The following form should be completed by the healthcare professional. If you are a patient, his guardian or representative go to the form intended for you.
Fields marked with an asterisk (*) are required.
Patient information
Adverse reaction occurred in patients treated:
Outcome:
Is there a causal link between adverse reaction and drug used:
Product(s) Information Suspected of Causing Adverse Reactions:
Is the adverse reaction abated after discontinuation of the medicinal product?
Is the adverse reaction reappeared after reintroduction of the drug?
Concomitant medicinal products and additional information:
Other medicinal products used and the start and end dates of administration, indications, doses that were used at the same time as the drug (s) suspected of causing adverse reactions (exclude those used to treat adverse reaction)
Other past or concurrent illness / other medically relevant information (e.g. diagnostics, allergies, genetics or family conditions).
Details of the person reporting:
*Qualifications of reporting person:
All the information and personal data you share with us in your adverse drug reaction notification will be protected and kept confidential in line with COMPANY POLICY and local regulations.
The information you provide will be used for the purpose of drug safety surveillance [and to enable us to deal with your notification appropriately] and it may be shared with health authorities if such obligation results from provisions of law.
You have a right of access to and to rectify your personal data which we hold about you.
Providing data marked with * is obligatory, under Art. 36e of the Act of 6 September 2001. - Pharmaceutical Law. Providing other data is voluntary.
Data controller: Accord Healthcare Ltd. (Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4AF, United Kingdom).
Contact data of reporting person:
Providing the following information is not mandatory but it could facilitate the analysis of adverse reaction reported by you, if the contact to obtain additional information is required.
Contact details of the person reporting:
