Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-7 October 2020
CVMP recommends authorisation of four new vaccines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation application for CircoMax Myco from Zoetis Belgium SA, a new vaccine for the active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with PCV2 infection. Protection was demonstrated against porcine circovirus types 2a, 2b and 2d. Active immunisation of pigs against Mycoplasma hyopneumoniae to reduce the lung lesions associated with Mycoplasma hyopneumoniae infection. In addition, vaccination has been shown to reduce body weight gain losses under field conditions.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Enteroporc Coli AC from IDT Biologika GmbH, a new vaccine for the active immunisation of pregnant gilts and sows to provide passive protection to piglets against porcine neonatal diarrhoea caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6 and enteric disease caused by toxins of Clostridium perfringens types A and C.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Nobivac DP Plus from Intervet International B.V., a new vaccine for the active immunisation of puppies from 4 weeks of age to prevent clinical signs and mortality of canine distemper virus infection and canine parvovirus infection and to prevent viral excretion following canine distemper virus infection and following canine parvovirus infection.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Vectormune FP ILT from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Rexxolide (tulathromycin) from Dechra Regulatory B.V., a generic product for the treatment and metaphylaxis of bovine respiratory disease, treatment of infectious bovine keratoconjunctivitis, treatment and metaphylaxis of swine respiratory disease and treatment of the early stages of infectious pododermatitis in sheep.
The Committee adopted by consensus a positive opinion for a type II variation application for Innovax-ND-IBD to extend the duration of immunity for the protection against Newcastle disease and infectious bursal disease from 8 weeks to 60 weeks.
The Committee adopted by consensus a positive opinion for a grouped type II variation application for Arti-Cell Forte concerning quality-related changes.
More information about the above-mentioned medicines, including their full indications, will be published on the Agency’s website.
Maximum residue limits
The Committee agreed to include dipropylene glycol, 1,2-benzisothiazol-3(2H)-one and polydimethylsiloxane, hydroxy-terminated as new entries in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients. A revised list (EMA/CVMP/519714/2009-Rev. 46) was adopted. This decision followed the Committee’s review of requests that had been submitted in accordance with the relevant CVMP guidance.
The document will be published on the Agency’s website.
Scientific advice
The Committee adopted two scientific advice reports further to requests for:
- Follow-up advice on safety issues for a new veterinary medicinal product for a musculoskeletal disorder indication in dogs;
- Follow-up advice on efficacy issues for a new veterinary medicinal product for a gastrointestinal disorder indication in dogs.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of six requests for classification under the MUMS/limited market policy, the CVMP classified:
- A product for dogs (ATCvet classification: nervous system) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.
- A product for dogs (ATCvet classification: sensory organs) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.
- A product for sheep (ATCvet classification: antiparasitic products, insecticides and repellents) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product was not eligible for financial incentives due to the existence of a currently authorised alternative product in the EU.
- A product for goats (ATCvet classification: antiparasitic products, insecticides and repellents) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
- A product for cats (ATCvet classification: antiparasitic products, insecticides and repellents) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.
- The CVMP did not classify a product for dogs (ATCvet classification: genitourinary system and sex hormones) as indicated for MUMS/limited market and the product was not therefore eligible for financial incentives.
Following the Committee’s review of two requests for reclassification under the MUMS/limited market policy, the CVMP reclassified:
- A product for horses (ATCvet classification: immunologicals) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives, as according to the MUMS policy products for horses are generally not eligible for fee incentives, and due to the existence of a currently authorised alternative product in the EU.
- A product for wild boars (ATCvet classification: immunologicals) as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
Pharmacovigilance
The Committee reviewed the PSURs for Baycox Iron, Bluevac BTV8, Nobivac Myxo RHD Plus, Respiporc FLUPan H1N1, Simparica and MiPet Easecto, and Zycortal, and concluded that no further action or changes to their product information were required.
Working parties
The Committee re-elected C. Muñoz Madero as chair of the CVMP Efficacy Working Party for a 3-year mandate and appointed a new panel of members under the revised mandate, objectives and rules of procedure for the CVMP Efficacy Working Party.
The Committee re-elected E. Dewaele as chair of the CVMP Pharmacovigilance Working Party for a 3-year mandate.
The Committee elected D. Bouchard as vice-chair of the CVMP Antimicrobials Working Party for a 3-year mandate.
The Committee appointed a new panel of members under the revised mandate, objectives and rules of procedure for the CVMP Safety Working Party.
