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Netherlands· NL-bd65095db370

Sofytol omhulde tabletten

A other hypnotics and sedatives product containing passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1), registered in Netherlands by Tilman s.a.. The same ATC class is registered in 7 of our 19 countries.

ATC N05CM

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedSofytol omhulde tablettenATCN05CMREGISTER NO.NL-bd65095db370PACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1) is registered in 7 of 19 countries.

Countries holding a registration under ATC N05CM (other hypnotics and sedatives), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 4 of them publish a price we can compare per daily dose

Passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1) · ATC N05CM

7 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
PASSIFLORAE INCARNATA HERBA DROOG ETHANOLISCH (60 pCt.) EXTRACT (3,5-5 = 1)
Manufacturer
Tilman s.a.
Country
Netherlands (NL)
ATC code
N05CM
ATC class
Other hypnotics and sedatives
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    113796

Regulatory notes

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

Same medicine, other countries

Passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1) in 4 other countries

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

All passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1) products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Spain · Pasinat

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 CBG-MEB (Netherlands). 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/8b5d71cb-2de0-49a5-88fd-57d97bf6228f
GET /v1/drugs/8b5d71cb-2de0-49a5-88fd-57d97bf6228f?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": "Omhulde tablet",
  "route": "Oraal gebruik",
  "soort": "RVG",
  "source": "cbg_meb",
  "smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h113796_smpc.pdf",
  "strength": null,
  "atc_label": "Other Hypnotics And Sedatives",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg113796",
  "excipients": [
    "CALCIUMCARBONAAT (E 170)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "KARMIJN (E120)",
    "MACROGOL 3350",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MALTODEXTRINE",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "POLYVINYLALCOHOL (E 1203)",
    "SILICIUMDIOXIDE (E 551)",
    "TALK (E 553b)"
  ],
  "substances": [
    "PASSIFLORAE INCARNATA HERBA DROOG ETHANOLISCH  (60 pCt.) EXTRACT (3,5-5 = 1)"
  ],
  "leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h113796.pdf",
  "authorised_at": "2014/01/30",
  "procedure_number": "BE/H/0175/001",
  "dispensing_status": "Uitsluitend apotheek of drogist",
  "registration_number": "113796",
  "additional_monitoring": "N"
}

See everything about passiflorae incarnata herba droog ethanolisch (60 pct.) extract (3,5-5 = 1).

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.