Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Veterinary medicine
|
Name of medicinal product:
|
Dalmazin SYNCH
|
Active substances:
|
|
ATC code:
|
QG02AD90
|
Dosage form:
|
solution for injection
|
Strength:
|
0,075mg 1ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated July 29, 2021)
|
Package information leaflet (PIL):
|
EST (last updated July 29, 2021)
|
Labelling:
|
(last updated July 29, 2021)
|
Indication:
|
The product is indicated for:
Cows:
Synchronisation or induction of oestrus;
Induction of parturition after day 270 of gestation;
Treatment of ovarian dysfunction (persistent corpus luteum, luteal cyst);
Treatment of clinical endometritis with the presence of a functional corpus luteum and pyometra;
Treatment of delayed uterine involution;
Induction of abortion up to day 150 of gestation;
Expulsion of mummified foetuses.
Sows:
Induction of parturition after day 114 of gestation.
Mares:
Induction of luteolysis with a functional corpus luteum.
|
Safety features:
|
No
|
Marketing authorization holder:
|
Fatro S.p.A.
|
Marketing authorization number:
|
2200
|
Marketing authorization issued on:
|
September 24, 2019
|
Marketing authorization expires on:
|
September 24, 2024
|
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
|
1773929
|
Dalmazin SYNCH
|
solution for injection
|
0,075mg 1ml 2ml 15TK
|
Prescription
|
|
|
|
|
|
1773930
|
Dalmazin SYNCH
|
solution for injection
|
0,075mg 1ml 2ml 60TK
|
Prescription
|
|
|
|
|
|
1773941
|
Dalmazin SYNCH
|
solution for injection
|
0,075mg 1ml 10ml 1TK
|
Prescription
|
|
|
|
|
|
1773952
|
Dalmazin SYNCH
|
solution for injection
|
0,075mg 1ml 20ml 1TK
|
Prescription
|
|
|
08.03.2024
|
|
|
1773963
|
Dalmazin SYNCH
|
solution for injection
|
0,075mg 1ml 100ml 1TK
|
Prescription
|
|
|
08.03.2024
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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