5811 results
Keyword Naropina 5 Mg/ml Remove keyword
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Referral: Ketabel 100 mg/ml solution for injection and associated names
ketamine, associated names: Ketabel vet. 100 mg/ml solution for injection, Belatamin 100 mg/ml solution for injection, Belatamin vet. 100 mg/ml solution for injection, Article 33
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 04/03/2020, Last updated: 16/04/2020Ketabel 100 mg/ml solution for injection and … the medicine Ketabel 100 mg/ml solution for injection and … injection and contains 100 mg ketamine as active substance … -
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Referral: Prontax 5 mg/ml pour-on solution for cattle
doramectin, associated names: Dectomax 5 mg/ml pour-on Solution for cattle, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 5 mg/ml pour-on solution for cattle … decision Overview Prontax 5 mg/ml pour-on solution for cattle … benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle … -
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Referral: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
doramectin, associated names: Dectomax 10 mg/ml solution for injection for cattle sheep and pigs, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 10 mg/ml solution for injection for … decision Overview Prontax 10 mg/ml solution for injection for … benefit-risk profile of Prontax 10 mg/ml solution for injection for … -
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide is a salicylanilide … suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide is a salicylanilide … Galway Ireland Chanil 34 mg/ml Oral Suspension for Cattle … -
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Referral: Denagard 45%
tiamulin hydrogen fumarate, associated names: Tiamutin 45%, Denagard 450 mg/g, Denagard vet 450 mg/g, Article 34
Status: European Commission final decision, opinion/position date: 12/04/2017, EC decision date: 14/07/2017, Last updated: 11/08/2017drinking water and contains 450 mg tiamulin hydrogen fumarate … Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium … Tiamutin 45% Denagard 450 mg/g Denagard vet 450 … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011substance doxycycline hyclate 500 mg/g. The product is indicated … 50%doxycycline hyclate Soludox 500 mg/g Soludox Vet Soludox 433 mg/g Doxy Ort 50% EMA/512470/2011 … substance doxycycline hyclate 500 mg/g. The product is indicated … -
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Withdrawn application: Ximelagatran 36 mg film coated tablets
date of withdrawal: 14/02/2006, Initial authorisation, Last updated: 16/02/2006Ximelagatran 36 mg film coated tablets: Withdrawn … XIMELAGATRAN ASTRAZENECA 36 MG FILM COATED TABLETS International … authorisation for Ximelagatran 36 mg film coated tablets, for … -
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Orphan designation: Adeno-associated virus of serotype rh10 encoding Human MLC1 under the control of GFAP promoter for: Treatment of megalencephalic leukoencephalopathy with subcortical cysts
Date of designation: 15/10/2021, Positive, Last updated: 11/11/2022serotype rh10 encoding Human MLC1 under the control of GFAP … leukoencephalopathy with subcortical cysts (MLC) in the European Union on … expected to work Patients with MLC lack a brain protein called … -
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Summary of opinion: Suvaxyn PRRS MLV
porcine respiratory and reproductive syndrome virus, live, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023Suvaxyn PRRS MLV: Pending EC decision … Suvaxyn PRRS MLV … post-authorisation) Suvaxyn PRRS MLV Common name: Porcine respiratory … -
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Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof
dinoprost, Article 35
Status: European Commission final decision, opinion/position date: 18/06/2020, EC decision date: 16/09/2020, Last updated: 06/10/2020Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020Cabazitaxel Accord 20 mg/mL concentrate for solution … and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for … Cabazitaxel Accord 20 mg/mL concentrate for solution … -
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Veterinary medicine European public assessment report (EPAR): Suvaxyn PRRS MLV
Modified live porcine respiratory and reproductive syndrome virus, Pigs
Date of authorisation: 24/08/2017, Revision: 4, Authorised, Last updated: 09/09/2020Suvaxyn PRRS MLV … Suvaxyn PRRS MLV … assessment report for Suvaxyn PRRS MLV (EMEA/V/C/004276/0000 … -
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Referral: Norbonex 5 mg/ml pour-on solution for beef and dairy cattle
eprinomectin, Article 33
Status: European Commission final decision, opinion/position date: 15/01/2014, EC decision date: 21/03/2014, Last updated: 14/05/2014Norbonex 5 mg/ml pour-on solution for beef … decision Overview Norbonex 5 mg/ml pour-on solution for beef … procedure for Norbonex 5 mg/ml Pour-on solution for beef … -
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Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof
Amoxicillin trihydrate, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 12/11/2020Betamox LA 150 mg/ml suspension for injection … mg/ml suspension for injection … -
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Referral: Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
azaperone, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 30/10/2020Stresnil 40 mg/ml solution for injection for … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Valbazen 100 mg/ml Total Spectrum Wormer oral … for cattle for Valbazen 100 mg/ml Total Spectrum Wormer oral … periods for Valbazen 100 mg/ml Total Spectrum Wormer oral … -
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Direct healthcare professional communication (DHPC): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023albumin bound nanoparticles) 5 mg/ml powder for dispersion for … albumin bound nanoparticles) 5 mg/ml powder for dispersion for … albumin-bound nanoparticles / 5 mg/ml powder for dispersion for … -
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Referral: Suifertil 4-mg/ml oral solution for pigs and associated names
altrenogest, associated names: Synchroplan, Article 33
Status: European Commission final decision, opinion/position date: 18/07/2013, EC decision date: 02/10/2013, Last updated: 30/10/2013Suifertil 4-mg/ml oral solution for pigs and … decision Overview Suifertil 4-mg/ml oral solution for pigs contains … procedure for Suifertil 4-mg/ml oral solution for pigs and … -
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Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with … Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with … NUBRIVEO®) (BRIVARACETAM 10MG/ML) ORAL SOLUTION: BOTTLES WITH … -
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Press release: European Medicines Agency recommends discontinuation of Vimpat 15-mg/ml syrup
CHMP, Last updated: 22/09/2011discontinuation of Vimpat 15-mg/ml syrup … discontinuation of Vimpat 15-mg/ml syrup … discontinuation of Vimpat 15mg/ml syrup Vimpat 15 mg/ml syrup no longer available … -
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Press release: European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup
CHMP, Last updated: 22/07/2011agrees to recall of Vimpat 15-mg/ml syrup … to a recall of Vimpat 15 mg/ml syrup because of a quality … of an application for a 10-mg/ml syrup for Vimpat to continue … -
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Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe
Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021Eylea 40 mg/mL (aflibercept solution for … Eylea 40 mg/mL (aflibercept solution for … Communication EYLEA 40 mg/mL (aflibercept solution for … -
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Direct healthcare professional communication (DHPC): Supply shortage of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002)
Active substance: rasburicase, DHPC type: Medicine shortage, Last updated: 17/02/2023Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate … Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate … Fasturtec® (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate … -
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Direct healthcare professional communication (DHPC): RoActemra (tocilizumab): Temporary supply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL concentrate for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patient
Active substance: tocilizumab, DHPC type: Medicine shortage, Last updated: 02/09/2021Temporary supply shortage for 162 mg solution for subcutaneous … injection and RoActemra 20 mg/mL concentrate for solution … Temporary supply shortage for 162 mg solution for subcutaneous … -
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Direct healthcare professional communication (DHPC): Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes
Active substance: lopinavir, ritonavir, DHPC type: Quality defect, Last updated: 04/01/2021bottle pack containing 2-ml oral dosing syringes: Presence … Presence of amide particles in 2-ml oral dosing syringes HIV … bottle pack containing 2-ml oral dosing syringes: Presence …