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Alprolix 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung - Set(s)

Swissmedic Key	66039002 PP	Registration Holder	Swedish Orphan Biovitrum AG
Name	Alprolix 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung	Date of registration	25.10.2016
		Introduction of Sequence	25.10.2016
ATC-Classification	Coagulation Factor Ix (B02BD04)	Revision date
WHO	WHO-DDD	Valid until
Index Therapeuticus (BSV)	06.01.10.	Show package size	Set(s)
Index Therapeuticus (Swissmedic)	06.01.10.	Description
Swissmedic categorie.	B
SL Eintrag	Yes	Indication
Information for professionals	IP	Consumer information
Ex-factory-Price	682.65	Limitation	Yes
Limitation text

Deductible	10 %	Consumer price	741.45
Feedback	FB
GTIN	7680660390029	Medication Code	Biotechnologika
Pharmacode	6849995	Disponibility

Composition

Praeparatio cryodesiccata: eftrenonacogum alfa 500 U.I., histidinum, mannitolum, saccharum, polysorbatum 20, acidum hydrochloridum aut natrii hydroxidum ad pH, pro vitro. Solvens: natrii chloridum, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium 6.4 mg.

Packungsbestandteile

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Eftrenonacogum Alfa	500 UI

Inactive agents
Sodium Chloride

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Eftrenonacogum Alfa	500 UI

BAG: Active Agent	Dose
Eftrenonacogum Alfa	500 UI

Inactive agents
Acidum Hydrochloridum aut Natrii Hydroxidum ad Ph
Histidine
Mannitol
Polysorbatum 20
Saccharum

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Eftrenonacogum Alfa	500 UI

Inactive agents
Sodium Chloride

Source

Data was imported : 08.11.2023 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 :

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