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Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate), Baupharma, 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, certificate pharmaceutical product, 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, module 2, module 3, module 4, module 5preparation, 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, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 16 Feb

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

In order to maintain the safety of the patients, Agencies around the world are continuously updating their requirements. As a result of the adverse effects that a drug may have in the user. In this case, Japan published a new requirement in the clinically significant adverse reactions section. The active substance included are Hydroxyzine hydrochloride and Hydozyzine pamoate. PMDA asks for a revision of the package insert of the product following their indications (see below).

Due to reported cases of acute generalized exanthematous pustulosis in patients treated with hydroxyzine hydrochloride or hydroxyzine pamoate. Including Japan and overseas. For example, United States package insert had a revision. Consequently, an investigation result based on the opinions of expert advisors and the available evidence, the MHLW/PMDA concluded that revision of the package insert was necessary.

In the Clinically Significant Adverse Reactions subsection of the Adverse Reactions section, PMDA asks to include the following text: “Acute generalized exanthematous pustulosis: Acute generalized exanthematous pustulosis may occur. Patients should be carefully monitored. If any abnormalities are observed, administration of this drug should be discontinued and appropriate measures should be adopted.”

Likewise, if you want more information about the topic, you can see the Summary of investigation results and Revision of Precautions.

Baupharma – Pharmacovigilance

Baupharma is a service provider for pharmaceuticals. We are focused on Regulatory Affairs, Pharmacovigilance and Business Development. Our regions of expertise are EU, CIS and MENA. Our aim is to build Pharma, ensure that new products reach the market meeting legislation and agencies’ requirements on pre and post marketing basis. But, specially, our deepest focus is to work close to you and give all support needed. Since we have been working many years on the sector and we understand the importance of knowing you have a partner on whom you can always rely.

If you want more information about this or other subject, get in contact with us at info@baupharma.com

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

Baupharma, 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, certificate pharmaceutical product, 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, module 2, module 3, module 4, module 5preparation, 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, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 15 Feb

New EPARs by EMA. Help your registration!

New EPARs by EMA. Help your registration!

Another week and EMA has released new EPARs for several products. Since you may be thinking about registering a product with their active substance, you may want to take a look.

  • Filgrastim Hexal: a solution for injection or infusion (drip into a vein) in a prefilled syringe. It contains the active substance filgrastim (30 or 48 million units).
  • Hexacima: a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
  • Thyrogen: a powder that is made up into a solution for injection. It contains the active substance thyrotropin alfa.
  • Daklinza is an antiviral medicine used in combination with other medicines to treat chronic (long-term) hepatitis C (an infectious disease of the liver, caused by the hepatitis C virus) in adults. It contains the active substance daclatasvir.
  • Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children. Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance caspofungin.
  • Ameluz is used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition. The medicine contains the active substance 5-aminolaevulinic acid.
  • Rotarix is a vaccine that contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
  • Optaflu is a vaccine that contains ‘surface antigens’ from three different strains (types) of influenza (flu) virus: A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)–like strain; and B/Phuket/3073/2013-like strain.

 

Since this is a selection of the EPARs. For more information, get in contact with us at info@baupharma.com or check EMA’s website.

 

  • Zytiga is a medicine used to treat cancer of the prostate. It contains the active substance abiraterone acetate.
  • Pandemic influenza vaccine H5N1 MedImmune is a vaccine developed to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic. Pandemic influenza vaccine H5N1 MedImmune contains live, attenuated (weakened) influenza A virus A/Vietnam/1203/2004 (H5N1) strain.
  • Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses. It is used in babies and toddlers aged from six weeks.
  • Ravicti is a medicine used long-term to manage urea-cycle disorders in adults and children from the age of two months, when the diseases cannot be managed by changes in their diet alone. Ravicti contains the active substance glycerol phenylbutyrate.
  • Simponi is an anti-inflammatory medicine. Simponi contains the active substance golimumab.
  • Caprelsa is a cancer medicine that is used in adults and children above 5 years of age to treat medullary thyroid cancer. Caprelsa contains the active substance vandetanib.
  • Enbrel is an anti-inflammatory medicine. Enbrel contains the active substance etanercept.
  • Eliquis is used to prevent venous thromboembolism (blood clots in the veins) in adults. Eliquis is a medicine that contains the active substance apixaban.
  • Ivabradine JensonR contains the active substance ivabradine.
  • Evotaz is an antiviral medicine used in combination with other medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Evotaz contains the active substances atazanavir and cobicistat.

 

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 labels. For instance, 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? As a result of the use of part of the original text,  you will be able to update the documentation in the target languages easily. Consequently, 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.

Baupharma – Regulatory Affairs

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

If you want more information about the topic, get in contact with us at info@baupharma.com

Baupharma, 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, certificate pharmaceutical product, 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, module 2, module 3, module 4, module 5preparation, 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, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 14 Feb

Update multi-language labelling in EU

Update multi-language labelling EU

Looks like January was a productive month for CMDh. On their last meeting they have agreed to publish a set of links with special guidance on update multi-language labelling EU developed by some Member States. The update of multi-language labelling in EU will be available under “Product Information” on their website section.

As an illustration, if you have products in Finland, Sweden or Belgium, this is a great piece of news. Regarding those countries, multi language packaging is mandatory. Especially, when you are preparing your SmPC, PIL and Labels. You have to focus not only in content and current QRD but also in the local guidelines and recommendations. With this in mind, it is especially tricky on those countries where labelling is in different languages as you have to check different sources. Finally, most of the information of EU regarding this topic will be centralized.

Baupharma is a service provider for pharmaceutical companies, covering Regulatory AffairsPharmacovigilance and Business Development. Our regions of expertise are EUCIS and MENA.

If you want further information, feel free to contact us at info@baupharma.com

 

Second Edition of the International Day of Women and Girls in Science - Baupharma. Baupharma, 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, module 2, module 3, module 4, module 5preparation, 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, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA 13 Feb

Second Edition of the International Day of Women and Girls in Science

Second Edition of the International Day of Women and Girls in Science

Last Saturday, 11th of February, it was the Second Edition of the International Day of Women and Girls in Science. Indeed, science and gender equality are both vital for the achievement of the internationally agreed development goals. Over the past 15 years, the global community has made a lot of effort in inspiring and engaging women and girls in science.

Unfortunately, women and girls are still excluded from participating fully in science.

Probably, you are more than aware in your daily life, but, in order to give you some figures, the probability for students of graduating with a Bachelor’s degree, Master’s degree and Doctor’s degree in science-related field are (respectably):

  • Female students
    • 18%
    • 8%
    • 2%
  • Male students
    • 37%
    • 18%
    • 6%.

(Study made in 14 countries)

In order to achieve full and equal access to and participation in science for women and girls, and further achieve gender equality and the empowerment of women and girls, the United Nations General Assembly declared 11 February as the International Day of Women and Girls in Science.

Here in Baupharma, we want to celebrate, remember and encourage all women and girls that worked and work in Science. Also, we want to stress the importance and support your success. Thank you for all your achievements, you are building a better version of the world. As a result, this is not only Science, this is a civil and social work too. That all women, and most of the men, are pleased to welcome.

Furthermore, as we work in Science field, we like to take this opportunity to specially thank all our colleagues, partners and friends in the sector. It has been and is a pleasure to see your accomplishments and work with you. We hope many more are coming.

Following the quote of Linda B. Buck in this occasion, Nobel Prize in Physiology or Medicine 2004:

“As a woman in science, I sincerely hope that my receiving a Nobel Prize will senda a message to young women everywhere that the doors are open to them and they should follow their dreams”.

You can find more information at the International Day of Women and Girls in Science website.

Baupharma – We build pharma.

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

9 Feb

Update of the Product Information Leaflet of Combined Hormonal Contraceptives (CHCs) containing ethinylestradiol

If combined hormonal contraceptives are part of your portfolio, pay attention to the new announcement of the CMDh.

The CMDh has agreed a common text to be included in the product information of combined hormonal contraceptives (CHCs) containing ethinylestradiol regarding the interaction concerning concomitant use with medicinal products containing ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir with or without ribavirin, following the inclusion of the same interaction in the product information of ombitasvir/paritaprevir/ritonavir (Viekirax).

The agreed wording will be published on the CMDh website under “Product Information, CMDh recommendations”. Concerned MAHs are requested to implement the agreed wording via the appropriate regulatory procedure.

If you have any question or would like to receive more information, you can get in contact with us at info@baupharma.com or register in our newsletter.

8 Feb

Mandatory update of class risk effect of corticosteroids in Product Information of EU

After the CMDh meeting last month and following the recommendations of PRAC, the products containing the following active substances will have to perform an update on their PIL:

  • budesonide
  • misoprostol (gynaecological indication – labour induction)
  • moxifloxacin (systemic use)
  • nadifloxacin
  • nefopam
  • nicardipine
  • sulprostone
  • treprostinil

PRAC considered that “Blurred Vision” and “Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome and implement this PRAC recommendation via the appropriate regulatory procedures. Further information regarding the above mentioned will be published on the EMA website.

8 Feb

Mandatory update of class risk effect of corticosteroids in Product Information of EU

After the CMDh meeting last month and following the recommendations of PRAC, the products containing the following active substances will have to perform an update on their PIL:

  • budesonide
  • misoprostol (gynaecological indication – labour induction)
  • moxifloxacin (systemic use)
  • nadifloxacin
  • nefopam
  • nicardipine
  • sulprostone
  • treprostinil

PRAC considered that “Blurred Vision” and “Central Serous Chorioretinopathy” is a class risk effect of corticosteroids and should also be included in the product information of the fixed combinations of budesonide as well as other corticosteroids, for all routes of administration. The MAHs of affected products should take due note of the outcome and implement this PRAC recommendation via the appropriate regulatory procedures. Further information regarding the above mentioned will be published on the EMA website.