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138 results
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Summary of opinion: Velactis
cabergoline, opinion date: 05/12/2019, Negative, Last updated: 06/12/2019 -
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Summary of opinion: Rabitec
Rabies vaccine (live, oral) for foxes and raccoon dogs, opinion date: 23/01/2020, Positive, Last updated: 24/01/2020 -
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Summary of opinion: Clynav
Salmon pancreas disease vaccine (recombinant DNA plasmid), opinion date: 20/02/2020, Positive, Last updated: 21/02/2020 -
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Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury
Active substance: metamizole, DHPC type: Periodic safety update report, Last updated: 15/12/2020 -
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Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine
Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 -
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Summary of opinion: Daxocox
enflicoxib, opinion date: 17/02/2021, Positive, Last updated: 19/02/2021 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020 -
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Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy
Active substance: leuprorelin, DHPC type: Referral - Article 31, Last updated: 02/10/2020 -
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Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams
Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020 -
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Summary of opinion: Zulvac BTV
Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3), opinion date: 20/05/2020, Positive, Last updated: 25/05/2020 -
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Summary of opinion: Vectormune FP ILT
Fowlpox and avian infectious laryngotracheitis vaccine (live, recombinant), opinion date: 07/10/2020, Positive, Last updated: 09/10/2020 -
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Summary of opinion: Frontpro (previously known as Afoxolaner Merial)
afoxolaner, opinion date: 09/09/2021, Positive, Last updated: 10/09/2021 -
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Summary of opinion: Cytopoint
lokivetmab, opinion date: 09/09/2020, Positive, Last updated: 11/09/2020 -
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Summary of opinion: Ultifend ND IBD
Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant), opinion date: 17/02/2021, Positive, Last updated: 19/02/2021 -
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Summary of opinion: Leucofeligen FeLV/RCP
feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated), opinion date: 25/05/2020, Positive, Last updated: 25/05/2020 -
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Summary of opinion: Strangvac
Streptococcus equi vaccine (recombinant proteins), opinion date: 17/06/2021, Positive, Last updated: 18/06/2021 -
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Direct healthcare professional communication (DHPC): Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction
Active substance: mifamurtide, DHPC type: Quality defect, Last updated: 25/02/2020 -
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Summary of opinion: CircoMax
Porcine circovirus vaccine (inactivated recombinant), opinion date: 04/11/2021, Positive, Last updated: 08/11/2021 -
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Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk
Active substance: ulipristal acetate, DHPC type: Interim measures, Last updated: 23/03/2020 -
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Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Champix (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the Pfizer acceptable daily intake limit
Active substance: varenicline, DHPC type: Quality defect, Last updated: 15/07/2021 -
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Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021 -
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Direct healthcare professional communication (DHPC): INOmax (nitric oxide): Difficulties in closing the cylinder valves after use: precautions for use when disconnecting the cylinders from pressure regulators
Active substance: Nitric oxide, DHPC type: Quality defect, Last updated: 03/06/2021