, Nindraf
- Croatia · Gevesla, Nintedanib Accordpharma
- Hungary · Nintedanib Accordpharma, Nintedanib Onkogen
- Iceland · Agarf, Nintedanib Accord
- Italy · Nintedanib Accordpharma, Nintedanib Aurobindo
- Liechtenstein · Nintedanib Accord, Nintedanib Viatris
- Lithuania · Agarf, Nintedanib Sandoz
- Luxembourg · Nintedanib Eg, Nintedanib Eurogenerics
- Latvia · Agarf, Nintedanib Sandoz
- Malta · Nifiden Adalvo, Nintedanib Adalvo
- Netherlands · Gevesla, Nintedanair
- Norway · Nintedanib Accord, Nintedanib Devatis
- Poland · Nintedanib, Nintedanib Accordpharma
- Portugal · Nintedanib Accordpharma, Nintedanib Eugia
- Romania · Gevesla, Nintedanib Dr. Reddy’s
- Sweden · Nintedanib Devatis, Nintedanib Glenmark
- Slovenia · Nintedanib Accordpharma, Nintedanib Stada
- Slovakia · Nintedanib Stada, Nintedanib Teva
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 HPRA (Ireland). 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/c9aa1211-4cec-4ade-8d52-eebcc1e53a62 GET /v1/drugs/c9aa1211-4cec-4ade-8d52-eebcc1e53a62?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": "Capsule, soft",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"L01XE",
"L01XE31"
],
"strength": null,
"pa_number": "EU/1/14/979/001-002",
"substances": [
"Nintedanib"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "15/01/2015",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0206-024-001"
}See everything about nintedanib.
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.