Member State EU/EEA Applicant Name Pharmaceutical form INN/Strength Animal species Route of administration Recommended dose Withdrawal periods

Austria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Bulgaria Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Cyprus Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Czech Republic Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Denmark Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs – intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Estonia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Greece Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Spain Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Finland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

France Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution injectable pour bovins, ovins et porcins Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Hungary Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Ireland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Iceland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Latvia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Lithuania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Malta Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

The Netherlands Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Norway Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Poland Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Portugal Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Romania Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Sweden Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Prontax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.

Slovenia Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs Solution for injection Doramectin 10 mg/ml Cattle, sheep and pigs Cattle - subcutaneous Sheep and pigs - intramuscular Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days.