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EMA published the updated EPAR for Uptravi (selexipag): SmPC, PIL and Labels in all EU languages

EMA published updated EPAR Uptravi, selexipag: SmPC, PIL, Labelling, Labelling, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EU, CIS, MENA, Registration, Renewal, variation, license, local QPPV, EU QPPV, Safety Officer, in licenses, out license, risk management plan, PSUR, Price and reimbursement, cpp, distributor, local company representatives, sales forces, environmental risk assessment, psmf, nonclinical overview, clinical overview, DSUR, SOP, CAPA, CA/PA, PIL, PL, SMPC, Labelling, literature articles, phv, marketing, marketed, MAH, PSMF, literature research, local literature research, global literature research, safety, ICSR, XEVMPD, IDMP, CP, DCP, NP, centralize procedure, decentralize procedure, national procedure, GCC, submission, regulatory support, gap analysis, ectd, e-ctd, publishing, module 1, preparation, cover letter, application form, electronic application form, artwork, braille, mockup, mock up, mock-up, consultation with target patient groups, readability testing, nonclinical summary, clinical summary, NEES, ctd, pharmaceuticals, pharma, we build pharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development 10 Feb

EMA published the updated EPAR for Uptravi (selexipag): SmPC, PIL and Labels in all EU languages

If you are thinking about registering a product with selexipag as active substance, finally: it’s your lucky day! EMA has published their last update of the EPAR for Uptravi film-coated tablets (selexipag). And contains full SmPC, PIL and labelling. Especially relevant as it is an approved reference document in all EU languages. Consequently, it will save you time, struggle and will minimize your risks and costs of registration.

Why is the EPAR important? How can it save you a lot of time and struggle during your registration?

First of all, when the EPAR is published it usually comes along with SmPC, PIL and lables. You can use these documents as reference for your medical writing. It will save you time but also, EMA  recommends the use of approved  products as reference to ensure consistency. Secondly, once you have to present the Consultation with Target Patient Groups you won’t have to do a full readability testing. If you have other products registered and approved, you can use one of the mockups as a reference and perform a Double Bridging Report. If you don’t know how, get in contact with us, we can help you with it.

Last but not least, SmPC, PIL and labelling is published in all official EU languages. What does it mean? Again, if you have used most of the original text,  you will be able to update the documentation in the target languages easily. Probably you are having the same question again. Yes, we also can help you with that. Our translators with pharmaceutical and medical background are ready to perform any update according to EMA and local requirements. Since all of our translators only translate into their native language, this ensures consistency and coherence.

Uptravi

Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen. Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors.

Uptravi can be used on its own if the patient is not a candidate for these medicines. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other symptoms. By mimicking the action of prostacyclin, Uptravi widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. It relieves the symptoms of PAH and improves the course of the disease.

You can find the last version of the EPAR for Uptravi (selexipag) at EMA website

Baupharma – Regulatory Affairs

Baupharma is a service provider for pharmaceuticals. We are focused in Regulatory Affairs, Pharmacovigilance, Translations, Medical Writing and Business Development. Our regions of expertise are EU, CIS and MENA.

Feel free to contact us at info@baupharma.com