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Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

  • 7 декабря 2019
  • acceptable, active substance, AI, API, authority, cancer, carcinogen, CEP, daily, diabetes, drug, drug product, EDQM, EMA, EU, FDA, GMP, HCl, human, hydrochloride, ICH M7, impurity, intake, investigation, manufacturing process, medicinal product, medicines, metformin, N-nitrosodimethylamine, NDMA, nitrosamine, root cause, type 2,
  EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. At this point, there are no data indicating that EU metformin medicines are affected. Authorities in the EU are in the process of working with companies to test EU
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First non-injectable treatment for severe hypoglycaemia!

  • 30 октября 2019
  • administration, Baqsimi, centralised procedure, CHMP, CP, demonstration, device, diabetes, dispenser, Eli Lilly Nederland B.V., EMA, EU, formulation, glucagon, glucose, hypoglycaemia, instructional, insulin, kit, leaflet, low blood sugar level, MA, MAH, marketing authorization, measures, medicinal product, minimization, nasal powder, non-injectable, novel, pharmaceutical, risk, severe, single-use, training, treatment, video,
On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation in the European Union for the medicinal product Baqsimi, intended for the treatment of severe hypoglycaemia. It is the first treatment for severe hypoglycaemia (low blood sugar levels) that can be
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Esketamine (Spravato) with the positive CHMP opinion for combination treatment in adults with treatment-resistant major depressive disorder

  • 23 октября 2019
  • adult, antidepressant, CAP, centralised procedure, CHMP, combination, CP, depression, depressive, disorder, EMA, esketamine, EU, Janssen-Cilag International N.V., MA, MAH, major, marketing authorization, medicinal product, nasal spray solution, SNRI, Spravato, SSRI, TRD, treatment, treatment-resistant,
On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spravato, intended for combination treatment in adults with treatment-resistant major depressive disorder. The applicant for this medicinal product is Janssen-Cilag International N.V. Source: EMA
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Nitrosamines in human medicines – consequences for MAHs

  • 7 октября 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, analysis, API, ASMF, authorities, cancer, candesartan, carcinogen, CEP, change, chemically synthesized, CHMP, competent, confirmatory, contamination, cross-contamination, detection, DIPNA, drug product, EIPNA, EMA, evaluation, finished product, formation, generics, GMP, HCl, human, hydrochloride, ICH M7, impurity, interim, irbesartan, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing authorisation, marketing authorisation holder, medicinal product, medicines, method, MIA, mitigate, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, non-sartans, olmesartan, OTC, pioglitazone, process, public health, ranitidine, referral procedure, review, risk, sartans, specific ring structure, temporary, test, testing, tetrazole, valsartan, variation,
EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities
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“Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” published by EMA will come into force on 1 October 2019 (Part II)

  • 30 сентября 2019
  • active substance, API, aseptic processing, ATMP, cell based medicinal products, container, decision tree, documentation, dossier, EMA, excipients, filtration, finished dosage form, finished product, GMP, medicinal product, part, Ph. Eur., post-aseptic processing terminal heat treatment, primary, quality, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,
  On 8 March 2019, the European Medicines Agency (EMA) published final version of Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. This guideline will come into force on 1 October 2019.       Guidance is also provided on the documentation expected for sterile finished products, sterile active
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Review of widely used ranitidine medicines to treat conditions such as heartburn and stomach ulcers due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen!

  • 23 сентября 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, API, Article 31, benefit-risk balance, cancer, candesartan, carcinogen, CEP, cimetidine, detection, DIPNA, drug product, EC, EDQM, EIPNA, EMA, esomeprazole, European Commission, famotidine, FDA, finished product, HCl, heartburn, histamine receptors blocker, human, hydrochloride, ICH M7, impurity, irbesartan, lansoprazole, LC-MS, limit, losartan, MA, MAH, medicinal product, medicines, method, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, Nexium, nitrosamine, nizatidine, NMBA, olmesartan, omeprazole, OTC, Pepcid, Prevacid, Prilosec, ranitidine, referral procedure, review, root cause, sartans, specific ring structure, stomach, Tagamet, tetrazole, ulcers, valsartan,
  EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA) at levels which raise concerns according to the principles of the ICH M7 guideline. The results on a limited sample of products showed that for the majority of both ranitidine APIs
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs

  • 29 августа 2019
  • agreement, batch, consequence, EC, EU, FDA, GMP, human, implication, inspection, manufacturer, manufacturing, medicines, milestone, MRA, Mutual Recognition Agreement, phase, QP, site, testing, transition, US, USA, waiver,
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. It means that the US Food and
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The first cannabidiol containing medicinal product with a positive opinion in the EU centralised procedure!

  • 22 августа 2019
  • cannabidiol, cannabis, CBD, centralised procedure, CHMP, clobazam, CP, Dravet syndrome, DS, EMA, Epidyolex, epilepsy, EU, GW Pharma (International) B.V., Lennox-Gastaut syndrome, LGS, MA, MAH, marketing authorization, medicinal product, oral solution, orphan designation, orphan medicine, seizures,
On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epidyolex, intended for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), two forms of epilepsy. The applicant for this medicinal product is
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“Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products (ATIMPs) in clinical trials” in the consultation phase

  • 8 июля 2019
  • analysis, animal, ATIMP, ATMP, cell, clinical, confirmatory, CT, CTD, development, dossier, early, editing, efficacy, EMA, exploratory, FIH, FIM, gene, genetic, genome, guideline, healthy, IMP, IMPD, late, MA, manipulation, manufacturing, model, modification, Module 3, multidisciplinary, non-cellular, non-clinical, patient, phase, population, protocol, QC, quality, quality control, requirements, risk, safety, study, subject, trial, type, vector, volunteer,
On 21 February 2019, the European Medicines Agency (EMA) has published the draft Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials. The public consultation phase will last until 1 August 2019. The main objective of this guideline is to avoid discrepancies across the EU regarding the requirements
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Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VIII)

  • 29 мая 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, active substance, angiotensin-II-receptor antagonists, angiotensin-II-receptor blockers, API, ARBs, Article 31, azilsartan, cancer, candesartan, carcinogen, CEP, conditions to MA, diabetes, DIPNA, drug product, EC, EDQM, EIPNA, EMA, eprosartan, European Commission, Hetero Labs, human, hypertension, impurity, interim, investigation, irbesartan, legally binding decision, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing process, manufacturing site, marketing authorisation holder, medicinal product, medicines, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, olmesartan, pioglitazone, review, root cause, sartans, scientific conclusion, specific ring structure, suspension, telmisartan, temporary, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,
  On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers, ARBs) review their manufacturing processes so that they do not produce nitrosamine impurities. An initial investigation report on the root cause of the presence of N-nitrosodimethylamine (NDMA) provided by Zhejiang Huahai Pharmaceutical, China upon
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