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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,
, Revision: 18, Authorised, Last updated: 09/11/2021
ml) to be made up into a solution for infusion (drip) into … drip) into a vein, and as solutions for infusion (4 mg/100 ml … concentrate and 4 mg/100 ml solution is Zometa. Aclasta is the … -
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Veterinary medicine European public assessment report (EPAR): Meloxidolor
meloxicam, Horses; Dogs; Cattle; Cats; Pigs
Date of authorisation: 22/04/2013,, Revision: 9, Authorised, Last updated: 28/01/2022
meloxicam. It is available as a solution for injection (5 mg/ml, 20 … available as 5-mg/ml and 20-mg/ml solutions for injection, Meloxidolor … also available as a 40-mg/ml solution for injection. What is Meloxidolor … -
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Veterinary medicine European public assessment report (EPAR): Melovem
meloxicam, Pigs; Calves
Date of authorisation: 07/07/2009,, Revision: 5, Authorised, Last updated: 19/06/2014
meloxicam. It is available as a solution for injection (5 mg/ml, 20 … available as 5-mg/ml and 20-mg/ml solutions for injection, Melovem is … also available as a 30-mg/ml solution for injection. What is Melovem … -
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Human medicine European public assessment report (EPAR): Ibandronic acid Accord
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 14, Authorised, Last updated: 05/01/2023
calcium. Ibandronic acid Accord solution for injection is used to … acid Accord concentrate for solution for infusion (drip) is used … Accord is available as a solution for injection (3 mg) in a … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
concentrate to be made up into a solution for infusion (drip) into … 20 mg/ml concentrate for solution for infusion 2. QUALITATIVE … FORM Concentrate for solution for infusion (sterile concentrate … -
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Veterinary medicine European public assessment report (EPAR): Loxicom
meloxicam, Dogs; Cats; Cattle; Pigs
Date of authorisation: 10/02/2009,, Revision: 17, Authorised, Last updated: 10/02/2022
tablets (1 mg and 2.5 mg) and solutions for injection (5 mg/ml, and … acute disorders. Loxicom solution for injection (5 mg/ml) can … soft-tissue surgery. Loxicom solution for injection (20 mg/ml … -
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,, Revision: 15, Authorised, Last updated: 26/06/2023
swallowed with liquid and an oral solution to be drunk. It can only … less than 25 kg, the oral solution is recommended. For more … was not needed for the oral solution as the composition was sufficiently … -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 09/10/2023
powder to be made up into a solution for injection into a vein … When given into a vein, the solution is injected through a catheter … -
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 9, Authorised, Last updated: 09/02/2022
Atosiban SUN is available as a solution for injection and as a concentrate … concentrate that is made up into a solution for infusion (drip) into … Atosiban SUN is available as a solution for injection and as a concentrate … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
ml) to be used to make a solution for infusion (drip) into … drip) into a vein, and as a solution for infusion (4 mg/100 ml … ml) to be used to make a solution for infusion (drip) into … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 19, Authorised, Last updated: 21/04/2023
tablets should use an oral solution of lamivudine, or alternatively … with their kidneys. An oral solution of lamivudine can be used … tablets should use an oral solution of lamivudine, or alternatively … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
available as a 4mg/100ml solution for infusion (drip into a … a 4mg/5ml concentrate for solution for infusion. Zoledronic … available as a 4mg/100ml solution for infusion (drip into a … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 5, Authorised, Last updated: 13/01/2022
chemotherapy. It is available as a solution for injection or infusion … effect. In children, the solution should be given by infusion … chemotherapy. It is available as a solution for injection or infusion … -
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Human medicine European public assessment report (EPAR): Memantine Accord
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 03/12/2013,, Revision: 7, Authorised, Last updated: 13/01/2022
data on the medicine’s solubility, composition and absorption … -
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Human medicine European public assessment report (EPAR): Marixino (previously Maruxa)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 8, Authorised, Last updated: 08/12/2021
data on the medicine’s solubility, composition and absorption … -
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Veterinary medicine European public assessment report (EPAR): Rheumocam
meloxicam, Dogs; Horses; Cats; Cattle; Pigs
Date of authorisation: 10/01/2008,, Revision: 17, Authorised, Last updated: 18/11/2021
suspension, chewable tablets and a solution for injection. Injections … tablets for dogs, 5 mg/ml solution for injection for dogs and … and 20 mg/ml injection for solution for cattle, pigs and horses … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
powder to be made up into a solution for injection into a vein … When given into a vein, the solution is injected through a catheter … -
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 01/09/2021
powder to be made up into a solution for injection. The medicine … When given into a vein, the solution is given as a three- to five-second … Fresenius Kabi 1 mg powder for solution for injection 2. QUALITATIVE … -
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Veterinary medicine European public assessment report (EPAR): Inflacam
meloxicam, Horses; Dogs; Cats; Cattle; Pigs
Date of authorisation: 09/12/2011,, Revision: 12, Authorised, Last updated: 19/03/2021
chewable tablets and solution for injection . Injections … -
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Veterinary medicine European public assessment report (EPAR): Contacera
meloxicam, Horses; Pigs; Cattle
Date of authorisation: 06/12/2012,, Revision: 7, Authorised, Last updated: 16/04/2020
meloxicam. It is available as a solution for injection (20 mg/ml … meloxicam. It is available as a solution for injection (20 mg/ml … -
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 11, Authorised, Last updated: 14/11/2022
concentrate that is made up into a solution for infusion (drip into a … concentrate that is made up into a solution for infusion (drip into a … -
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Veterinary medicine European public assessment report (EPAR): Emdocam
meloxicam, Horses; Pigs; Cattle
Date of authorisation: 18/08/2011,, Revision: 9, Authorised, Last updated: 18/11/2021
liquid taken by mouth) and a solution for injection. Injections … investigate whether Emdocam solution for injection is absorbed … -
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Veterinary medicine European public assessment report (EPAR): Kriptazen
halofuginone, Calves, newborn
Date of authorisation: 08/02/2019,, Revision: 2, Authorised, Last updated: 20/10/2021
and is available as an oral solution (liquid to be given by mouth … Kriptazen 0.5 mg/ml oral solution for calves. 2. QUALITATIVE … PHARMACEUTICAL FORM Oral solution. Clear yellow solution. 4. CLINICAL PARTICULARS … -
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Veterinary medicine European public assessment report (EPAR): Halagon
halofuginone lactate, Calves, newborn
Date of authorisation: 13/12/2016,, Revision: 4, Authorised, Last updated: 18/10/2021
and is available as an oral solution (liquid to be given by mouth … Halagon is a water based oral solution containing the same The substance … and is available as an oral solution (liquid to be given by mouth … -
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 3, Authorised, Last updated: 20/02/2023
Dipharma is available as soluble tablets or as a powder, to … Dipharma is available as soluble tablets or as a powder, to …