Sweden· SE-20250310000045
Namuscla 83 mg Kapsel, hård
A medicinal product containing mexiletine, registered in Sweden by Lupin Europe GmbH.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Mexiletine
- Manufacturer
- Lupin Europe GmbH
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20250310000045
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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 100mg (Mexiletine 83mg) capsulesSovereign Medical Ltd
- CzechiaNAMUSCLALupin Europe GmbH, Frankfurt am Main
- BelgiumNamuscla 83 mgLupin Europe
- FinlandNamusclaLupin Europe GmbH
- United StatesMexiletine hydrochlorideCamber Pharmaceuticals, Inc.
- NorwayDopitalMacure Pharma ApS
- CanadaMINT-MEXILETINEMINT PHARMACEUTICALS INC
- IcelandNamusclaLupin Europe GmbH
Authorised across Europe · EMA
The same active substance is authorised in 7 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
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 Swedish Medical Products Agency (Sweden). 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/feb90244-51ea-47a6-9c71-97678ddfd95b GET /v1/drugs/feb90244-51ea-47a6-9c71-97678ddfd95b?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EPAR",
"EMA"
],
"se_npl_id": "20250310000045",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20250310000045",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/namuscla-epar-product-information_sv.pdf"
}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.