Архивы Regulatory news - Страница 2 из 3 - Национальный научный центр Фармаконадзора

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

Елена Матвеева2021-11-09T14:55:56+03:00

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 syndrome) - the relationship between [...]

5-fluorouracil (intravenous) — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000007-202012Елена Матвеева2021-11-09T14:55:56+03:00

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

Елена Матвеева2021-11-08T17:20:17+03:00

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 the measures taken by the [...]

Kazakhstan has introduced the practice of inspection of medical devices prior to state registrationЕлена Матвеева2021-11-08T17:20:17+03:00

Amiodarone — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000166-202012

Елена Матвеева2021-11-08T17:12:39+03:00

In view of the available data found in the literature and spontaneous reports, including those describing the chronology of drug interactions between Amiodarone and Sirolimus, leading to increased toxicity of Sirolimus, PRAC considers the estimated cumulative data to be sufficient to support a causal relationship. The PRAC concluded that the information on products containing Amiodarone [...]

Amiodarone — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000166-202012Елена Матвеева2021-11-08T17:12:39+03:00

The Council of the Eurasian Economic Commission approved the draft «On the Rules for the Regulation of the Circulation of Veterinary Medicines in the Customs Territory of the Eurasian Economic Union.»

Елена Матвеева2021-11-08T17:00:05+03:00

The Draft Decision states that: a) registration of veterinary medicinal products and other related procedures stipulated by the legislation of the member states of the Eurasian Economic Union, started and not completed as of the date of entry into force of clause 1 of this Decision, are carried out in accordance with the legislation of [...]

The Council of the Eurasian Economic Commission approved the draft «On the Rules for the Regulation of the Circulation of Veterinary Medicines in the Customs Territory of the Eurasian Economic Union.»Елена Матвеева2021-11-08T17:00:05+03:00

The marketing authorization holders of medicinal products registered in the Republic of Belarus in order to ensure the submission of the PSUR to the authorized body, as well as to maintain the PSUR submission procedure, are recommended:

Елена Матвеева2021-11-08T16:56:46+03:00

- starting from November 01, 2021, to submit the PSUR in accordance with the deadlines specified in the updated draft of the List, in electronic form with the possibility of text search in Belarusian, Russian, or English by e-mail to PSUR@rceth.by. PSUR sections (including a summary (resume) of the PSUR, an integrated analysis of the [...]

The marketing authorization holders of medicinal products registered in the Republic of Belarus in order to ensure the submission of the PSUR to the authorized body, as well as to maintain the PSUR submission procedure, are recommended:Елена Матвеева2021-11-08T16:56:46+03:00

Change in SMPC of methotrexate

Елена Матвеева2021-10-29T17:11:46+03:00

Data source and details Taking into account the available evidence from the published literature, EudraVigilance, and data provided by MAH, no definite causal relationship between methotrexate and Progressive Multifocal Leukoencephalopathy has been established, but the contribution of methotrexate to the development of Progressive Multifocal Leukoencephalopathy cannot be ruled out.

Change in SMPC of methotrexateЕлена Матвеева2021-10-29T17:11:46+03:00

Order of the Ministry of Health of the Republic of Belarus of September 23, 2021 No. 1161 On the implementation of a complex of preliminary technical works

Елена Матвеева2021-10-29T17:09:23+03:00

Order of the Ministry of Health of the Republic of Belarus No. 1161 dated September 23, 2021, approved the Regulations for the implementation of a complex of preliminary technical works preceding the state registration (re-registration) of medical devices and medical equipment Data source and details

Order of the Ministry of Health of the Republic of Belarus of September 23, 2021 No. 1161 On the implementation of a complex of preliminary technical worksЕлена Матвеева2021-10-29T17:09:23+03:00

New safety data for alemtuzumab

Елена Матвеева2021-10-29T17:07:44+03:00

New safety signal - Autoimmune encephalitisData source and details

New safety data for alemtuzumabЕлена Матвеева2021-10-29T17:07:44+03:00

On amendments to the general characteristics (SMPC) and instructions for medical use (leaflet, PIL) of medicinal products containing Perindopril as an active ingredient

Елена Матвеева2021-10-29T17:03:56+03:00

The instruction should include information about the Syndrome of inadequate secretion of ADH, depression, hot flashes, anuria/oliguria, acute liver failure data source and details

On amendments to the general characteristics (SMPC) and instructions for medical use (leaflet, PIL) of medicinal products containing Perindopril as an active ingredientЕлена Матвеева2021-10-29T17:03:56+03:00

In accordance with paragraph 2 of Article 3 of the Federal Law of December 27, 2019, No. 475-FZ «On Amendments to the Federal Law» On the Circulation of Medicines «and the Federal Law» On Amendments to the Federal Law «On the Circulation of Medicines», an updated (amended ) a list of interchangeable drugs.

Елена Матвеева2021-10-29T17:01:56+03:00

In accordance with paragraph 2 of Article 3 of the Federal Law of December 27, 2019, No. 475-FZ "On Amendments to the Federal Law" On the Circulation of Medicines "and the Federal Law" On Amendments to the Federal Law "On the Circulation of Medicines", an updated (amended ) a list of interchangeable drugs. data source [...]

In accordance with paragraph 2 of Article 3 of the Federal Law of December 27, 2019, No. 475-FZ «On Amendments to the Federal Law» On the Circulation of Medicines «and the Federal Law» On Amendments to the Federal Law «On the Circulation of Medicines», an updated (amended ) a list of interchangeable drugs.Елена Матвеева2021-10-29T17:01:56+03:00