Spain· ES:106380006
PREZISTA 100 MG/ML SUSPENSION ORAL
A medicinal product containing darunavir, registered in Spain by Janssen-Cilag International N.V.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- darunavir
- Manufacturer
- Janssen-Cilag International N.V
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Darunavir in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandPrezista 100 mg/ml, orale SuspensionJanssen-Cilag AG
- NetherlandsPrezista 100 mg/ml suspensie voor oraal gebruikJanssen-Cilag International NV
- PolandPrezistaJanssen-Cilag International N.V.
- SwedenPREZISTA 100 mg/ml Oral suspensionJanssen-Cilag International NV
- CzechiaDARUNAVIR KRKAKrka, d.d., Novo mesto, Novo mesto
- United KingdomDarunavir 400mg tabletsAmarox Ltd
- United StatesdarunavirEXELAN PHARMACEUTICALS INC.
- BelgiumDarunavir EG 150 mgEG
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Darunavir Ratiopharm
- Cyprus · Darunavir Accord, Davarino
- Germany · Darunasta, Darunavir Al
- Denmark · Darunavir "sandoz", Darunavir "stada"
- Estonia · Darunavir Auxilia, Darunavir Sandoz
- Finland · Darunavir Accord, Darunavir Medical Valley
- France · Darunavir Accord, Darunavir Arrow
- United Kingdom (Northern Ireland) · Darunavir, Darunavir Accord-Uk
- Greece · Darunavir Accord, Darunavir Vocate
- Croatia · Darunavir Sandoz
- Ireland · Darunavir Clonmel, Darunavir Rowex
- Iceland · Darunavir Krka, Darunavir Medical Valley
- Italy · Darunavir Aurobindo, Darunavir Sandoz
- Liechtenstein · Darunavir Viatris, Prezista
- Netherlands · Darunavir Amarox, Darunavir Glenmark
- Norway · Darunavir Accord, Darunavir Krka
- Poland · Darunavir Aurovitas, Darunavir Sandoz
- Portugal · Darunavir Accord, Darunavir Farmoz
- Romania · Darunavir Sandoz, Darunavir Teva
- Sweden · Darunavir Accord, Darunavir Amarox
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 AEMPS CIMA (Spain). 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/49277eff-46d9-4499-8401-3ee9f06e872d GET /v1/drugs/49277eff-46d9-4499-8401-3ee9f06e872d?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.
{
"cpresc": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1359721360000}",
"nregistro": "106380006",
"substance": "darunavir"
}See everything about darunavir.
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.