Ireland· IE-PA-PA22998/007/001
Kelzy 2 mg/0.02 mg prolonged release tablets
A dienogest und ethinylestradiol product containing dienogest + ethinylestradiol, registered in Ireland by Exeltis Healthcare S.L.. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Dienogest und ethinylestradiol is registered in 9 of 19 countries.
Countries holding a registration under ATC G03AA16 (dienogest und ethinylestradiol), 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
Dienogest und ethinylestradiol · ATC G03AA16
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Dienogest + Ethinylestradiol
- Manufacturer
- Exeltis Healthcare S.L.
- Country
- Ireland (IE)
- ATC code
- G03AA16
- ATC class
- Dienogest und Ethinylestradiol
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA22998/007/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
1 interaction on record for dienogest und ethinylestradiol.
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
Dienogest und ethinylestradiol · interactions on record
1 record
1 more interaction with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Dienogest und ethinylestradiol in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAIDEEVIVAX Pharmaceuticals, s.r.o., Povážská Bystrica
- PolandAideeDelfarma Sp. z o.o.
- GermanyAmobenaBiomo Pharma Gmbh
- SpainADIERIS 2 mg/0,03 mg COMPRIMIDO RECUBIERTO CON PELICULA EFGLaboratorios Cinfa S.A.
- SwitzerlandCemisiana 2 mg / 0.03 mg, FilmtablettenSandoz Pharmaceuticals AG
- FinlandCelimonaBayer Schering Pharma Oy
- FranceJEZTIQ 2 mg/0,02 mg, comprimé à libération prolongéeEXELTIS SANTE
- NetherlandsKelzyn 2mg/0,02 mg, tablet met verlengde afgifteExeltis Healthcare S.L
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Dienorette, Dienovel
- Belgium · Dienobel, Louise
- Bulgaria · Жанин
- Czechia · Aidee, Ayreen
- Germany · Amobena, Aristelle
- Denmark · Yana
- Estonia · Ammily, Jeanine
- Spain · Adieris, Ailyn Diario
- Finland · Yanulez
- France · Misolfa
- United Kingdom (Northern Ireland) · Dienogest/Ethinylestradiol, Serisima
- Croatia · Donella
- Hungary · Dienille, Mistral
- Italy · Cemisiana, Dienestra
- Lithuania · Ammily, Jeanine
- Luxembourg · Dienobel, Louise
- Latvia · Ammily, Jeanine
- Netherlands · Ethinylestradiol/Dienogest Mithra, Misolfa
- Norway · Yana
- Poland · Aidee, Astha
- Portugal · Denille, Dienogest + Etinilestradiol Leon Farma
- Slovakia · Aidee, Dienorette
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/8364a9c3-f163-4063-9d78-ab017bf288df GET /v1/drugs/8364a9c3-f163-4063-9d78-ab017bf288df?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": "Prolonged-release tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"G03AA16"
],
"strength": null,
"pa_number": "PA22998/007/001",
"substances": [
"Dienogest",
"Ethinylestradiol"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "05/07/2024",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about dienogest und ethinylestradiol.
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.