Finnish Medicines Agency

Helsinki, Finland

Finnish Medicines Agency

Helsinki, Finland
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FIT Biotech Oy ("Company") has received today a EUR 644,868 payment from its HIV collaborator, the European HIV Vaccine Alliance (EHVA).  The payment was received as part of the contracted scheduled payments for manufacturing the Company's investigational DNA-based HIV vaccine for a large multicenter Phase I/2 clinical trial planned to initiate later this year.  EHVA is financed by the Horizon 2020 program of the European Commission. FIT Biotech manufactures the investigational DNA-based HIV vaccine for EHVA in its own GMP production facility in Tampere, Finland, that is approved by the Finnish Medicines Agency (Fimea). This facility has the capacity to produce investigational drugs up to Phase 2 clinical trials, thus ensuring a rapid capability to introduce new DNA-based drug candidates to clinical trials. FIT Biotech Oy is a biotechnology company established in 1995. The company develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines. FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines. FIT Biotech shares are listed on the First North Finland marketplace maintained by Nasdaq Helsinki Oy.


Hameen-Anttila K.,Finnish Medicines Agency | Jyrkka J.,Finnish Medicines Agency | Enlund H.,Finnish Medicines Agency | Nordeng H.,University of Oslo | And 3 more authors.
BMJ Open | Year: 2013

Objectives: The aim was to assess the perceived needs of medicines information and information sources for pregnant women in various countries. Design: Cross-sectional internet-based study. Setting: Multinational. Participants: Pregnant women and women with children less than 25 weeks. Primary and secondary outcome measures: The need for information about medicines was assessed by a question: 'Did you need information about medicines during the course of your pregnancy?' A list of commonly used sources of information was given to explore those that are used. Results: Altogether, 7092 eligible women responded to the survey (5090 pregnant women and 2002 women with a child less than 25 weeks). Of the respondents, 57% (n=4054, range between different countries 46-77%) indicated a need for information about medicines during their pregnancy. On average, respondents used three different information sources. The most commonly used information sources were healthcare professionalsphysicians (73%), pharmacy personnel (46%) and midwifes or nurses (33%)and the internet (60%). There were distinct differences in the information needs and information sources used in different countries. Conclusions: A large proportion of pregnant women have perceived information needs about medicines during pregnancy, and they rely on healthcare professionals. The internet is also a widely used information source. Further studies are needed to evaluate the use of the internet as a medicines information source by pregnant women.


Hameen-Anttila K.,Finnish Medicines Agency | Nordeng H.,University of Oslo | Kokki E.,Finnish Medicines Agency | Jyrkka J.,Finnish Medicines Agency | And 3 more authors.
Journal of Medical Internet Research | Year: 2014

Background: A wide variety of information sources on medicines is available for pregnant women. When using multiple information sources, there is the risk that information will vary or even conflict. Objective: The objective of this multinational study was to analyze the extent to which pregnant women use multiple information sources and the consequences of conflicting information, and to investigate which maternal sociodemographic, lifestyle, and medical factors were associated with these objectives. Methods: An anonymous Internet-based questionnaire was made accessible during a period of 2 months, on 1 to 4 Internet websites used by pregnant women in 5 regions (Eastern Europe, Western Europe, Northern Europe, Americas, Australia). A total of 7092 responses were obtained (n=5090 pregnant women; n=2002 women with a child younger than 25 weeks). Descriptive statistics and logistic regression analysis were used. Results: Of the respondents who stated that they needed information, 16.16% (655/4054) used one information source and 83.69% (3393/4054) used multiple information sources. Of respondents who used more than one information source, 22.62% (759/3355) stated that the information was conflicted. According to multivariate logistic regression analysis, factors significantly associated with experiencing conflict in medicine information included being a mother (OR 1.32, 95% CI 1.11-1.58), having university (OR 1.33, 95% CI 1.09-1.63) or other education (OR 1.49, 95% CI 1.09-2.03), residing in Eastern Europe (OR 1.52, 95% CI 1.22-1.89) or Australia (OR 2.28, 95% CI 1.42-3.67), use of 3 (OR 1.29, 95% CI 1.04-1.60) or>4 information sources (OR 1.82, 95% CI 1.49-2.23), and having ≥2 chronic diseases (OR 1.49, 95% CI 1.18-1.89). Because of conflicting information, 43.61% (331/759) decided not to use medication during pregnancy, 30.30% (230/759) sought a new information source, 32.67% (248/759) chose to rely on one source and ignore the conflicting one, 25.03% (190/759) became anxious, and 2.64% (20/759) did nothing. Factors significantly associated with not using medication as a consequence of conflicting information were being pregnant (OR 1.75, 95% CI 1.28-2.41) or experiencing 3-4 health disorders (OR 1.99, 95% CI 1.10-3.58). Women with no chronic diseases were more likely not to take medicines than women with ≥2 chronic diseases (OR 2.22, 95% CI 1.47-3.45). Factors significantly associated with becoming anxious were>4 information sources (OR 2.67, 95% CI 1.70-4.18) and residing in Eastern Europe (OR 0.57, 95% CI 0.36-0.90). Conclusions: Almost all the pregnant women used multiple information sources when seeking information on taking medicines during pregnancy and one-fifth obtained conflicting information, leading to anxiety and the decision not to use the medication. Regional, educational, and chronic disease characteristics were associated with experiencing conflicting information and influenced the decision not to use medication or increased anxiety. Accurate and uniform teratology information should be made more available to the public.


Kurl S.,University of Eastern Finland | Makikallio T.H.,University of Oulu | Makikallio T.H.,Lapland Central Hospital | Rautaharju P.,Wake forest University | And 3 more authors.
Circulation | Year: 2012

Background-Previous studies indicate that increased QRS duration in ECG is related to the risk of all-cause death. However, the association of QRS duration with the risk of sudden cardiac death (SCD) is not well documented in large population-based studies. Our aim was to examine the relation of QRS duration with SCD in a population-based sample of men. Methods and Results-This prospective study was based on a cohort of 2049 men aged 42 to 60 years at baseline with a 19-year follow-up, during which a total of 156 SCDs occurred. As a continuous variable, each 10-ms increase in QRS duration was associated with a 27% higher risk for SCD (relative risk, 1.27; 95% confidence interval, 1.14-1.40; P<0.001). Subjects with QRS duration of >110 ms (highest quintile) had a 2.50-fold risk for SCD (relative risk, 2.50; 95% confidence interval, 1.38-4.55; P=0.002) compared with those with QRS duration of <96 ms (lowest quintile), after adjustment for established key demographic and clinical risk factors (age, alcohol consumption, previous myocardial infarction, smoking, serum low-and high-density lipoprotein cholesterol, C-reactive protein, type 2 diabetes mellitus, body mass index, systolic blood pressure, and cardiorespiratory fitness). In addition to QRS duration, smoking, previous myocardial infarction, type 2 diabetes mellitus, cardiorespiratory fitness, body mass index, systolic blood pressure, and C-reactive protein were independently associated with the risk of SCD. Conclusions-QRS duration is an independent predictor of the risk of SCD and may have utility in estimating SCD risk in the general population. © 2012 American Heart Association, Inc.


Weise M.,Federal Institute for Drugs and Medical Devices | Kurki P.,Finnish Medicines Agency | Wolff-Holz E.,Paul Ehrlich Institute | Bielsky M.-C.,Medicines and Healthcare Products Regulatory Agency | And 2 more authors.
Blood | Year: 2014

Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called "biosimilars") and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and that have been licensed based on extrapolation of efficacy and safety data from other indications. This article addresses the concerns frequently raised in the medical community about the use of biosimilars in such extrapolated indications and explains the underlying scientific and regulatory decision making including some real-life examples from recently licensed biosimilars. © 2014 by The American Society of Hematology.


Kriikku P.,University of Helsinki | Kriikku P.,Vita Health Care Services Ltd | Rintatalo J.,National Bureau of Investigation Forensic Laboratory | Pihlainen K.,Finnish Medicines Agency | And 2 more authors.
International Journal of Legal Medicine | Year: 2015

In this study, we sought to determine what impact the banning of 3, 4- methylenedioxypyrovalerone (MDPV) had on the incidence of MDPV-positive findings and on user profiles in driving under the influence of drugs (DUID) and postmortem (PM) investigations in Finland. All MDPV-positive cases and a selection of corresponding court cases between 2009 and 2012 were examined. The median serum concentration of MDPV in DUID cases was 0.030 mg/L and in PM blood 0.12 mg/L. The number of MDPV-positive cases decreased both in DUID and PM investigations after the drug was banned. The decrease in the mean monthly numbers of MDPV-positive DUID cases was 51.1%. In court cases, MDPV was rarely mentioned until banned and frequently mentioned thereafter. Of the convicted, 37% were without a fixed abode, 98% had other charges besides that of DUID, and 13% appeared in the study material more than once. In MDPV-positive PM cases, the proportion of suicides was very high (24%). Research on new psychoactive substances is required not only to support banning decisions but more importantly to be able to provide a scientific assessment of the risks of these new substances to the public and potential users. © 2015, Springer-Verlag Berlin Heidelberg.


Hameen-Anttila K.P.,Finnish Medicines Agency | Niskala U.R.,University of Eastern Finland | Siponen S.M.,University of Eastern Finland | Ahonen R.S.,University of Eastern Finland
BMC Complementary and Alternative Medicine | Year: 2011

Background: The use of complementary and alternative medicines (CAM) has been extensively studied globally among adult and paediatric populations. Parents, as a group, had not been studied to assess their knowledge and attitude to CAM and general medicine use. This study is necessary since parents' attitude to medicine use is known to influence their child's attitude to medicine use later in life. We therefore aim to assess the extent and types of CAM use among Finnish parents, and to determine the factors that promote the CAM use. Also, we aim to determine parents' attitude to general medicine use.Methods: Children less than 12 years old, as of spring 2007, were identified from the database of the Finnish Population Register Centre and were selected by random sampling. The parents of these children were identified and a questionnaire was sent to them. Only the parent who regularly takes care of the child's medicine was requested to fill the questionnaire. Cross-tabulations and Chi-square test were used to determine the associations between categorical variables. CAMs were defined as natural products that are not registered as medicines, such as homeopathic preparations, dietary food supplements, and traditional medicinal products.Results: The response rate of the survey was 67% (n = 4032). The use of CAM was 31% in the preceding two days. The most commonly used CAM products were vitamins and minerals, followed by fish oils and fatty acids. Prescription and OTC medicines were used concomitantly with CAM by one-third of the parents. CAM was frequently used by parents over 30 years (33%), female parents (32%), highly educated parents (35%), and parents with high monthly net income (3000-3999 euros, 34%). The users of CAM had more negative attitudes towards medicines than non-users of CAM.Conclusions: Our findings are in accordance with those of previous studies that women over 30 years of age with a high education and income typically use CAMs. Finnish parents seem to use CAMs as complementary rather than alternative to medicines. Health care professionals should take into consideration both the concomitant use as well as the negative attitudes among CAM users in encounters with the parents. © 2011 Hämeen-Anttila et al; licensee BioMed Central Ltd.


Hameen-Anttila K.P.,Finnish Medicines Agency
BMC complementary and alternative medicine | Year: 2011

The use of complementary and alternative medicines (CAM) has been extensively studied globally among adult and paediatric populations. Parents, as a group, had not been studied to assess their knowledge and attitude to CAM and general medicine use. This study is necessary since parents' attitude to medicine use is known to influence their child's attitude to medicine use later in life. We therefore aim to assess the extent and types of CAM use among Finnish parents, and to determine the factors that promote the CAM use. Also, we aim to determine parents' attitude to general medicine use. Children less than 12 years old, as of spring 2007, were identified from the database of the Finnish Population Register Centre and were selected by random sampling. The parents of these children were identified and a questionnaire was sent to them. Only the parent who regularly takes care of the child's medicine was requested to fill the questionnaire. Cross-tabulations and Chi-square test were used to determine the associations between categorical variables. CAMs were defined as natural products that are not registered as medicines, such as homeopathic preparations, dietary food supplements, and traditional medicinal products. The response rate of the survey was 67% (n = 4032). The use of CAM was 31% in the preceding two days. The most commonly used CAM products were vitamins and minerals, followed by fish oils and fatty acids. Prescription and OTC medicines were used concomitantly with CAM by one-third of the parents. CAM was frequently used by parents over 30 years (33%), female parents (32%), highly educated parents (35%), and parents with high monthly net income (3000-3999 euros, 34%). The users of CAM had more negative attitudes towards medicines than non-users of CAM. Our findings are in accordance with those of previous studies that women over 30 years of age with a high education and income typically use CAMs. Finnish parents seem to use CAMs as complementary rather than alternative to medicines. Health care professionals should take into consideration both the concomitant use as well as the negative attitudes among CAM users in encounters with the parents.


Sinnemaki J.,Finnish Medicines Agency
Systematic reviews | Year: 2013

An automated dose dispensing (ADD) service has been implemented in primary healthcare in some European countries. In this service, regularly used medicines are machine-packed into unit-dose bags for each time of administration. The aim of this study is to review the evidence for ADD's influence on the appropriateness of medication use, medication safety, and costs in primary healthcare. A literature search was performed in April 2012 in the most relevant databases (n = 10), including the Medline, Embase, and Cochrane Library. The reference lists of the studies selected were manually searched. A study was included in the review if the study was conducted in primary healthcare or nursing home settings and medicines were dispensed in unit-dose bags. Out of 328 abstracts, seven studies met the inclusion and reporting quality criteria, but none applied a randomized controlled study design. Of the four controlled studies, one was a national register-based study. It showed that the patient group in the ADD scheme more often used three or more psychotropic drugs and anticholinergics than patients using the standard dispensing procedure, while women in the ADD group used less long-acting benzodiazepines and both genders had fewer drug-drug interactions. In another, regional controlled study, the ADD group consisted of patients with higher risk of inappropriate drug use, according to all indicators applied. The third controlled study indicated that ADD user drug treatments were more likely to remain unchanged than in patients using a standard dispensing procedure. A controlled study from Norway showed that ADD reduced discrepancies in the documentation of patient medication records. Costs were not investigated in any of the studies. A very limited number of controlled studies have explored ADD in primary healthcare. Consequently, the evidence for ADD's influence on appropriateness and safety of medication use is limited and lacking in information on costs. The findings of this review suggest that patients using the ADD have more inappropriate drugs in their regimens, and that ADD may improve medication safety in terms of reducing the discrepancies in medication records. Further evidence is needed to draw sound conclusions on ADD's outcomes.


Siponen S.M.,University of Eastern Finland | Ahonen R.S.,University of Eastern Finland | Kettis A.,Uppsala University | Hameen-Anttila K.P.,Finnish Medicines Agency
European Journal of Clinical Pharmacology | Year: 2012

Purpose The aim of this study was to measure patterns of complementary and alternative medicine (CAM) use among Finnish children and to explore whether CAM use among children is mainly complementary or alternative. Methods We carried out a cross-sectional population-based survey in spring 2007. The study population consisted of a representative sample (n06,000) of Finnish children under 12 years of age. A questionnaire was sent to their parents, and 4,032 questionnaires were returned (response rate 67 %). Pearson's chi-square test and logistic regression analysis were conducted to measure factors associated with CAM use. Results The prevalence of CAM use among children was 11 %. Fish oils and fatty acids (6 %) followed by probiotics (4 %) were the most commonly reported CAMs used. Being the first born, using vitamins and having at least one symptom predicted the use of CAMs. Parental use of vitamins and CAMs were also associated with CAM use among children. In the preceding 2 days, 3 % of children in the study had used only CAMs, and 7 % had used a CAM concomitantly with prescribed and/or over-the-counter medicines. Conclusions Our results indicate that the use of CAMs among Finnish children is mainly for improving health and alleviating symptoms, especially in families where at least one parent also uses these modalities. CAMs were mainly used as complementary rather than as an alternative to conventional care. Healthcare professionals should be aware of this complementary use of CAMs and medicines in patients to avoid risks of potential interactions. © Springer-Verlag 2012.

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