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Sweden· SE-20210608000041

Dopital 100 mg Kapsel, hård

A medicinal product containing mexiletine hydrochloride, registered in Sweden by MACURE PHARMA ApS.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedDopital 100 mg Kapsel, hårdATC—REGISTER NO.SE-20210608000041PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Mexiletine Hydrochloride
Manufacturer
MACURE PHARMA ApS
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_varunummer
    20210608000041

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Mexiletine hydrochloride in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mexiletine hydrochloride products

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/18726e41-a4a1-4b76-ac53-e4e081944f55
GET /v1/drugs/18726e41-a4a1-4b76-ac53-e4e081944f55?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": [
    "PL",
    "SmPC"
  ],
  "se_npl_id": "20210608000041",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20210608000041",
  "product_doc_link": "https://docetp.mpa.se/LMF/Dopital%20capsule%2C%20hard%20SmPC_09001bee82a0fa56.pdf"
}

See everything about mexiletine hydrochloride.

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.