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Ireland· IE-PA-EU/1/08/477/1

Ceplene 0.5 mg/0.5 ml solution for injection

A histamine dihydrochloride product containing histamine dihydrochloride, registered in Ireland by Laboratoires DELBERT. The same ATC class is registered in 10 of our 19 countries.

ATC L03AX14

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedCeplene 0.5 mg/0.5 ml solution for in…ATCL03AX14REGISTER NO.IE-PA-EU/1/08/477/1PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Histamine dihydrochloride is registered in 10 of 19 countries.

Countries holding a registration under ATC L03AX14 (histamine dihydrochloride), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Histamine dihydrochloride · ATC L03AX14

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Histamine dihydrochloride
Manufacturer
Laboratoires DELBERT
Country
Ireland (IE)
ATC code
L03AX14
ATC class
Histamine dihydrochloride
Defined daily dose
0.5 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/08/477/1

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

42 interactions on record for histamine dihydrochloride.

Graded by severity as the source publishes them — 42 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Histamine dihydrochloride · interactions on record

42 records

  • 42 moderate

Most severe, free to view

  • DiphenhydraminA04AB05moderate
  • CyproheptadinA15AA01moderate
  • DiphenhydraminN01BX06moderate
  • HydroxyzineN05BB01moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Histamine dihydrochloride in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All histamine dihydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 20 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
  • 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 HPRA (Ireland). 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/2f3fd445-3202-4e1f-bc42-95700a0707a2
GET /v1/drugs/2f3fd445-3202-4e1f-bc42-95700a0707a2?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",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "L03AX",
    "L03AX14"
  ],
  "strength": null,
  "pa_number": "EU/1/08/477/1",
  "substances": [
    "Histamine dihydrochloride"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "07/10/2008",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about histamine dihydrochloride.

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.