Sputolysin
Sputolysin
Authorised
- Dembrexine hydrochloride monohydrate
Product identification
Medicine name:
Sputolysin
Active substance:
- Dembrexine hydrochloride monohydrate
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Dembrexine hydrochloride monohydrate5.00/milligram(s)1.00gram(s)
Pharmaceutical form:
-
Oral powder
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal3day
-
Milkno withdrawal periodNicht bei Stuten anwenden, deren Milch für den menschlichen Verzehr vorgesehen ist.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QR05CB90
Legal status of supply:
-
Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Germany
Available in:
-
Germany
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
- Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Klocke Pharma-Service GmbH
- Klocke Pharma-Service GmbH
Responsible authority:
- Federal Office Of Consumer Protection And Food Safety
Authorisation number:
- 3499.00.00
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
This document does not exist in this language (English). You can find it
in another language below.
German (PDF)
Published on: 2/01/2025
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