Marketing Authorization

2018 ◽  
pp. 79-98
Author(s):  
Rebecca Sheets
Keyword(s):  
Marketing Authorization

scholarly journals Use of Hexyon/Hexacima/Hexaxim in preterm infants in Europe

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
F Boisnard ◽  
F Caracci ◽  
N Badzhinerov ◽  
P Dhont ◽  
B Isnardy ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Safety Data ◽  
Standard Of Care ◽  
European Countries ◽  
Marketing Authorization ◽  
Haemophilus Influenzae Type ◽  
Black Triangle ◽  
Susceptibility To Infection ◽  
Authorization Holder ◽  
Post Marketing

Abstract Background Worldwide 13 million babies born prematurely every year have increased susceptibility to infection and require adequate immunization. Hexavalent vaccines against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b are standard of care in pediatric vaccination and are particularly important for preterm infants. Hexyon® is registered in Europe since April 2013. Methods Considering birth data from official national databases and only countries with periods of exclusive use of Hexyon from 2013-19, we estimated the total number of preterm infants (<37weeks GA) vaccinated with Hexyon. Results Since registration, Hexyon has been used in 23 European countries and exclusively used in the following: Austria, Feb-2017 to present; Belgium, Jul-2014 (Flanders)/Sep-2015 (Overall) to present; Bulgaria, Nov-2014 to Dec-2016; Croatia, Jan-2016 to present; Denmark, Feb-2016 to Apr-2017; Italy, Apr-2016 to present, exclusivity based on Regions; Macedonia, Oct-2015 to present; Norway, Feb-2017 to present; Romania, Apr-2015 to Dec-2017. The estimated total number of preterm infants during these periods of exclusive use is 183 000. Assuming 90% vaccination coverage, ∼164 700 preterm infants received at least 1 dose of this vaccine. From the analysis of the post-marketing safety data available to date, no new risk has been identified in preterm infants. Conclusions Hexyon has become a standard for hexavalent immunization in infants, regardless of the gestational age at birth. More than 90 million doses have been administered worldwide, including the estimated 164 000 preterm infants in the 9 European countries considered here. The EU Marketing Authorization granted in 2013 with no contraindication for use in preterm infants, was renewed in 2018 and the black triangle was removed confirming that the safety of Hexyon is well established. The marketing authorization holder continues to support evidence generation for use in preterm infants. Key messages Hexyon/Hexacima/Hexaxim has become a standard for hexavalent immunization in infants including for preterm infants (<37weeks GA); around 164 000 preterm infants in 9 European countries received it. The safety of Hexyon/Hexacima/Hexaxim is well established, no new risk has been identified in preterm infants from the analysis of the post-marketing safety data available to date.

scholarly journals A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines

2021 ◽  
Author(s):  
Marjolein Garsen ◽  
Maaike Steenhof ◽  
Alex Zwiers
Keyword(s):  
Anticancer Drugs ◽  
Marketing Authorization ◽  
European Medicines Agency ◽  
Company Size ◽  
Scientific Advice ◽  
The European Union ◽  
Small Companies ◽  
Procedure Time ◽  
Total Procedure Time ◽  
Total Procedure

Abstract Background Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of patients. In this study, we analyzed the procedural timelines of marketing authorization applications for anticancer drugs in the EU, with a specific focus to special regulatory programs, scientific advice and company size. Methods Anticancer drugs that received an opinion from the EMA between January 2010 and December 2019 were included in the study. Public assessment reports were used to obtain publicly available information of the drugs. Results We identified 96 applications for new anticancer drugs. 34 applications were granted access to at least one expedited program offered by the EMA. Total procedure time was reduced from average 370 to 200–215 days when accelerated assessment was granted. Granting of a conditional marketing authorization or an orphan designation, as well as having scientific advice, only mildly affected total procedure time. Average total procedure time of small companies was much longer compared with medium-sized and large companies (483 versus 356 days), which was caused by an increased clock stop time. Conclusion Total procedure time for anticancer is mainly affected by the granting of accelerated assessment, which reduced the total procedure time, and company size, where total procedure time is much longer for small companies. Small companies are advised to have, and especially adhere to scientific advice to reduce procedure time and increase the chance of success.

Efektivitas Penegakan Hukum Terhadap Pelaku Usaha Yang Memproduksi dan Memperdagangkan Kosmetik Ilegal Berbahaya: Studi Polres Pelabuhan

2020 ◽  
Vol 1 (1) ◽  
pp. 59-81
Author(s):  
La Ode Muhammad Jefri Hamzah ◽  
Abdul Agis ◽  
Hamza Baharuddin
Keyword(s):  
Law Enforcement ◽  
Consumer Protection ◽  
Legal Status ◽  
Criminal Liability ◽  
Descriptive Study ◽  
Empirical Approach ◽  
Marketing Authorization ◽  
Legal Knowledge ◽  
Legal Structure ◽  
Laws And Regulations

Tujuan penelitian ini adalah untuk: (1) Menganalisis efektivitas pertanggungjawaban pidana terhadap pelaku usaha yang memproduksi dan memperdagangkan kosmetik ilegal berbahaya ditinjau dari Undang-Undang No. 8 Tahun 1999 tentang Perlindungan Konsumen; dan (2) Menganalisis faktor-faktor yang mempengaruhi efektivitas pertanggungjawaban pidana terhadap pelaku usaha yang memproduksi dan memperdagangkan kosmetik ilegal berbahaya ditinjau dari Undang-Undang Nomor 8 Tahun 1999 tentang Perlindungan Konsumen. Penelitian ini adalah penelitian deskriptif dengan pendekatan yuridis-empiris. Hasil penelitian menunjukkan bahwa: Penegakan hukum terhadap pelaku usaha yang memproduksi dan memperdagangkan kosmetik ilegal yang berbahaya di Wilayah Polres Pelabuhan Makassar terlaksana kurang efektif. Meskipun demikian, proses penegakan hukum yang dilakukan tersebut sudah mengacu pada ketentuan perundang-undangan yang berlaku, seperti tersangka Sdr. ARFANDY alias ARFANDY BIN MUSTAFA yang terbukti melakukan tindak pidana mengedarkan sediaan farmasi/ kosmetika yang tidak memiliki izin edar, sehingga tersangka dijerat dengan Pasal 197 Jo pasal 106 ayat (1) UU R.I. No. 36 Tahun 2009 tentang Kesehatan, dan juga dijerat dengan Pasal 62 Ayat (1) Jo Pasal 8 ayat (1) UU R.I No. 8 Tahun 1999 tentang Perlindungan Konsumen. Faktor substansi hukum, struktur hukum, budaha hukum, sarana dan prasarana, dan pengetahuan hukum kurang berpengaruh terhadap penegakan hukum terhadap pelaku usaha kosmetik illegal yang berbahaya di Polres Pelabuhan Makassar. The purpose of this study is to: (1) Analyze the effectiveness of criminal liability against business actors who produce and trade dangerous illegal cosmetics in terms of Law No. 8 of 1999 concerning Consumer Protection; and (2) Analyzing the factors that influence the effectiveness of criminal liability against business actors producing and trading dangerous illegal cosmetics in terms of Law No. 8 of 1999 concerning Consumer Protection. This research is a descriptive study with a juridical-empirical approach. The results of the study show that: Law enforcement against businesses that produce and trade dangerous cosmetics that are dangerous in the Makassar Port Police Area is ineffective. Nevertheless, the law enforcement process carried out has referred to the applicable laws and regulations, such as the suspect Br. ARFANDY alias ARFANDY BIN MUSTAFA who was proven to have committed a crime of distributing pharmaceutical / cosmetic preparations that did not have a marketing authorization, so that the suspect was charged with Article 197 Jo article 106 paragraph (1) of Law R.I. No. 36 of 2009 concerning Health, and also snared with Article 62 Paragraph (1) Jo Article 8 Paragraph (1) of Law R.I No. 8 of 1999 concerning Consumer Protection. The factors of legal substance, legal structure, legal status, facilities and infrastructure, and legal knowledge have less influence on law enforcement against dangerous cosmetics business operators in Makassar Port Police

scholarly journals Anti-PD1 Drugs: Are The Reimbursed Indications Of The Marketing Authorization Respected?

2018 ◽  
Vol 21 ◽  
pp. S44
Author(s):  
C Therasse ◽  
P Paubel ◽  
A Cordonnier ◽  
I Fusier
Keyword(s):  
Marketing Authorization

Subcutaneous auto-administration of trastuzumab following therapeutic education: A case report

2018 ◽  
Vol 25 (6) ◽  
pp. 1523-1525 ◽  
Author(s):  
Marine Deppenweiler ◽  
Marc Debled ◽  
Jean-Luc Robquin ◽  
Barbara Lortal-Canguilhem
Keyword(s):  
Monoclonal Antibody ◽  
Case Report ◽  
Education Program ◽  
Marketing Authorization ◽  
Therapeutic Education ◽  
Breast Cancers ◽  
Self Administration ◽  
Patient’S Experience ◽  
Epidermal Growth

Trastuzumab is a monoclonal antibody used to treat human epidermal growth receptor 2 positive (HER2+) breast cancers either by itself or in combination with other chemotherapy medication. Marketing authorization was granted for a subcutaneous form of the antibody in 2014. In this case report, we discuss our experience with a patient who took part in a therapeutic education program on self-administration of trastuzumab. We demonstrate that these types of self-administered injections are not only possible but also are toxicity-free. Based on the tolerance data and our patient’s experience, we propose that the current regulations be relaxed regarding the availability of trastuzumab subcutaneous form in order to develop a cheaper “city scheme,” i.e. self-administered injections.

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