This medicines update is provided by the Veterinary Medicines Directorate (VMD) and lists new active substance, new marketing authorisations and changes to authorisations most relevant to vets.
New marketing authorisations
Table 1 shows the new marketing authorisations for November 2021.
TABLE 1: New marketing authorisations in November 2021
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New Marketing Authorisations
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Product name and target species
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Active substance
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Authorisation Holder, territory, and distribution category
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Therapeutic group
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Food animals
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Calcibel Forte, 380/60/50 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs
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Magnesium chloride hexahydrate, Boric acid, Calcium gluconate monohydrate
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Bela-Pharm GmbH & Co. KG
GB & NI
POM-V
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Mineral
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See the VMD’s Product Information Database (www.gov.uk/check-animal-medicine-licensed) for more information on each of these products. This includes separate links for the authorisation territories of Great Britain and Northern Ireland.
Please note, there may be a delay between the issuing of a marketing authorisation and the product being placed on the market.
Changes to authorisations most relevant to vets
The changes to authorisations most relevant to vets can be found below. Each product listed, along with the authorisation holder, distribution category and details of which Summary of Product Characteristics sections have been revised/changed.
All entries can be found on the VMD’s Product Information Database here.
Changes to the SPC, labels and leaflets may change how the medicines should be used. There may be a delay between these changes being authorised to implementation on product literature. Unless you have been advised otherwise, the labelling instructions on the pack which is dispensed should be followed.
Equipulmin 25 micrograms/ml syrup for horses
CP Pharma Handelsgesellschaft mbH Authorised in GB & NI POM-V
Section 4.7: Since clenbuterol hydrochloride is excreted in milk, the product should not be used in lactating mares with foals up to the age of two months.
Section 4.8: Enhanced effects including more frequent adverse effects when used concomitantly with ß2 sympathomimetic drugs, anticholinergic substances, and methylxanthines. Increased risk of arrhythmias when administered concomitantly with digitalis glycosides.
Section 4.9: (0.7 micrograms clenbuterol per kg bodyweight). Duration of treatment: 10-14 days in acute or subacute conditions, over a longer period of time in chronic cases. If signs improve significantly, the dosage can be reduced by half after approximately 10 days.
For more information, contact the VMD at postmaster@vmd.gov.uk