Belgium· BE-AMP-SAM316985-00
Protamine Sulfaat Leo Pharma 1400 IU/ml
A protamine product containing protamine sulfate, registered in Belgium by Leo Pharma. The same ATC class is registered in 16 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Protamine is registered in 16 of 19 countries.
Countries holding a registration under ATC V03AB14 (protamine), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 10 of them publish a price we can compare per daily dose
Protamine · ATC V03AB14
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Protamine Sulfate
- Manufacturer
- Leo Pharma
- Country
- Belgium (BE)
- ATC code
- V03AB14
- ATC class
- Protamine
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb2755106
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Protamine in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaPROTAMINE SULFATE LEO PHARMALEO Pharma A/S, Ballerup
- FinlandProtamiinisulfaatti Leo PharmaParanova Oy
- United StatesProtamine SulfateFresenius Kabi USA, LLC
- CanadaPROTAMINE SULFATE INJECTION USPSANDOZ CANADA INCORPORATED
- PolandProtamine sulfate LEO PharmaLEO Pharma A/S
- SwedenProtaminsulfat LEO Pharma 1400 anti-heparin IE/ml Injektions-/infusionsvätska, lösningOrifarm AB
- IcelandProtaminsulphat LEO PharmaLEO Pharma A/S*
- NorwayProtaminsulfat LEO PharmaLEO PHARMA (2)
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Protaminsulfat Leo Pharma
- Bulgaria · Паминту
- Czechia · Protamine Sulfate Leo Pharma
- Germany · Protaminsulfat Leo Pharma
- Denmark · Protaminsulfat Leo Pharma
- Estonia · Protamine Sulphate Leo Pharma
- Spain · Protamina Sulfato, Protamina Sulfato Leo Pharma
- Finland · Protaminsulfat Leo Pharma
- France · Protamine Choay
- United Kingdom (Northern Ireland) · Prosulf, Protamine Sulphate Wockhardt Uk
- Greece · Protamine Sulphate Leo Pharma
- Hungary · Protamin-Szulfát Leo Pharma
- Ireland · Protamine Sulphate Leo Pharma
- Iceland · Protaminsulfat Leo Pharma
- Italy · Protamina Solfato
- Lithuania · Protamine Sulphate Leo Pharma
- Luxembourg · Protaminsulfat Leo Pharma, Sulfate De Protamine Leo Pharma
- Malta · Protamine Sulphate, Protamine Sulphate Leo Pharma
- Netherlands · Protamine Sulfaat, Protamine Sulfaat Leo Pharma
- Norway · Protaminsulfat Leo Pharma
- Poland · Protamine, Siarczan Protaminy Wytwórnia Surowic I Szczepionek Biomed
- Portugal · Sulfato De Protamina Leo Pharma
- Romania · Sulfat De Protamina Leo Pharma
- Sweden · Protaminsulfat, Protaminsulfat Leo Pharma
- Slovenia · Protaminijev Sulfat Leo Pharma
- Slovakia · Protamine Sulfate Leo Pharma
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/4c5b8ca8-5e6d-4f51-960f-da8e9c593071 GET /v1/drugs/4c5b8ca8-5e6d-4f51-960f-da8e9c593071?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": "Solution for injection/infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Protamine Sulfaat Leo Pharma 1400 IU/ml",
"name_fr": "Protamine Sulfaat Leo Pharma 1400 IU/ml",
"name_nl": "Protamine Sulfaat Leo Pharma 1400 IU/ml",
"amp_code": "SAM316985-00",
"strengths": [
"1400.0000"
],
"pack_count": 2,
"substances": [
"Protamine Sulfate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Protamine",
"authorisation_numbers": [
"BE316985"
]
}See everything about protamine.
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.