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Ireland· IE-PA-PA1701/004/001

Gamanil 70mg film-coated tablets

A lofepramine product containing lofepramine hydrochloride, registered in Ireland by Zentiva k.s.. The same ATC class is registered in 3 of our 19 countries.

ATC N06AA07

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedGamanil 70mg film-coated tabletsATCN06AA07REGISTER NO.IE-PA-PA1701/004/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Lofepramine is registered in 3 of 19 countries.

Countries holding a registration under ATC N06AA07 (lofepramine), each read from that country’s own register.

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

Lofepramine · ATC N06AA07

3 / 19 countries

  • Ireland
  • Norwayprice
  • United Kingdom
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
Lofepramine hydrochloride
Manufacturer
Zentiva k.s.
Country
Ireland (IE)
ATC code
N06AA07
ATC class
Lofepramine
Defined daily dose
0.105 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1701/004/001

Regulatory notes

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

Interactions

1 interaction on record for lofepramine.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Lofepramine · interactions on record

1 record

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Lofepramine in 2 other countries

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

All lofepramine products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • United Kingdom (Northern Ireland) · Lofepramine Accord Healthcare, Lofepramine Essential 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 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/ed5569c9-f4f1-4136-9e77-a126f0b0aa79
GET /v1/drugs/ed5569c9-f4f1-4136-9e77-a126f0b0aa79?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": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "N06AA",
    "N06AA07"
  ],
  "strength": null,
  "pa_number": "PA1701/004/001",
  "substances": [
    "Lofepramine hydrochloride"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "14/05/1984",
  "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 lofepramine.

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.