| Name | Azibiot 40 mg/ml prašak za oralnu suspenziju | 
			
				| Marketing Authorisation Number | HR-H-681324227 | 
		
			| Active Substance | azitromicin dihidrat | 
		
			
				| Composition | 1 ml oralne suspenzije sadrži 40 mg azitromicina (u obliku azitromicin dihidrata) | 
			
				| Pharmaceutical Form | prašak za oralnu suspenziju | 
			
				| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija | 
			
				| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska | 
			
				| Marketing Authorisation Date | 29.06.2022 | 
			
				| MA Period of Validity | unlimited | 
			
				| Classification Number | UP/I-530-09/21-02/163 | 
			
				| Registration Number | 381-12-01/154-22-02 | 
			
				| Prescription | Medicinal product subject to medical prescription | 
			
				| Type of prescription | neponovljivi recept 
 | 
			
				| Distribution | Supply through pharmacies (community) | 
			
				| Advertising to general public | not allowed | 
			
				| ATC Code | J01FA10 | 
			
				| Marketing status | nije stavljeno u promet | 
			
				| SmPC | download | 
			
				| PL | download | 
			
				| Public Assessment Report | download 
 |