SAI - Detailed view

GIVLAARI Inj Lös 189 mg/ml Durchstf 1 ml

Drug

Name

Givlaari, concentrate for solution for injection

Field of application

Givlaari ist indiziert für die Behandlung einer akuten hepatischen Porphyrie (AHP) bei Erwachsenen und Jugendlichen ab 12 Jahren

ATC

A16AX - VARIOUS ALIMENTARY TRACT AND METABOLISM PRODUCTS

07.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

LSINJ – Solution for injection

Remedy code

TGT – transplant product: gene therapy product

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

67895

Initial registration date

3/29/2021

Expiry date

3/28/2026

Dosage strength

Name

Givlaari 189 mg/ml, Injektionslösung

Field of application

Givlaari ist indiziert für die Behandlung einer akuten hepatischen Porphyrie (AHP) bei Erwachsenen und Jugendlichen ab 12 Jahren

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680678950017

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Application type

SUBC – Subcutaneous use

Package code

001

Authorisation status

Z – approved

Declaration

Component Solution

Active substance

189 mg givosiranum
givosiranum natricum

Excipient

natrii hydroxidum
acidum phosphoricum
aqua ad iniectabile
11 mg natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

43049.75

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001408906

Address

Alnylam Switzerland GmbH
Grafenauweg 4
6300 Zug (ZG)

Date of revision of the text

10/4/2024

Information for prof.

Leaflet

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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.