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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 1-17 of 17 matching medicines

Product listings were last updated on 27/11/2022
Trade Name Licence Number & Holder Documents
Tolfedine 4% w/v Solution for Injection for dogs and cats
Solution for injection

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VPA10983/019/001
Authorised: 12/08/1993
Vetoquinol Ireland Limited
SPC IPAR Variations
Tolfedine 6 mg tablets
Tablet

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VPA10983/018/001
Authorised: 12/08/1993
Vetoquinol Ireland Limited
SPC IPAR Variations
Tolfedine 60 mg tablets
Tablet

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VPA10983/018/002
Authorised: 12/08/1993
Vetoquinol Ireland Limited
SPC IPAR Variations
TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs
Solution for injection

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VPA10790/006/001
Authorised: 21/08/2015
SP Veterinaria, S.A.
SPC IPAR
Tolfine
Solution for injection

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VPA10983/031/001
Authorised: 04/02/2000
Vetoquinol Ireland Limited
SPC IPAR Variations
Tolfine 80 mg/ml solution for injection for cattle
Solution for injection

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VPA10983/064/001
Authorised: 26/08/2022
Vetoquinol Ireland Limited
SPC IPAR
Tolracol 50 mg/ml oral suspension for pigs, cattle and sheep
Oral suspension

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VPA10774/026/001
Authorised: 05/12/2014
Krka, d.d., Novo mesto
SPC IPAR
Toltarox 50 mg/ml oral suspension for cattle
Oral suspension

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VPA10774/007/002
Authorised: 15/11/2013
Krka, d.d., Novo mesto
SPC IPAR Variations
Toltarox 50 mg/ml oral suspension for pigs
Oral suspension

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VPA10774/007/001
Authorised: 24/09/2010
Krka, d.d., Novo mesto
SPC IPAR Variations
TOPIMEC 0.8 mg/ml Oral Solution for Sheep
Oral solution

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VPA10987/080/001
Authorised: 17/07/2009
Chanelle Pharmaceuticals Manufacturing Limited
SPC IPAR Variations
Topimec 5 mg/ml Pour-on Solution
Pour-on solution

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VPA10987/159/001
Authorised: 13/05/2005
Chanelle Pharmaceuticals Manufacturing Limited
SPC Variations
Topimec Injection 10 mg/ml solution for injection
Solution for injection

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VPA10987/157/001
Authorised: 04/02/2005
Chanelle Pharmaceuticals Manufacturing Limited
SPC Variations
Topimec Super Solution for Injection
Solution for injection

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VPA10987/099/001
Authorised: 14/10/2011
Chanelle Pharmaceuticals Manufacturing Limited
SPC IPAR Variations
Torbugesic 10 mg/ml Solution for Injection
Solution for injection

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VPA10387/079/001
Authorised: 01/10/2000
Zoetis Belgium S.A.
SPC
Torbuphanol Vet 10 mg/ml solution for injection for injection for horses, dogs and cats
Solution for injection

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VPA10387/080/001
Authorised: 09/11/2012
Zoetis Belgium S.A.
SPC IPAR
Torphadine 10 mg/ml solution for injection for dogs, cats and horses
Solution for injection

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VPA10475/038/001
Authorised: 28/10/2016
Le Vet Beheer B.V.
SPC
Toxovax
Concentrate and solvent for suspension for injection

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VPA10996/080/001
Authorised: 18/08/2003
Intervet Ireland Limited
SPC