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.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
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
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_id113796
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.
- SpainPASANG 425 mg COMPRIMIDOS RECUBIERTOSPascoe Pharmazeutische Praeparate Gmbh
- BelgiumPassiflora Incarnata Boiron 30KBoiron
- SwitzerlandSidroga Beruhigungstee, ArzneiteeUriach Switzerland AG
- NorwayPascoflairPASCOE pharmazeutische Präparate GmbH
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.