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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

On amendments to the general characteristics (SPC) and instructions for medical use (PIL) of medicinal products containing indapamide as an active ingredient

Елена Матвеева2021-10-28T14:12:22+03:00

Information on erectile dysfunction, hypomagnesemia, hypochloremia, hypokalemia, hyponatremia should be included in the instructions (short medicinal product characteristics, PIL) of products containing indapamide. data source and details

On amendments to the general characteristics (SPC) and instructions for medical use (PIL) of medicinal products containing indapamide as an active ingredientЕлена Матвеева2021-10-28T14:12:22+03:00

To authorization applicants and manufacturers of medicinal products containing dipyridamole as an active ingredient

Елена Матвеева2021-10-28T13:51:20+03:00

In connection with the letter of the Federal State Budgetary Institution "Scientific Center for the Expertise of Medicinal Products" of the Ministry of Health of Russia dated 09.09.2021 No. 22592 (input No. 2-180129 dated 09.10.2021), the Department of State Regulation of Medicines Circulation informs Of the Russian Federation of medicinal products for medical use containing [...]

To authorization applicants and manufacturers of medicinal products containing dipyridamole as an active ingredientЕлена Матвеева2021-10-28T13:51:20+03:00

On new data on the safety of the drug Ixel (INN — Milnacipran)

Елена Матвеева2021-10-27T13:43:39+03:00

Added information on the possibility of developing serotonin syndrome when combined with Buprenorphine (based on the PRAC recommendation). 4.4. Special warnings and precautions for use Interaction with other drugs and other forms of interaction Information has been added on the possibility of postpartum hemorrhage during therapy with selective serotonin reuptake inhibitors (SSRIs) and serotonin and [...]

On new data on the safety of the drug Ixel (INN — Milnacipran)Елена Матвеева2021-10-27T13:43:39+03:00

Information letter dated 07.10.2021 No. 01I-1295/21 About changing email addresses

Елена Матвеева2021-10-25T16:50:33+03:00

The Federal Service for Surveillance in Healthcare, as part of the execution of the state function of organizing and conducting pharmacovigilance, informs about the termination of the functioning of the e-mail domain @roszdravnadzor.ru. Currently, the @roszdravnadzor.gov.ru domain is operating, including email addresses for collecting information on pharmacovigilance such as pharm@ roszdravnadzor.gov.ru (for MA holders and [...]

Information letter dated 07.10.2021 No. 01I-1295/21 About changing email addressesЕлена Матвеева2021-10-25T16:50:33+03:00

Safety variations for Ponatinib

Елена Матвеева2021-10-25T16:42:33+03:00

After reviewing the available evidence and evaluating the evidence provided by the relevant Marketing Authorization Holder (MAH), PRAC agreed that the product information for Ponatinib should be updated to reflect the risk of panniculitis. data source and details

Safety variations for PonatinibЕлена Матвеева2021-10-25T16:42:33+03:00