Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1823307
Name of medicinal product: Alfadexx
Active substances:
Dexamethasone
Estonian, English, Latin
ATC code: QH02AB02
Dosage form: solution for injection
Route of administration: intravenous use; subcutaneous use; intraarticular use; periarticular use; intramuscular use
Strengh: 2mg 1ml
Amount in package: 100ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Horses, cattle, goats, pigs, dogs and cats: Treatment of inflammation and allergic reactions. Horses: Treatment of arthritis, bursitis or tenosynovitis. Cattle: Treatment of primary ketosis (Acetonemia). Induction of parturition. Goats: Treatment of primary ketosis (Acetonemia).
Safety features: No
Summary of product characteristics (SPC):  (last updated September 29, 2021)
Package information leaflet (PIL): EST  (last updated September 29, 2021)
Labelling:  (last updated September 29, 2021)
Withdrawal time: Veis ja kits Lihale ja söödavatele kudedele: 8 päeva. Piimale: 72 tundi. Siga Lihale ja söödavatele kudedele: 2 päeva pärast intramuskulaarset manustamist. Lihale ja söödavatele kudedele: 6 päeva pärast intravenoosset manustamist. Hobune Lihale ja söödavatele kudedele: 8 päeva. Ei ole lubatud kasutamiseks hobustel, kelle piima tarvitatakse inimtoiduks.
Species: siga, koer, veis, kits, hobune, kass
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Alfasan Nederland B.V. 
Marketing authorization number: 2308 
Marketing authorization issued on: September 29, 2021 
Marketing authorization expires on: September 29, 2026 
Marketing authorization procedure type: Decentralised 
Entry/Changing date: January 14, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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