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Marketing-authorisation holder

Pharmaxis Europe Limited

10 medicines6 countries

10 medicines in 6 countries, as authorisation holder.

Its medicines

Group structure

Part of

PharmaxisPharmaceutical group

Other companies in the group

Headquarters not stated1

Pharmaxis Ltd

Groups are put together by Prognia from the names regulators publish and from company links; they are not an official corporate structure.

Medicines

Every medicine in the registers under its name, current ones first.

10 medicines

Medicine	Substance	Country	Status	Authorised
ARIDOL10mg \| 20mg \| 40mg · Powder	Mannitol	United States	Marketed	2010
ARIDOL40 mg / cap + 20 mg / cap + 5 mg / cap + 10 mg / cap · Kit, Powder	Mannitol	Canada	Marketed	2020
ARIDOL KIT5mg,10mg,20mg,40mg · Powder	Mannitol n/a,5mg,10mg,20mg,40mg	United States	Marketed	2010
BRONCHITOLCapsula rigida	Mannitol	Italy	Authorised
BRONCHITOL40mg · Powder	Mannitol	United States	Marketed	2020
Bronchitol	Mannitol	EU (EMA)	Authorised	2012
Bronchitol 40 mg inhalatiepoeder, harde capsulesInhalatiepoeder in harde capsule	Mannitol	Netherlands	Authorised	2012
BRONCHITOL 40 MG POLVO PARA INHALACION, CAPSULAS DURAS40 mg · Polvo para inhalación (cápsula dura)	Mannitol	Spain	Marketed	2016
Osmohale, inhalatiepoeder in harde capsulesInhalatiepoeder in harde capsule	Mannitol	Netherlands	Authorised	2007
OSMOHALE POLVO PARA INHALACION (CAPSULAS DURAS)0 mg + 5 mg + 10 mg + 20 mg + 40 mg · Polvo para inhalación (cápsula dura)	Mannitol	Spain	Marketed	2008

Sources and licences

Country	Medicines	Current	Companies
United States	3	3	Companies All medicines
Spain	2	2	Companies All medicines
Netherlands	2	2	Companies All medicines
Canada	1	1	Companies All medicines
European Union (EMA)	1	1	Companies All medicines
Italy	1	1	Companies All medicines

Compiled by Prognia from the public medicine and company registers below. Logos are not used.

European Medicines Agency

Source: European Medicines Agency (EPAR data).

Licence: EMA reuse policy (source acknowledgement required)

Agencia Española de Medicamentos y Productos Sanitarios (CIMA)

Fuente de la información: AEMPS (CIMA).

Licence: AEMPS open data reuse with attribution

U.S. Food and Drug Administration (Drugs@FDA, openFDA)

Source: U.S. FDA, Drugs@FDA / openFDA. FDA does not endorse this site.

Licence: Public domain (U.S. Government work)

Health Canada, Canada

Health Canada, Drug Product Database, company API, entire response observed 2026-10-10T15:12:05.508784+00:00; native facts projected by Prognia.

Licence: Open Government Licence Canada

Health Canada, Canada

Health Canada, Drug Product Database, drugproduct API, entire response observed 2026-10-10T15:12:07.336870+00:00; native facts projected by Prognia.

Licence: Open Government Licence Canada

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA presentaciones, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required

All 11 sources

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA), GOV.UK; Category 1 list; publication updated 25 August 2026; acquired 2026-10-15T08:18:47.757811+00:00; original workbook cells and factual authorization/holder projections adapted under Open Government Licence v3.0.

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA), GOV.UK; Category 2 list; publication updated 25 August 2026; acquired 2026-10-15T08:18:48.423930+00:00; original workbook cells and factual authorization/holder projections adapted under Open Government Licence v3.0.

Agenzia Italiana del Farmaco (AIFA), Italy

Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.

Licence: CC BY 4.0; AIFA published open-data catalog

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim

Report an error or request removalCorrections from the company itself are welcome.

Pharmaxis Europe Limited

Group structure

Part of

Other companies in the group

Headquarters not stated1

Medicines

Know your medicines, with the sources.

Countries

Therapeutic areas

Top substances

Names in the registers

Sources and licences

At a glance