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For Summary of Product Characteristics (SPCs) of new products that have been granted a marketing authorisation since February 2022 in accordance with Regulation 2019/6, the format and content of the SPC has changed compared to those issued beforehand. In particular sections 7, 8, 9 and 10 (specifying information on the marketing authorisation holder, marketing authorisation number, date of first authorisation and date of revision of the text) are not included in the SPC document itself (these fields appear blank), as this information is provided on the national-specific product information landing page of the website (from which you click through to the SPC document itself).

The HPRA advises healthcare professionals not to retain printed versions of SPC documents, as these documents are subject to change and updating, including changes to safety and dose related information. We recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about the SPCs on our website e-mail vetinfo@hpra.ie


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Latest list of Authorised or Transfer Pending Products
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Showing 61-80 of 156 matching medicines

Product listings were last updated on 27/11/2022
Trade Name Licence Number & Holder Documents
Alpramil 20 mg/200 mg tablets for dogs weighing at least 8 kg
Tablet

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VPA10980/018/003
Authorised: 14/04/2022
Alfasan Nederland B.V
SPC
Alpramil 4 mg/10 mg film-coated tablets for cats weighing at least 0.5 kg
Film-coated tablet

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VPA10980/017/001
Authorised: 14/04/2022
Alfasan Nederland B.V
SPC
Alpramil 5 mg/50 mg tablets for dogs weighing at least 0.5 kg
Tablet

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VPA10980/018/001
Authorised: 14/04/2022
Alfasan Nederland B.V
SPC
Altidox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys
Powder for use in drinking water

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VPA10989/068/001
Authorised: 21/10/2016
Eurovet Animal Health B.V.
SPC
Altresyn 4 mg/ml oral solution for pigs
Oral solution

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VPA10815/010/001
Authorised: 06/02/2009
Ceva Santé Animale
SPC Variations
Aludex 50 g/l Concentrate for cutaneous solution
Concentrate for cutaneous solution

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VPA10996/101/001
Authorised: 01/10/1999
Intervet Ireland Limited
SPC
Aluspray 4% w/w Cutaneous Spray, Powder
Cutaneous spray, powder

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VPA10983/020/001
Authorised: 01/10/1989
Vetoquinol Ireland Limited
SPC IPAR
Alvebuton 100 mg/ml Solution for injection for cattle, pigs, horses, sheep, goats
Solution for injection

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VPA16142/003/001
Authorised: 24/03/2017
V.M.D. n.v.,
SPC
Alvegesic vet. 10 mg/ml Solution for injection for Horses, Dogs and Cats
Solution for injection

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VPA16142/002/001
Authorised: 04/09/2009
V.M.D. n.v.,
SPC
Alzane 5 mg/ml, solution for injection for dogs and cats
Solution for injection

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VPA10495/001/001
Authorised: 28/10/2011
Laboratorios SYVA, S.A.U
SPC
Amatib 800 mg/g oral powder for pigs and chickens
Powder for use in drinking water

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VPA10774/045/001
Authorised: 21/08/2015
Krka, d.d., Novo mesto
SPC IPAR Variations
Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg
Film-coated tablet

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VPA10774/059/004
Authorised: 17/09/2021
Krka, d.d., Novo mesto
SPC IPAR Variations
Amcofen 12.5/125.0 mg chewable tablets for dogs weighing at least 5 kg
Chewable tablet

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VPA10774/059/002
Authorised: 27/07/2018
Krka, d.d., Novo mesto
SPC IPAR
Amcofen 16 mg/40 mg chewable tablets for cats weighing at least 2 kg
Chewable tablet

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VPA10774/060/002
Authorised: 27/07/2018
Krka, d.d., Novo mesto
SPC IPAR Variations
Amcofen 2.5 mg/25 mg chewable tablets for small dogs and puppies weighing at least 0.5 kg
Chewable tablet

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VPA10774/059/001
Authorised: 27/07/2018
Krka, d.d., Novo mesto
SPC IPAR
Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg
Film-coated tablet

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VPA10774/059/003
Authorised: 17/09/2021
Krka, d.d., Novo mesto
SPC IPAR Variations
Amcofen 4 mg/10 mg chewable tablets for small cats and kittens weighing at least 0.5 kg
Chewable tablet

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VPA10774/060/001
Authorised: 27/07/2018
Krka, d.d., Novo mesto
SPC IPAR Variations
Amflee 2.5 mg/ml cutaneous spray, solution for cats and dogs
Cutaneous spray, solution

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VPA10774/022/001
Authorised: 22/02/2013
Krka, d.d., Novo mesto
SPC
Amflee Combo 134 mg/120.6 mg spot-on solution for medium dogs
Spot-on solution

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VPA10774/051/002
Authorised: 06/07/2018
Krka, d.d., Novo mesto
SPC IPAR
Amflee Combo 268 mg/241.2 mg spot-on solution for large dogs
Spot-on solution

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VPA10774/051/003
Authorised: 06/07/2018
Krka, d.d., Novo mesto
SPC IPAR