Consequent to an evaluation by the European Medicine Agency to harmonise product information across the EU, multiple changes have been made to the product information. The main areas of change relate to removal of certain indications, addition of contraindications, while the duration of treatment for respiratory tract infections has also been amended.
Product Classification:
The concerned products are tablet preparations containing doxycycline for administration to cats and dogs.
Authorisation Holder:
Boehringer Ingelheim Vetmedica GmbH
Ecuphar NV
Target Audience:
Veterinary practitioners, pharmacists.
Problem Or Issue:
The German veterinary regulatory authority identified differences in the authorised conditions of use of the product in various European countries, particularly regarding target species, indications and posology. Accordingly, they initiated a referral procedure to the European Medicines Agency to request that the Committee for Veterinary Medicinal Products (CVMP) conduct a review to harmonise the product information across the EU.
The CVMP agreed to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned medicines in the European Union. Consequently, the CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned medicines were required in order to amend the product information accordingly.
In light of the CVMP’s opinion, the European Commission subsequently issued a decision ((2021)6517 of 30 Aug 2021) to implement the outcome of the referral procedure in the Member States.
As a consequence of the above, the HPRA has recently amended the marketing authorisations of the two relevant products in order to implement the Commission decision.
Concerning Ronaxan 20 mg and 100 mg tablets (VPA10454/075/001-002), the following are the main changes which arise:
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The addition of cats as a target species for Ronaxan 100 mg
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Removal of the following indications:
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Reference to Staphylococcus and Streptococcus spp in dogs and cats
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Treatment of Ehrlichia canis in cats
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Do not use in puppies or kittens before teeth enamel formation
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Addition of the following contraindications:
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The duration of treatment for respiratory tract infections has been amended. The dosing regimen is now 10 mg/kg per day for 5-10 days (previously was up to 5 days).
Concerning Doxycare Flavour 40 mg and 200 mg Tablets for Cats and Dogs (VPA10491/013/001-002), the following are the main changes which arise:
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Removal of the following indication:
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Addition of the following contraindications:
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Do not use in animals with renal or hepatic insufficiency.
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Do not use in animals with known photosensitivity.
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Do not use in puppies and kittens before completion of teeth enamel formation.
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The duration of treatment for respiratory tract infections has been amended. The dosing regimen is now 10 mg/kg per day for 5-10 days (previously was up to 14 days).
Actions To Be Taken:
The HPRA advises veterinary practitioners to follow the updated conditions of the relevant marketing authorisations, as set out above and on the HPRA website pending the availability of new stock with updated labelling and package leaflet reflecting the changes outlined above.
As with all veterinary medicines, any adverse events occurring following use of veterinary medicinal products should be reported to the HPRA via the online reporting form or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.