Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1565096
Name of medicinal product: Ovarelin
Active substances:
Gonadorelin
Estonian, English, Latin
ATC code: QH01CA01
Dosage form: solution for injection
Route of administration: intramuscular use
Strengh: 50mcg 1ml
Amount in package: 4ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F2alfa (PGF2alfa) or analogue with or without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols. Treatment of delayed ovulation (repeat breeding). A repeat breeder cow or heifer is generally defined as an animal that has been inseminated at least 2 or often 3 times without becoming pregnant, despite having regular normal oestrus cycles (every 18 -24 days), normal oestrus behaviour and no clinical abnormalities of the reproductive tract.
Safety features: No
Summary of product characteristics (SPC):  (last updated April 10, 2019)
Package information leaflet (PIL): EST  (last updated April 10, 2019)
Labelling:  (last updated April 10, 2019)
Withdrawal time: Lihale ja söödavatele kudedele: 0 päeva. Piimale: 0 tundi
Species: veis
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Ceva Sante Animale 
Marketing authorization number: 1743 
Marketing authorization issued on: December 21, 2012 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Entry/Changing date: March 20, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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