Ireland· IE-PA-EU/1/18/1325/001-004
Namuscla 167 mg hard capsules
A mexiletine product containing mexiletine hydrochloride, registered in Ireland by Lupin Europe GmbH. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Mexiletine is registered in 13 of 19 countries.
Countries holding a registration under ATC C01BB02 (mexiletine), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Mexiletine · ATC C01BB02
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Japan
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of mexiletine costs, country by country.
Normalised to the WHO defined daily dose (0.8 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Mexiletine · price per daily dose (0.8 g)
USD · FX 28 Sept 2026
- US United States$1.19 (acquisition cost)
The record
At a glance
HPRA (Ireland)- Active substance
- Mexiletine hydrochloride
- Manufacturer
- Lupin Europe GmbH
- Country
- Ireland (IE)
- ATC code
- C01BB02
- ATC class
- Mexiletine
- Defined daily dose
- 0.8 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/18/1325/001-004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
134 interactions on record for mexiletine.
Graded by severity as the source publishes them — 7 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
Mexiletine · interactions on record
134 records
- 7 severe
- 70 moderate
- 5 minor
- 52 info
Most severe, free to view
- TheophyllinC01EB28severe
- BupropionN06AX12severe
- BupropionN07BA02severe
- TheophyllineR03DA04severe
- 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
Mexiletine in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomMexiletine hydrochloride 200mg (Mexiletine 167mg) capsulesColonis Pharma Ltd
- CzechiaNAMUSCLALupin Europe GmbH, Frankfurt am Main
- FinlandNamusclaLupin Europe GmbH
- FranceNAMUSCLA 167 mg, gélulesLUPIN EUROPE (ALLEMAGNE)
- IcelandNamusclaLupin Europe GmbH
- NetherlandsNamuscla 167 mg harde capsulesLupin (Europe) Limited
- NorwayNamusclaLupin (Europe) Limited
- PolandNamusclaLupin Europe GmbH
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Germany · Zunmyro, Zunmyro 200 Mg Hartkapseln
- Denmark · Dopital
- Finland · Dopital
- France · Makmorsa
- United Kingdom (Northern Ireland) · Mexiletine Hydrochloride Clinigen Healthcare, Mexiletine Hydrochloride Waymade
- Hungary · Ritalmex
- Norway · Dopital
- Sweden · Dopital
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/728fa6cb-0fdc-4afa-b787-049ba02d2aa3 GET /v1/drugs/728fa6cb-0fdc-4afa-b787-049ba02d2aa3?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, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"C01BB02"
],
"strength": null,
"pa_number": "EU/1/18/1325/001-004",
"substances": [
"Mexiletine hydrochloride"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "18/12/2018",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about mexiletine.
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.