Member State Marketing authorisation holder Product trade name Strength Pharma-ceutical form Animal species Frequency Recommended dose Withdrawal period (meat and milk)

AUSTRIA Pfizer Corp. Austria Seidengasse 33-35 A-1071 Wien Dectomax 1 % Injektions-lösung für Rinder und Schafe 10 mg/ml Solution for injection Cattle and sheep No treatment of animals producing milk for human consumption Single dose 200 μg/kg bw Meat: Cattle: 42 days Sheep: 40 days

BELGIUM Pfizer Animal Health S.A. Rue Laid Burniat 1 B-1348 Louvain-la-Neuve Dectomax 10 mg/ml Solution for injection Cattle and sheep Single dose 200 μg/kg bw Meat: Cattle: 42 days Sheep: 35 days Milk: Cattle: 60 days Sheep: 70 days

DENMARK Pfizer Aps Lautrupvang 8 DK 2750 Ballerup Dectomax Vet DK MT NO 15721 10 mg/ml Solution for injection Cattle Not to be used in cattle producing milk for human consumption. Single dose 200 μg/kg bw Meat: 45 days Milk: Not to be used later than 60 days prior to expected calving.

FINLAND Pfizer Oy, Animal Health Tietokuja 4 FI-00330 Helsinki Dectomax Vet 10 mg/ml Solution for injection Cattle, Reindeer, Pigs Not permitted for use in animals producing milk for human consumption during lactation Single dose Cattle and reindeer: 200 μg/kg bw Swine: 300 μg/kg bw Meat: Cattle and reindeer: 42 days Swine: 49 days Milk: Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period

FRANCE Pfizer 23/25 Ave du docteur Lannelongue F-75014 Paris Dectomax 10 mg/ml Solution for injection Cattle and sheep Not for use in dairy cows during lactating or drying off and not for use in dairy ewes Single dose Cattle: 200 μg/kg bw (sc only) Sheep: 200 μg/kg bw (sc or im) Meat: Cattle: 42 days Sheep: 35 days (im), 56 days (sc)

GERMANY Pfizer GmbH Pfizerstraße 1 D-76139 Karlsruhe Dectomax 10 mg/ml Solution for injection Cattle and sheep Not permitted for use in lactating animals producing milk for human consumption Single dose 200 μg/kg bw Meat: Cattle, sheep: 60 days

GREECE Pfizer Hellas Alketou 5 GR-11633 Pagrati — Athina Dectomax 10 mg/ml Solution for injection Sheep Cattle Not for use in dairy cows Pigs Single dose Sheep: 200 μg/kg bw (sc, im) Cattle: 200 μg/kg bw (sc) Pigs: 300 μg/kg bw (im) Meat: Sheep: 35 days Cattle: 42 days Pigs: 49 days Milk: Sheep: Do not use in dairy sheep, including pregnant ewes within 50 days of lambing Cattle: Do not use in non lactating dairy cows including pregnant dairy heifers within 60 days of calving

IRELAND Pfizer Ltd. Walton Oaks, Dorking Road Tadworth, Surrey KT20 7NT United Kingdom Dectomax 1 % Injectable solution 10 mg/ml Solution for injection Cattle and sheep Single dose Cattle: 200 μg/kg bw Sheep: 300 μg/kg bw Meat Cattle: 63 days Sheep: 63 days

ITALY Pfizer Italia SRL Via Valbondione 113 I-00188 Roma Dectomax 1 % (doramectin) 10 mg/ml Solution for injection Cattle, sheep and pigs Use not permitted in animals producing milk for human use Single dose Cattle and sheep: 200 μg/kg bw Pigs: 300 μg/kg bw Meat: Cattle: 42 days Sheep: 35 days Pigs: 37 days

LUXEMBOURG Pfizer Animal Health Rue Laid Burniat 1 B-1348 Louvain-la-Neuve Dectomax 10 mg/ml Injection Cattle and sheep Not for use in cattle producing milk for human consumption. Not for use in sheep producing milk for human consumption Single dose Cattle: 200 μg/kg bw (sc) Sheep: 300 μg/kg bw (sc or im) Meat: Cattle: 42 days Sheep: 35 days Milk: Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving. Sheep: Not for use in the last 70 days before lambing

THE NETHERLANDS Pfizer Animal Health BV PO Box 37 2900 AA Capelle aan den IJssel Nederland Dectomax (REG NL 9844) Prontax (REG NL 9884) 10 mg/ml Solution for injection Non-lactating cattle and sheep, pigs Single dose. Sheep; repeated if signs of P.ovis infection do not disappear in 14 days Cattle and sheep: 200 μg/kg bw Pigs: 300 μg/kg bw Meat: Cattle: 75 days Sheep: 70 days Pigs: 77 days Milk: Cattle and sheep: product not allowed for milking sheep.

PORTUGAL Laboratórios Pfizer, Lda Lagoas Park Edifício 10 P-2740-244 Porte Salvo Dectomax solution injectable 10 mg/ml Solution for injection Cattle, sheep and pigs Single dose Cattle and sheep: 200 μg/kg bw Pigs: 300 μg/kg bw Meat: Cattle: 42 days Sheep: 35 days Pigs: 56 days Milk: Cattle: Forbidden in lactating cows, not to be administered 60 days before calving Sheep: Forbidden in lactating sheep, not to be administered 70 days before lambing

SPAIN Pfizer Av da. De Europa, 20b Parque Empresarial La Moraleja E-28108 Alcobendas Dectomax solution injectable 10 mg/ml Solution for injection Cattle and sheep Single dose 200 μg/kg bw Meat Cattle: 42 days Sheep: 60 days

SWEDEN Pfizer AB Box 501 S-183 25 Täby Dectomax vet 10 mg/ml Solution for injection Cattle, sheep, (reindeer) Not specified in the SPC Catt1e (and reindeer): 200 μg/kg bw (sc) Sheep: 200 μg/kg bw (sc or im) Meat: Cattle: 49 days Sheep: 45 days (im); 60 days (sc) Reindeer: 42 days Milk: Cattle: forbidden in lactating cows, not to be administered less than 60 days before calving Sheep: forbidden in lactating sheep, not to be administered less than 70 days before lambing

UNITED KINGDOM Pfizer Ltd Pfizer Ltd, Sandwich, Kent CT13 9NJ, United Kingdom Dectomax Injectable Solution for Cattle and Sheep 10mg/ml Solution for injection Sheep and cattle Not permitted for use in lactating ewes or cows used to produce milk for human consumption Not specified in the SPC Sheep: 300 μg/kg bw Cattle: 200 μg/kg bw Meat: Cattle: 70 days Sheep: 56 days Milk: Cattle: Do not use in dry dairy cows including pregnant heifers within 60 days before calving

ICELAND Pfizer A/S Vestre Gade DK-18 2650 Hvidovre Dextomax 1 % Solution for injection Cattle esp. bullocks, Not for use in lactating cows producing milk for human consumption, even in the resting period Sheep: Not for use in dairy ewes producing milk for human consumption. Not for use in pregnant ewes Pigs Single dose Cattle: 200 μg/kg bw (sc) Sheep: 200 μg/kg bw (sc, im) Pigs: 300 μg/kg bw Small pigs < 16 kg: < 4 kg: 0,1 ml 5-7 kg: 0,2 ml 8-10 kg: 0,3 ml 11-13 kg: 0,4 ml 14-16 kg: 0,5 ml Meat: Cattle: 45 days. Sheep: 35 days Milk: Cattle: Not to be used for pregnant cows 60 days before giving birth. Sheep: Not to be used in dairy ewes, for at least 70 days before giving birth, if the milk is going to be used for human consumption