Regulatory news2021-08-12T15:45:37+03:00

 

Regulatory news

 

Lizdexamfetamine dimesylate: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule – EMEA / H / N / PSR / S / 0033

By |November 16th, 2021|Categories: Regulatory news|Tags: |

Although the overall study results provide no evidence of increased cardiovascular risk, these overall estimates are derived from the study population, in which most patients had short-term LDX exposure. In an analysis of long-term LDX use, there was a higher estimated risk of MACE among LDX users compared to what [...]

Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule – PSUSA / 00010374/202101

By |November 16th, 2021|Categories: Regulatory news|Tags: |

Given the available data on interactions with duloxetine, childhood intoxication, and Brugada syndrome, PRAC considers the causal relationship between amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide and these risks at least a reasonable possibility. PRAC concluded that information about products containing amitriptyline, amitriptyline/amitriptylinoxide, and amitriptylinoxide should be changed accordingly. data source and details

Intravenous Iron preparation: CMDh Scientific Conclusions and Reasons for Deviations, Amendments to Product Information and Implementation Schedule – EMEA / H / N / PSR / J / 0026

By |November 13th, 2021|Categories: Regulatory news|Tags: |

Based on PRAC's review of the final PASS Study Report Version 1.1, PRAC believes that the condition of the PASS to further characterize the safety concerns about hypersensitivity reactions with respect to the safe and effective use of intravenous iron-containing medications can be removed. data source and details

Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN – Esomeprazole) 10 mg

By |November 13th, 2021|Categories: Regulatory news|Tags: , |

The following sections of the instructions for medical use of the drug have been amended; - "Side Effects." - The information has been updated. Information was added to subsection: "Skin and subcutaneous tissue disorders": acute generalized exanthematous pustulosis and drug rash with eosinophilia and systemic symptoms (DRESS syndrome) with an [...]

Warfarin – anticoagulant-related nephropathy

By |November 13th, 2021|Categories: Regulatory news|Tags: , |

PRAC analyzed pooled data from spontaneous case reports, clinical trials, and the literature regarding the risk of anticoagulant-associated nephropathy in patients receiving warfarin. PRAC has agreed that MAH of drugs containing warfarin should submit a change within 2 months of publication of the PRAC recommendation to change the product information [...]

Cefoperazone – Scientific Conclusions and Basis for Modification of Registration Approval Terms – PSUSA-00000597-202101 (Hematuria)

By |November 13th, 2021|Categories: Regulatory news|Tags: , |

In view of the available data on coagulopathy and bleeding from clinical trials, literature, spontaneous reports, and given a plausible mechanism of action, PRAC believes a causal relationship between cefoperazone and hematuria to be at least reasonably possible. PRAC concluded that information about products containing cefoperazone should be changed accordingly. [...]

5-fluorouracil (intravenous) – Scientific findings and reasons for changing the conditions of the marketing authorization – PSUSA-00000007-202012

By |November 9th, 2021|Categories: Regulatory news|Tags: |

Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that - the relationship between 5-fluorouracil (IV) and cutaneous lupus erythematosus - the relationship between 5-fluorouracil (IV) and stress cardiomyopathy (takotsubo [...]

Kazakhstan has introduced the practice of inspection of medical devices prior to state registration

By |November 8th, 2021|Categories: Regulatory news|Tags: , , , , |

Medical devices with a medium (e.g., sterile injectable medical devices), high (dental implants, stents), or very high (implantable pacemakers, absorbable suture material) potential risk of use are subject to inspection. The national regulatory agency inspects not only the functioning of the quality management system of medical devices but also evaluates [...]

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