Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Pharma Nord ApS, Tinglykke 4-6, DK-6500 Vojens, Denmark
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC, as amended.
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC, as amended.
Adequate tests on reproductive toxicity and tests on genotoxicity and carcinogenicity have not been performed.
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