Replagal

Replagal is a medicine authorised by Swissmedic under authorisation number 55774. The authorisation holder is Takeda Pharma AG. The medicinal product code is Biotechnological medicines 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 28 December 2001 and the authorisation is valid without a time limit. ATC code A16AB03 places the medicine in the group Other alimentary tract and metabolism products.

Dispensing category A
Authorisation number 55774
ATC A16AB03
Biotechnological medicines

Authorisation data
Authorisation number	55774
Name	Replagal
Full name	Replagal, Konzentrat zur Herstellung einer Infusionslösung
Authorisation holder	Takeda Pharma AG
Medicinal product code	Biotechnological medicines
Dispensing category	A · Prescription, not repeatable
ATC code	A16AB03
First authorisation	28 December 2001
Authorisation validity	unlimited

Strengths
No.	Name	Dispensing category	Authorisation date
1	Replagal, Konzentrat zur Herstellung einer Infusionslösung	A	28 December 2001

Scroll the table sideways

Pack sizes
Pack code	Quantity	Unit	ATC	IT code	Dispensing category
1	1	Durchstechflasche(n)	A16AB03	07.14.0.	A

Scroll the table sideways

Other medicines from this authorisation holder

Adcetris 50 mgAuthorisation number 62132 · ATC L01FX05A Advate 250 IE (5 ml)Authorisation number 56352 · ATC B02BD02B Adynovi 250 IE (5 ml)Authorisation number 65953 · ATC B02BD02B Adzynma 500 I.E.Authorisation number 69562 · ATC B01AD13B Agopton 30 mgAuthorisation number 51969 · ATC A02BC03B Alunbrig 30 mgAuthorisation number 66738 · ATC L01ED04A Ceprotin 500 I.E.Authorisation number 56124 · ATC B01AD12B Cinryze 500 IEAuthorisation number 61636 · ATC B06AC01B

Frequently asked questions

Is Replagal authorised in Switzerland?

Yes. Replagal is authorised by Swissmedic under authorisation number 55774, data as of 01 September 2026. The authorisation is valid without a time limit.

Which dispensing category does Replagal have?

Replagal 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 Replagal?

The authorisation holder is Takeda Pharma 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.