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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

Golikova proposed to centrally purchase medicines for hospitals
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Golikova proposed to centrally purchase medicines for hospitals

Елена Матвеева2021-10-29T17:06:13+03:00

Deputy Prime Minister Tatyana Golikova proposed to provide for the possibility of centralized procurement of expensive drugs for hospitals. She stated this at the presidium of the government's coordinating council to combat coronavirus, writes RIA Novosti. “We propose to consider the possibility of a centralized purchase of certain expensive drugs for the provision of medical [...]

Golikova proposed to centrally purchase medicines for hospitalsЕлена Матвеева2021-10-29T17:06:13+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

Information letter dated 15.10.2021 No. 02I-1362/21 On the results of state quality control of the medicinal product

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

The Federal Service for Surveillance in Healthcare informs about the receipt of the information on the detection within the framework of inspections for federal state control (supervision) in the field of drug circulation FGBU "Information and Methodological Center for Expertise, Accounting and Analysis of the Circulation of Medical Products" of Roszdravnadzor (Khabarovsk branch) drug "Amiodarone, [...]

Information letter dated 15.10.2021 No. 02I-1362/21 On the results of state quality control of the medicinal productЕлена Матвеева2021-10-29T17:00:56+03:00