Pharmacovigilance
Information on reporting adverse reaction
Slavia Pharm S.R.L., as a Marketing Authorization Holder (MAH), collects and evaluates any safety information related to suspected adverse reactions associated with the use of medicinal products manufactured or authorized for marketing by our company.We kindly ask you to report any suspected adverse reaction or special situation you have observed in connection with a medicinal product manufactured by our company by contacting us at email: farmacovigilenta@slaviapharm.ro or the following phone numbers:
- Landline: +4 021 304 63 91
- Cell phone (available 24/7): +4 0731 035 500
In case you (as a patient) or one of your patients (as a doctor or pharmacist) suspect an adverse reaction to one of our medicines, please fill in the adverse reaction reporting form below.
An adverse reaction is defined as „a noxious and undesirable response to a drug”. In this context „response” means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility.
Adverse reactions may also occur in situations such as overdose, misuse, abuse, or medication errors.
In the event of any adverse reaction associated with the use of a medicinal product for human use and if you need medical advice, please consult your doctor, pharmacist or other qualified healthcare professional. Only healthcare professionals can provide appropriate guidance regarding the necessary therapeutic management.
Adverse reaction reporting helps to gather additional information on the safety of medicines and plays an essential role in protecting your health as well as the health of other patients.
Suspected adverse reactions associated with Slavia Pharm medicines can be reported both to the e-mail address dedicated to pharmacovigilance activity mentioned above or directly to the Romanian National Agency for Drugs and Medical Devices (ANMDMR), using one of the following methods:
- Online reporting
- By accessing the platform: https://adr.anm.ro/
- Via the website www.anm.ro, section: Medicines for Human Use → Pharmacovigilance → Report an adverse reaction → Online reporting
- „Patient File” reporting of adverse drug reactions.
The factsheet can be downloaded at: Patient Information Sheet
The document should be printed, completed with the most accurate information available, and sent to ANMDMR by post, fax, or email using the following contact details:
Romanian National Agency for Medicines and Medical Devices (ANMDMR)
Str. Mr. Ștefan Sănătescu nr. 48, Sector 1, 011478, Bucharest, Romania
Fax: +40 21 316 34 97
E-mail: adr@anm.ro
B-dul Theodor Pallady, nr. 44C 032266, Sector 3, Bucharest, Romania
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