RoTecPSMA 80 μg

RoTecPSMA 80 μg is a medicine authorised by Swissmedic under authorisation number 69451. The authorisation holder is medeo AG. The medicinal product code is Radiopharmaceuticals and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 08 August 2025 and the authorisation is limited until 07 August 2030. ATC code V09IA10 places the medicine in the group Diagnostic radiopharmaceuticals.

Dispensing category A
Authorisation number 69451
ATC V09IA10
Radiopharmaceuticals

Authorisation data
Authorisation number	69451
Name	RoTecPSMA 80 μg
Full name	RoTecPSMA 80 μg, Kit für ein radioaktives Arzneimittel
Authorisation holder	medeo AG
Medicinal product code	Radiopharmaceuticals
Dispensing category	A · Prescription, not repeatable
ATC code	V09IA10
First authorisation	08 August 2025
Authorisation validity	07 August 2030

Strengths
No.	Name	Dispensing category	Authorisation date
1	RoTecPSMA 80 μg, Kit für ein radioaktives Arzneimittel	A	08 August 2025

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Pack sizes
Pack code	Quantity	Unit	ATC	IT code	Dispensing category
1	2	Durchstechflasche(n)	V09IA10	17.01.9.	A
2	5	Durchstechflasche(n)	V09IA10	17.01.9.	A

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Frequently asked questions

Is RoTecPSMA 80 μg authorised in Switzerland?

Yes. RoTecPSMA 80 μg is authorised by Swissmedic under authorisation number 69451, data as of 01 September 2026. The authorisation is limited until 07 August 2030.

Which dispensing category does RoTecPSMA 80 μg have?

RoTecPSMA 80 μg is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.

Who is the authorisation holder of RoTecPSMA 80 μg?

The authorisation holder is medeo AG. 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.