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Esperoct 1000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung -

Swissmedic Key	67156002	Registration Holder	Novo Nordisk Pharma AG
Name	Esperoct 1000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung	Date of registration	30.07.2019
		Introduction of Sequence	30.07.2019
ATC-Classification	Coagulation Factor Viii (B02BD02)	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
Ex-factory-Price	746.37	Limitation	Yes
Limitation text

Deductible	10 %	Consumer price	806.80
Feedback	FB
GTIN	7680671560022	Medication Code	Biotechnologika
Pharmacode	7750437	Disponibility

Composition

Praeparatio cryodesiccata: turoctocogum alfa pegolum 1000 U.I., histidinum, saccharum, polysorbatum 80, natrii chloridum corresp. natrium 14.16 mg, methioninum, calcii chloridum dihydricum, acidum hydrochloridum ad pH, natrii hydroxidum ad pH, pro vitro. Solvens: natrii chloridum corresp. natrium 14.16 mg, aqua ad iniectabile q.s. ad solutionem pro 4 ml.

Packungsbestandteile

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Turoctocogum alfa Pegolum	1000 UI

BAG: Active Agent	Dose
Turoctocogum alfa Pegolum	1000 UI

Inactive agents
Acidum Hydrochloridum
Calcium Chloride
Histidine
Methionine
Sodium Chloride
Polysorbatum 80
Saccharum

Label

Praeparatio cryodesiccata:

Galenic Form

Lyophilisate and solvent

Excipiens

Active Agent	Dose
Turoctocogum alfa Pegolum	1000 UI

BAG: Active Agent	Dose
Turoctocogum alfa Pegolum	1000 UI

Inactive agents
Acidum Hydrochloridum ad Ph
Calcium Chloride
Histidine
Methionine
Sodium Chloride
Natrii Hydroxidum ad Ph
Polysorbatum 80
Saccharum

Label

Solvens

Galenic Form

Lyophilisate and solvent

Excipiens

BAG: Active Agent	Dose
Turoctocogum alfa Pegolum	1000 UI

Inactive agents
Sodium Chloride

Source

Data was imported : 04.12.2024 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 :

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