- This topic is empty.
- You must be logged in to reply to this topic.
Home › Forums › Pharmacovigilance Forum › SPC review for Bibliographic products
Hello,
I am currently preparing an annual safety review for one of my company’s generic products and as part of this would normally do a review of our SPC against the reference product’s SPC. However, the licence for the product in question was submitted as a bibliographic licence so there is no reference product. I have looked for another product on the market for the comparison, but ours is the only injectable version of this active. Could anyone advise what I should do in this situation please? Would it be enough to compare to an oral version of the product of the same strength? I’m aware the safety profile would be slightly different given the difference in administration routes, but the general side effect profile should be similar. Any thoughts?
Thank you!
Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.
Dear Member,
Thank you for your enquiry regarding SPC review for Bibliographic products.
One could compare an oral formulation with injectable form with some rationale – if toxicity is Cmax driven, then it is likely that an injectable form will have higher Cmax, if it is AUC driven, then most of the toxicity for an injectable could be anticipated for oral, but there would be no local injection reactions or infusion reactions.
Kind regards
PIPA.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie | Duration | Description |
---|---|---|
cookielawinfo-checkbox-analytics | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". |
cookielawinfo-checkbox-functional | 11 months | The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". |
cookielawinfo-checkbox-necessary | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". |
cookielawinfo-checkbox-others | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. |
cookielawinfo-checkbox-performance | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". |
viewed_cookie_policy | 11 months | The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. |
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.