5858 results
Keyword Naropina 5 Mg/ml Remove keyword
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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 … -
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Direct healthcare professional communication (DHPC): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg
Active substance: belatacept, DHPC type: Medication error, Last updated: 12/09/2022in maintenance dose from 5 mg/kg to 6 mg/kg Graft Rejection Kidney … in maintenance dose from 5 mg/kg to 6 mg/kg … maintenance dose from 5 mg/kg to 6 mg/kg Dear Healthcare professional … -
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Referral: Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard
fluconazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 01/12/2003, Last updated: 11/02/2004Fluconazol Tiefenbacher 50mg, 100 mg, 150 mg, 200 mg capsules, hard … Fluconazol Tiefenbacher 50mg, 100 mg, 150 mg, 200 mg capsules, hard … Fluconazol Tiefenbacher 50 mg, 100 mg, 150 mg, 200 mg capsules, hard, INN-Fluconazole … -
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Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets … Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The … Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh … -
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National expert: Simona Jurkovic Mlakar, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (updated)
- Declaration of interests - 39.32 KB | PDF
- Curriculum Vitae - 46.43 KB | PDF
Simona Jurkovic Mlakar … Simona Jurkovic Mlakar … information Simona Jurkovic Mlakar Work experience … -
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News: Public statement on Insuman Infusat 100-IU/ml solution for injection in cartridges of 3.15 ml (insulin human) - Risk of leakage during use
Last updated: 14/02/2000on Insuman Infusat 100-IU/ml solution for injection in … injection in cartridges of 3.15 ml (insulin human) - Risk of … GmbH. Insuman Infusat 100-IU/ml solution for injection in … -
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Referral: Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys
Amoxicillin trihydrate, Article 33
Status: European Commission final decision, opinion/position date: 04/11/2015, EC decision date: 07/01/2016, Last updated: 05/02/2016Solamocta 697 mg/g powder for use in drinking … medicinal product Solamocta 697 mg/g Powder for Use in Drinking … information. What is Solamocta 697 mg/g Powder for Use in Drinking … -
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Direct healthcare professional communication (DHPC): Metalyse (tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution for injection: temporary supply shortage
Active substance: tenecteplase, DHPC type: Medicine shortage, Last updated: 23/09/2022tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution … tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution … tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution … -
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Referral: Strenzen 500/125-mg/g powder
amoxicillin, clavulanic acid, Article 33
Status: European Commission final decision, opinion/position date: 10/04/2013, EC decision date: 12/08/2013, Last updated: 19/09/2013Strenzen 500/125-mg/g powder … Overview Strenzen 500/125-mg/g powder for use in drinking … procedure for Strenzen 500/125-mg/g powder for use in drinking … -
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Referral: Ecomectin 18.7mg/g Oral Paste for Horses
ivermectin, Article 33
Status: European Commission final decision, opinion/position date: 08/11/2007, EC decision date: 17/01/2008, Last updated: 07/12/2011Ecomectin 18.7mg/g Oral Paste for Horses … decision Overview Ecomectin 18.7 mg/g Oral Paste for Horses is … endectocides. Ecomectin 18.7 mg/g Oral Paste for Horses is … -
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Referral: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006Lansoprazol-ratiopharm 15 mg and 30 mg … Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to … section of the SPCs. For the 15 mg dosage form the therapeutic … -
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Referral: Lansopon 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 13/10/2005Lansopon 15 mg and 30 mg … Authorisation for Lansopon (15 mg and 30 mg) was previously granted to … referral for Lansopon 15 mg and 30 mg International Non-Proprietary … -
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Referral: Lansoprazol HEXAL 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 15/09/2005Lansoprazol HEXAL 15 mg and 30 mg … for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to … for Lansoprazol HEXAL 15 mg and 30 mg International Non-Proprietary … -
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Referral: Lansoprazol AbZ-Pharma 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006Lansoprazol AbZ-Pharma 15 mg and 30 mg … Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to … Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary … -
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Referral: Lansoprazol CT-Arzneimittel 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006nsoprazol CT-Arzneimittel 15 mg and 30 mg … Lansoprazol CT-Arzneimittel 15 mg and 30 mg International Non-Proprietary … Lansoprazol CT-Arzneimittel (15 mg and 30 mg) was previously granted to … -
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Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance
Last updated: 22/09/2021Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence … Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence … Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence …
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Direct healthcare professional communication (DHPC): Neofordex 40 mg (dexamethasone): removal of the score-line and the associated 20 mg posology
Active substance: dexamethasone, DHPC type: Change in dosing recommendation, Last updated: 17/02/2023Neofordex 40 mg (dexamethasone): removal … score-line and the associated 20 mg posology Multiple Myeloma … Neofordex 40 mg (dexamethasone): removal … -
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Direct healthcare professional communication (DHPC): SIMULECT (basiliximab): Do not use WFI ampoules co-packed with vials of sterile freeze-dried powder of Simulect 10mg and 20mg
Active substance: basiliximab, DHPC type: Quality defect, Last updated: 21/04/2023freeze-dried powder of Simulect 10mg and 20 mg Graft Rejection Kidney … freeze-dried powder of Simulect 10mg and 20 mg … freeze-dried powder of Simulect 10mg and 20 mg Dear Healthcare Professional … -
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Referral: Doxastad 4 mg
Doxazosin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/06/2006, EC decision date: 11/10/2006, Last updated: 11/10/2006Doxastad 4 mg … decision Overview Doxastad 4 mg prolonged release tablets … recognition of Doxastad 4 mg prolonged release tablets … -
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Referral: Crestor 5 mg
rosuvastatin calcium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Crestor 5 mg … Authorisation for Crestor (10 to 40 mg) was originally granted to … committed to apply for a 5-mg dose of rosuvastatin together … -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021co-packed with Respreeza 4.000 mg and 5.000 mg Genetic Diseases, Inborn Lung … co-packed with Respreeza 4.000 mg and 5.000 mg … co-packed with Respreeza 4.000 mg and 5.000 mg Dear Healthcare professional … -
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Referral: Doxyprex 100mg Premix
Doxycycline, Article 33
Status: European Commission final decision, opinion/position date: 14/02/2007, EC decision date: 22/05/2007, Last updated: 07/12/2011Doxyprex 100mg Premix … decision Overview Doxyprex 100 mg premix presented in 5 kg … 25 kg bags containing 100 mg/g doxycycline base as hyclate … -
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Referral: Bicalutamide 150 mg
bicalutamide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/05/2007, EC decision date: 03/09/2007, Last updated: 03/10/2007Bicalutamide 150 mg … medicines containing 150 mg bicalutamide, used orally … containing bicalutamide 150 mg, both those that are authorised … -
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Referral: Doxazosin "Winthrop" 4mg
Doxazosin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/06/2006, EC decision date: 11/10/2006, Last updated: 11/10/2006Doxazosin "Winthrop" 4mg … Doxazosin “Winthrop” 4 mg prolonged release tablets … Doxazosin “Winthrop” 4 mg prolonged release tablets …