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Sweden· SE-19631018000072

Saroten 10 mg Filmdragerad tablett

A medicinal product containing amitriptyline hydrochloride, registered in Sweden by H. Lundbeck A/S.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedSaroten 10 mg Filmdragerad tablettATC—REGISTER NO.SE-19631018000072PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Amitriptyline Hydrochloride
Manufacturer
H. Lundbeck A/S
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
    19631018000072

Regulatory notes

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

Same medicine, other countries

Amitriptyline hydrochloride in 16 other countries

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

All amitriptyline hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Saroten
  • Belgium · Redomex
  • Bulgaria · Амитрекс
  • Cyprus · Amirol
  • Czechia · Amitriptylin Slovakofarma
  • Germany · Amineurin, Amineurin Retard
  • Denmark · Amitriptylin "eql Pharma", Amitriptylin Abcur
  • Estonia · Amitriptyline Grindeks
  • Spain · Amitriptilina Hidrocloruro Tarbis, Deprelio
  • Finland · Amitriptylin Abcur, Triptyl
  • France · Amitriptyline Biogaran, Amitriptyline Gerda
  • United Kingdom (Northern Ireland) · Amitriptyline, Amitriptyline Accord
  • Croatia · Amitriptilin Sandoz
  • Hungary · Teperinep
  • Ireland · Amitriptyline Clonmel Healthcare, Amitriptyline Hydrochloride Pinewood Laboratories
  • Iceland · Amitriptylin Abcur
  • Italy · Adepril, Amitriptilina Doc
  • Lithuania · Amitriptyline Grindeks, Amitriptylinum Viatris
  • Luxembourg · Amitriptylin Micro Labs, Redomex
  • Latvia · Amitriptyline Grindeks
  • Malta · Amirol, Amitriptyline Accord Healthcare
  • Netherlands · Amitriptyline Bb, Amitriptyline Expharma
  • Norway · Amitriptylin Abcur, Amitriptylin Orifarm
  • Poland · Amitriptylinum Vp
  • Portugal · Adt
  • Romania · Amitriptilină Arena
  • Slovenia · Amyzol
  • Slovakia · Amitriptylin Slovakofarma

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/b444ae18-cdbe-4f4c-962c-3e9cae4f8178
GET /v1/drugs/b444ae18-cdbe-4f4c-962c-3e9cae4f8178?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": "19631018000072",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=19631018000072",
  "product_doc_link": "https://docetp.mpa.se/LMF/Saroten%20film-coated%20tablet%20SmPC_09001bee807a6b64.pdf"
}

See everything about amitriptyline 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.