Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
Name of medicinal product: Oxytobel
Active substances:
Oxytocin
Estonian, English, Latin
ATC code: QH01BB02
Dosage form: solution for injection
Strength: 10RÜ 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated March 5, 2019)
Package information leaflet (PIL): EST  (last updated March 5, 2019)
Labelling:  (last updated March 5, 2019)
Indication: In the mare, cow, sow, ewe, nanny, bitch and queen the product is indicated for: •Obstetric use (stimulation of uterine contraction to facilitate parturition in the presence of a fully dilated cervix, promotion of involution of the post partum uterus, aid in the control of post partum haemorrhage). •Promotion of milk let-down in cases of agalactia.
Safety features: No
Marketing authorization holder: Bela-Pharm GmbH & Co. KG 
Marketing authorization number: 1885 
Marketing authorization issued on: December 22, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Assessment report:  (last updated February 16, 2015) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1655085  Oxytobel  solution for injection  10RÜ 1ml 10ml 1TK  Prescription           
1655096  Oxytobel  solution for injection  10RÜ 1ml 10ml 5TK  Prescription           
1655108  Oxytobel  solution for injection  10RÜ 1ml 10ml 12TK  Prescription           
1655119  Oxytobel  solution for injection  10RÜ 1ml 25ml 1TK  Prescription           
1655120  Oxytobel  solution for injection  10RÜ 1ml 25ml 10TK  Prescription           
1655131  Oxytobel  solution for injection  10RÜ 1ml 50ml 1TK  Prescription      03.02.2023     
1655142  Oxytobel  solution for injection  10RÜ 1ml 50ml 12TK  Prescription           
1655153  Oxytobel  solution for injection  10RÜ 1ml 50ml 6TK  Prescription           
1655164  Oxytobel  solution for injection  10RÜ 1ml 100ml 1TK  Prescription           
1655175  Oxytobel  solution for injection  10RÜ 1ml 100ml 12TK  Prescription           
1655186  Oxytobel  solution for injection  10RÜ 1ml 100ml 6TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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