Ambrisentan OrPha 5 mg

Ambrisentan OrPha 5 mg is a medicine authorised by Swissmedic under authorisation number 67500. The authorisation holder is OrPha Swiss GmbH. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 16 December 2022 and the authorisation is limited until 15 December 2027. ATC code C02KX02 places the medicine in the group Antihypertensives.

Dispensing category B
Authorisation number 67500
ATC C02KX02
Synthetic medicines

Authorisation data
Authorisation number	67500
Name	Ambrisentan OrPha 5 mg
Full name	Ambrisentan OrPha 5 mg, Filmtabletten
Authorisation holder	OrPha Swiss GmbH
Medicinal product code	Synthetic medicines
Dispensing category	B · Prescription only
ATC code	C02KX02
First authorisation	16 December 2022
Authorisation validity	15 December 2027

Strengths
No.	Name	Dispensing category	Authorisation date
1	Ambrisentan OrPha 5 mg, Filmtabletten	B	16 December 2022
2	Ambrisentan OrPha 10 mg, Filmtabletten	B	16 December 2022

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Pack sizes
Pack code	Quantity	Unit	ATC	IT code	Dispensing category
1	30	Tablette(n)	C02KX02	02.07.1.	B
2	30	Tablette(n)	C02KX02	02.07.1.	B

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Medicines in the same ATC group

Ambrisentan Devatis 5 mgAuthorisation number 67799 · Devatis AG · ATC C02KX02B Ambrisentan-Mepha 5 mgAuthorisation number 67294 · Mepha Pharma AG · ATC C02KX02B Volibris 5 mgAuthorisation number 58654 · GlaxoSmithKline AG · ATC C02KX02B

Other medicines from this authorisation holder

Amoxicillin OrPha 250 mgAuthorisation number 68815 · ATC J01CA04A Besremi 250 μg / 0Authorisation number 67488 · ATC L03AB15A Cefepime OrPha 1 gAuthorisation number 69642 · ATC J01DE01A EmpressinAuthorisation number 66180 · ATC H01BA01A Esmolol OrPha 100 mg/10 mlAuthorisation number 57413 · ATC C07AB09B Esmolol OrPha LYO 2500 mgAuthorisation number 65741 · ATC C07AB09B Gentamicin OrPha 20 mg/2 mlAuthorisation number 70696 · ATC J01GB03A Meropenem OrPha 500 mgAuthorisation number 70085 · ATC J01DH02A

Frequently asked questions

Is Ambrisentan OrPha 5 mg authorised in Switzerland?

Yes. Ambrisentan OrPha 5 mg is authorised by Swissmedic under authorisation number 67500, data as of 01 September 2026. The authorisation is limited until 15 December 2027.

Which dispensing category does Ambrisentan OrPha 5 mg have?

Ambrisentan OrPha 5 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.

Who is the authorisation holder of Ambrisentan OrPha 5 mg?

The authorisation holder is OrPha Swiss GmbH. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.

Sources

Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.