ODDB.org: Open Drug Database

Refixia 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung -

Swissmedic Key	66216001	Registration Holder	Novo Nordisk Pharma AG
Name	Refixia 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung	Date of registration	05.09.2017
		Introduction of Sequence	05.09.2017
ATC-Classification	Coagulation Factor Ix (B02BD04)	Revision date
WHO	WHO-DDD	Valid until
Index Therapeuticus (BSV)	06.01.10.	Show package size
Index Therapeuticus (Swissmedic)	06.01.10.	Description
Swissmedic categorie.	B
SL Eintrag	Yes	Indication
Information for professionals	IP	Consumer information	CI
Ex-factory-Price	889.38	Limitation	Yes
Limitation text

Deductible	10 %	Consumer price	953.55
Feedback	FB
GTIN	7680662160019	Medication Code	Biotechnologika
Pharmacode	7229875	Disponibility

Composition

Praeparatio cryodesiccata: nonacogum beta pegolum 500 U.I., natrii chloridum, histidinum, saccharum 10 mg, mannitolum, polysorbatum 80, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, pro vitro corresp. natrium 0.972 mg/ml. Solvens: histidinum, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium.

Packungsbestandteile

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Nonacogum beta Pegolum	500 UI

Inactive agents
Histidine

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Nonacogum beta Pegolum	500 UI

BAG: Active Agent	Dose
Nonacogum beta Pegolum	500 UI

Inactive agents	Dose
Acidum Hydrochloridum ad Ph
Histidine
Mannitol
Sodium Chloride
Natrii Hydroxidum ad Ph
Polysorbatum 80
Saccharum	10 mg

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Nonacogum beta Pegolum	500 UI

Inactive agents
Acidum Hydrochloridum ad Ph
Histidine
Natrii Hydroxidum ad Ph

Source

Data was imported : 04.07.2024 Swissmedic Registration : Sequence : Product name : Registration owner: : Product group : Index Therapeuticus (BSV) : Medication Code : Date of registration : Valid until : Package number : Show package size : Commercial Form/Unit : Swissmedic categorie. : Active Agents : Composition :

2025	©ywesee GmbH