Belgium· BE-AMP-SAM517386-00
Navalit 10 mg - 10 mg
A doxylamin, kombinationen (auch als sedativum) product containing doxylamine hydrogen succinate, registered in Belgium by EFFIK Benelux. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Doxylamin, kombinationen (auch als sedativum) is registered in 12 of 19 countries.
Countries holding a registration under ATC R06AA59 (doxylamin, kombinationen (auch als sedativum)), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 8 of them publish a price we can compare per daily dose
Doxylamin, kombinationen (auch als sedativum) · ATC R06AA59
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Statesprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Doxylamine Hydrogen Succinate
- Manufacturer
- EFFIK Benelux
- Country
- Belgium (BE)
- ATC code
- R06AA59
- ATC class
- Doxylamin, Kombinationen (auch als Sedativum)
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb3893658
- be_apb4557823
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Doxylamin, kombinationen (auch als sedativum) in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesBasic Care Sleep AidAmazon.com Services LLC
- SpainDORMIDINA DOXILAMINA 12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULAEsteve Pharmaceuticals S.A.
- PolandBenosenSTADA Arzneimittel AG
- FranceDONORMYL 15 mg, comprimé effervescent sécableUPSA
- GermanyDolginox SchlaftropfenDr. Theiss Naturwaren Gmbh
- NorwayDormidina doxilaminaEsteve Pharmaceuticals S.A
- FinlandDormixOrion Corporation
- NetherlandsDoxylamine Geiser Pharma 12,5 mg poeder voor oraal gebruikGeiser Pharma S.L.
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Hoggar Night
- Cyprus · Hoggar Night
- Germany · Dolginox Schlaftropfen, Doxylamin Dexcel
- Spain · Dormidina, Dormigen
- Finland · Dormix
- France · Donormyl, Doxylamine Arrow Conseil
- Greece · Hoggar Night
- Croatia · Hoggar
- Hungary · Hoggar
- Malta · Doxylamine Krka, Normodorm
- Norway · Zonat
- Poland · Benosen, Doksylamina Geiser
- Portugal · Dormidina, Hoggar
- Slovenia · Noctiben Mea
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 FAMHP / AFMPS (Belgium). 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/85341732-5de4-4deb-aa77-1306fe3508b5 GET /v1/drugs/85341732-5de4-4deb-aa77-1306fe3508b5?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": "Modified-release capsule, hard",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Navalit 10 mg - 10 mg",
"name_fr": "Navalit 10 mg - 10 mg",
"name_nl": "Navalit 10 mg - 10 mg",
"amp_code": "SAM517386-00",
"strengths": [
"10.0000",
"10.0000",
"79.5000"
],
"pack_count": 12,
"substances": [
"Doxylamine Hydrogen Succinate",
"Pyridoxine Hydrochloride",
"Sugar Spheres"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Doxylamine, Combinations",
"authorisation_numbers": [
"BE517386"
]
}See everything about doxylamin, kombinationen (auch als sedativum).
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.