Tulatrixx : Withdrawal of the marketing authorisation application



The applicant Emdoka BVBA submitted on 4 October 2019 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Tulatrixx through the centralised procedure under Article 3(3) of Regulation (EC) No 726/2004 (generic).

The eligibility to the centralised procedure was agreed by the CVMP on 22 May 2019 as the product would constitute a generic of a product authorised through the centralised procedure - Draxxin (reference product).

The applicant applied for the following indications:

Cattle (100 mg/ml)

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs (25 mg/ml and 100 mg/ml)

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Tulatrixx should only be used if pigs are expected to develop the disease within 2-3 days.

Sheep (100 mg/ml)

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

The active substance of Tulatrixx is tulathromycin, a semi-synthetic macrolide antimicrobial agent, which is a bacteriostatic acting antibiotic and inhibits essential protein biosynthesis by virtue of its selective binding to bacterial ribosomal RNA. It stimulates the dissociation of peptidyl-tRNA from the ribosome during the translocation process. The target species are cattle, pigs and sheep for Tulatrixx 100 mg/ml and pigs only for Tulatrixx 25 mg/ml.

The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

The dossier has been submitted in line with the requirements for submissions under Article 13(1) of Directive 2001/82/EC – a generic application.

On 1 April 2020, Emdoka BVBA communicated the withdrawal of the marketing authorisation application at day 120 of the procedure to the Agency.

Key facts

Product number
International non-proprietary name (INN) or common name
  • tulathromycin
Active substance
  • tulathromycin
Date of withdrawal
Company making the application
Emdoka BVBA
Withdrawal type
Initial authorisation

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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