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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


  • Veterinary Medicines
 
 

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Latest list of Authorised or Transfer Pending Products
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Showing 1-20 of 116 matching medicines

Product listings were last updated on 29/05/2023
Trade Name Licence Number & Holder Documents
DACLOTRIX 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg
Spot-on solution

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VPA10774/074/003
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
DACLOTRIX 200 mg/40 mg spot-on solution for dogs up to 4 kg
Spot-on solution

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VPA10774/074/001
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
DACLOTRIX 2000 mg/400 mg spot-on solution for dogs over 25 kg
Spot-on solution

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VPA10774/074/004
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
DACLOTRIX 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg
Spot-on solution

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VPA10774/074/002
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Solution for injection

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VPA10836/009/001
Authorised: 13/09/2019
FATRO S.p.A.
SPC
DALMARELIN, 25 micrograms/ml, solution for injection for cattle and rabbits
Solution for injection

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VPA10836/002/001
Authorised: 19/03/2004
FATRO S.p.A.
SPC Variations
Dalmazin 75 micrograms/ml solution for injection for cows and sows
Solution for injection

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VPA10836/001/001
Authorised: 13/10/2000
FATRO S.p.A.
SPC Variations
Damtix 1250 mg/250 mg spot-on solution for dogs over 10 kg up to 25 kg
Spot-on solution

Compare
VPA10774/073/003
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
Damtix 200 mg/40 mg spot-on solution for dogs up to 4 kg
Spot-on solution

Compare
VPA10774/073/001
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
Damtix 2000 mg/400 mg spot-on solution for dogs over 25 kg
Spot-on solution

Compare
VPA10774/073/004
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
Damtix 500 mg/100 mg spot-on solution for dogs over 4 kg up to 10 kg
Spot-on solution

Compare
VPA10774/073/002
Authorised: 01/04/2022
Krka, d.d., Novo mesto
SPC IPAR Variations
Deccox 60.6 g/kg Premix for Medicated Feeding Stuff
Premix for medicated feeding stuff

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VPA10387/018/001
Authorised: 01/10/1989
Zoetis Belgium S.A.
SPC
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
Solution for injection

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VPA10387/019/001
Authorised: 09/12/2012
Zoetis Belgium S.A.
SPC IPAR Variations
Dectomax 5 mg/ml Pour-On Solution for Cattle
Pour-on solution

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VPA10387/020/001
Authorised: 09/12/2013
Zoetis Belgium S.A.
SPC Variations
Dectospot 10 mg/ml Pour-on Solution for Cattle and Sheep
Pour-on solution

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VPA22033/058/001
Authorised: 12/02/2016
Bimeda Animal Health Limited
SPC Variations
Defendog Cutaneous solution
Cutaneous solution

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VPA10988/053/001
Authorised: 13/06/1997
Virbac S.A.
SPC
Delta Apomorphine Hydrochloride Solution for Injection 3 mg/ml
Solution for injection

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VPA10793/001/001
Authorised: 31/03/2006
Acravet Ltd
SPC
Deltadot 10 mg/ml Pour-on Solution for Cattle and Sheep
Pour-on solution

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VPA22033/008/001
Authorised: 23/09/2016
Bimeda Animal Health Limited
SPC IPAR Variations
Deltanil 10 mg/ml Pour-on Solution for cattle and sheep
Pour-on solution

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VPA10988/087/001
Authorised: 28/03/2014
Virbac S.A.
SPC
Delvosteron 100 mg/ml Suspension for Injection
Suspension for injection

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VPA10996/065/001
Authorised: 01/10/1987
Intervet Ireland Limited
SPC