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Medicines
Netherlands
Mexiletine

CBG-MEB 2018

Mexiletine

Namuscla 167 mg harde capsules

Capsule, hardNetherlandsAuthorisedAuthorised 18 Dec 2018

Product informationAsk Osler about it

On this page

In other countries
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

NamusclaEuropean UnionAuthorised

Namuscla 167 MG Capsulas DurasSpain · 200 mg · cápsula dura · Lupin Europe GmbhSame brand
Namuscla 62 MG Capsulas DurasSpain · 75 mg · cápsula dura · Lupin Europe GmbhSame brand
Namuscla 83 MG Capsulas DurasSpain · 83 mg · cápsula dura · Lupin Europe GmbhSame brand
NamusclaEuropean Union · Lupin Europe GmbHSame brand
NamusclaCroatiaSame brand
NamusclaItaly · Capsula rigida · Lupin Europe GMBHSame brand

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇨🇦Mint-MexiletineCanada · 100 MG · Capsule · Mint Pharmaceuticals INCSame form

🇨🇦Mint-MexiletineCanada · 200 MG · Capsule · Mint Pharmaceuticals INCSame form

🇨🇦Teva-MexiletineCanada · 200 MG · Capsule · Teva Canada LimitedSame form

🇳🇿TevaNew Zealand · Cap 150 mgSame form

🇳🇿TevaNew Zealand · Cap 250 mgSame form

🇺🇸Mexiletine HydrochlorideUnited States · 150MG, 200MG, 250MG · capsule · Ingenus Pharms LLCSame form

🇺🇸MexitilUnited States · 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule · Boehringer IngelheimSame form

Documents

The official texts, at the regulator.

Summary of product characteristicsCBG-MEB
Register entryCBG-MEB

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Mexiletine
Dosage form: Capsule, hard
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 18 Dec 2018
Registration: EU/1/18/1325
Marketing authorisation holder: Lupin (Europe) Limited
ATC code: M09AX
Group: Musculo-skeletal system
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/004584
EU number: EU/1/18/1325