Spain· ES:08477001
CEPLENE 0,5 mg/0,5 ml SOLUCION INYECTABLE
A medicinal product containing histamina dihidrocloruro, registered in Spain by Laboratoires Delbert.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- histamina dihidrocloruro
- Manufacturer
- Laboratoires Delbert
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Histamina dihidrocloruro in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumCeplene 0.5 mg/0.5 mlNoventia Pharma
- CzechiaCEPLENELaboratoires Delbert, Paříž
- IcelandCepleneLaboratoires Delbert
- NorwayCepleneLaboratoires Delbert
- PolandCepleneLaboratoires Delbert
- SwedenCeplene 0,5 mg/0,5 ml Injektionsvätska, lösningLaboratoires Delbert
- United States2nd CHANCE MOBILITY Pain ReliefALPHA NUTRITION, LLC
- United KingdomCeplene 0.5mg/0.5ml solution for injection vialsMeda Pharmaceuticals Ltd
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Alk Prick Positiv Kontrolle, Alyostal Prick, Allergenextrakte
- Belgium · Histamine Di Hcl Hal Allergy, Soluprick Contrôle Positif
- Bulgaria · Алиостал Прик, Алергенен Екстракт От Дървесни Полени, Алиостал Прик, Алергенен Екстракт От Животински Произход
- Czechia · Alyostal Prick, Soluprick Sq
- Germany · Alk-Prick Positiv-Kontrolle, Histamin-Kontrollösung Bencard Allergie
- Denmark · Alk Soluprick Positiv Kontrol
- Finland · Soluprick Positiivinen Kontrolli, Soluprick® Positiv Kontroll
- France · Alyostal Prick Controle Positif, Soluprick Controle Positif
- United Kingdom (Northern Ireland) · Soluprick Positive Control
- Ireland · Soluprick Positive Control
- Iceland · Ceplene, Soluprick Positiv Kontrol
- Liechtenstein · Ceplene
- Lithuania · Alyostal Prick Teigiama Kontrolė
- Luxembourg · Soluprick Contrôle Positif, Soluprick Positiv Kontrolle
- Netherlands · Prick Test Positieve Controle, Soluprick Controlevloeistoffen
- Norway · Ceplene, Soluprick Positiv Kontroll
- Poland · Alyostal, Kontrola Dodatnia Prick Test Hal Allergy
- Portugal · Histamina Hal Allergy
- Sweden · Soluprick Positiv Kontroll
- Slovenia · Alyostal Vbodni
- Slovakia · Alyostal Prick, Soluprick
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/f68a835b-8d4b-4ab1-bce3-fe9effe17ec2 GET /v1/drugs/f68a835b-8d4b-4ab1-bce3-fe9effe17ec2?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": "Uso Hospitalario",
"estado": "{\"aut\":1343080800000}",
"nregistro": "08477001",
"substance": "histamina dihidrocloruro"
}See everything about histamina dihidrocloruro.
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.