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List of referrals for veterinary medicinal products

Tiamutin premix and associated names

Product name: Tiamutin premix and associated names
Also marketed in the EU under the name(s): Denagard, Dynamutilin
INN: Tiamulin hydrogen fumarate
Indication: Pigs
- Treatment of Swine Dysentery caused by B. hyodysenteriae, treatment of Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli
- Prevention of Swine Dysentery caused by B. hyodysenteriae
- Treatment of Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis
Chickens (broiler, replacement pullet, laying and breeding hens)
- Treatment and prevention of chronic respiratory disease (CRD) caused by M. gallisepticum and air sacculitis and infectious synovitis caused by M. synoviae.
Turkeys (young poults, breeding turkeys)
- Treatment and prevention of infectious sinusitis and air sacculitis caused by M. gallisepticum, M. synoviae and M. meleagridis.
Rabbits
- Treatment of Epizootic Rabbit Enterocolitis (ERE) and prevention of ERE in farms with clinical signs of ERE in the previous fattening cycle as part of a programme including measures aiming to eradicate or control the infection in the farm.
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
28/07/2010 Referral EMEA/V/A-34/42 (2010)5372 of 27/07/2010
14/03/2011 Corrigendum (2011)1737 of 10/03/2011