Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Veterinary medicine
|
Name of medicinal product:
|
BelaZin
|
Active substances:
|
|
ATC code:
|
QN05CM92
|
Dosage form:
|
solution for injection
|
Strength:
|
20mg 1ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated March 31, 2020)
|
Package information leaflet (PIL):
|
EST (last updated March 31, 2020)
|
Labelling:
|
(last updated March 31, 2020)
|
Indication:
|
Horses:
For sedation and muscle relaxation. In combination with other substances for analgesia and anaesthesia.
Cattle:
For sedation, analgesia and muscle relaxation. In combination with other substances for anaesthesia.
Dogs, cats:
For sedation. In combination with other substances for analgesia, anaesthesia and muscle relaxation.
|
Safety features:
|
No
|
Marketing authorization holder:
|
Bela-Pharm GmbH & Co. KG
|
Marketing authorization number:
|
2230
|
Marketing authorization issued on:
|
March 31, 2020
|
Marketing authorization expires on:
|
March 31, 2025
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1788060
|
BelaZin
|
solution for injection
|
20mg 1ml 25ml 1TK
|
Prescription
|
|
|
|
|
|
1788071
|
BelaZin
|
solution for injection
|
20mg 1ml 25ml 10TK
|
Prescription
|
|
|
|
|
|
1788082
|
BelaZin
|
solution for injection
|
20mg 1ml 50ml 1TK
|
Prescription
|
|
|
|
|
|
1788093
|
BelaZin
|
solution for injection
|
20mg 1ml 50ml 12TK
|
Prescription
|
|
|
|
|
|
1813531
|
BelaZin
|
solution for injection
|
20mg 1ml 25ml 12TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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