Current information on the investigation of cases of narcolepsy after vaccination with Pandemrix
Thursday, August 26, 2010
In total, there are 12 cases of narcolepsy reported to the MPA from healthcare professionals in Sweden with a suspected relationship to vaccination with Pandemrix. In addition to the cases reported in Sweden and Finland there are a few further cases reported in France, Germany and Norway. An investigation is ongoing, but any relationship between the vaccination and the reported symptoms can not be concluded.
The MPA investigates reports of narcolepsy in patients vaccinated with Pandemrix
Wednesday, August 18, 2010
The MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination. The Agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions. The MPA is in contact with other EU member states to get information if there are any reports in other countries.
The MPA is reorganising
Monday, June 28, 2010
The MPA is currently undergoing a reorganisation and many employees are going to change rooms within our premises. We kindly ask for your indulgence for any interference that might occur.
Final summary of ADR reports in Sweden with Pandemrix
Wednesday, June 02, 2010
As of April 16, 2010 about 6.1 million adult doses of Pandemrix have been administered according to preliminary data from the county councils to the Swedish Institute for Infectious Disease Control (SMI). The Medical Products Agency (MPA) has received a total of 4380 adverse events reports (ADR) from Health Care Professionals and from consumers during the pandemic period. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine is satisfactory.
New routines in Sweden for handling recalls of medicinal products from the 15th of March, 2010
Wednesday, March 17, 2010
On the 15th of March, 2010, new routines for handling recalls will be introduced in Sweden for all products regulated by the legislation (Medicinal Products Act (SFS 1992:859) of the medicinal products: conventional medicinal products, herbal medicinal products, traditional herbal medicinal products, natural remedies, certain medicinal products for external use, homeopathic medicinal products and standardised extemporaneous preparations (stock manufacturing).
New information on the website due to new variation regulation
Friday, February 26, 2010
The webpage on variations has been extensively updated with new information regarding the handling of variations in accordance with the new variation regulation.
MPA to lead European collaboration on drug effectiveness
Monday, February 01, 2010
During 2010, Medical Products Agency will be in head of a collaborative effort to improve the dissemination of knowledge about medicinal effects in clinical everyday life in Europe. The MPA will support networks within the EU as a successful working in the field of "drug effectiveness".
New procedures for product information on the MPA
Monday, January 18, 2010
The stamp, which the MPA puts on approved product information, is now replaced with a header that includes date of the revision of the text. MPA also change the file format on published SPCs and patient information leaflets from PDF to DOC.
Summary of Adverse Drug Reaction reports in Sweden with Pandemrix received through January 8
Monday, January 18, 2010
About 5.3 million individuals in Sweden, corresponding to 60% of the Swedish population, have been vaccinated with Pandemrix as of January 8. In total, the Medical Products Agency has received about 3700 adverse event reports from Health Care Professionals and from consumers. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine in use is satisfactory.
The Medical Products Agency simplifies the MAH electronic reporting of ADRs
Tuesday, January 05, 2010
The Medical Products Agency (MPA) has decided - in agreement with the European Medicines Agency (EMA) - to simplify the electronic handling of adverse reaction reporting.
Guideline in English – labelling and package leaflets for medicinal products
Thursday, December 17, 2009
A guideline to the Medical Products Agency´s regulation (2005:11) on labelling and package leaflets for medicinal products is now published on the website.
Proposals for stricter environmental requirements for pharmaceutical industry
Thursday, December 17, 2009
Medical Products Agency (MPA) has been commissioned by the Swedish Government to identify opportunities for strengthening the environmental requirements pertaining to the manufacturing of medicinal products with greatest emphasis on EU and international efforts rather than national work. The report suggests, among other, requirement for an environmental certification of the production facilities to be introduced to the legislation on good manufacturing practice (GMP).
New variation Regulation, (EC) No 1234/2008
Wednesday, December 16, 2009
The new variation regulation (EC) No 1234/2008 applies from 1 January 2010 for medicinal products approved via the mutual recognition procedure (MRP), decentralized procedure (DCP) and the Centralised procedure. The new variation regulation replaces the former regulations: (EC) No 1084/2003 (MRP/DCP) and (EC) No 1085/2003 (centralised marketing authorisations).
Summary of Adverse Drug Reaction reports in Sweden with Pandemrix received through December 4
Monday, December 14, 2009
Almost 4 million individuals in Sweden have been vaccinated as of December 4. In total, the Medical Products Agency has received close to 3000 adverse event reports from Health Care Professionals and from consumers. The reporting pattern is generally consistent with what has been seen from previous clinical trials, with the exception of allergic and neurological reactions. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine in use is satisfactory.
Pilot project of joint scientific advice meetings is extended
Wednesday, December 02, 2009
The pilot project of joint scientific advice meetings arranged by the TLV and the MPA is extended to June 30th 2010. The last date for a meeting with the TLV and the MPA is therefore June 30th 2010. Applications for a meeting in May or June should be submitted to the MPA at least 2 months before.
Summary of Adverse Drug Reaction reports in Sweden with Pandemrix received through November 20
Thursday, November 26, 2009
Almost 3.4 million adult doses of Pandemrix have been delivered to Sweden as of November 17. According to data from the Swedish Institute for Infectious Disease Control (SMI), by November 15 approximately 1.9 million individuals in Sweden have been vaccinated. In total, the Medical Products Agency has received close to 1000 adverse event reports from Health Care Professionals and about 1300 reports from consumers. The reporting pattern is generally consistent with what has been seen from previous clinical trials, with the exception of allergic reactions.
New variation Regulation, (EC) No 1234/2008
Friday, November 20, 2009
The new variation regulation (EC) No 1234/2008 applies from 1 January 2010 for medicinal products approved via the mutual recognition procedure (MRP), decentralized procedure (DCP) and the Centralised procedure. The new variation regulation replaces the former regulations: (EC) No 1084/2003 (MRP/DCP) and (EC) No 1085/2003 (centralised marketing authorisations).
EU-Presidency Conference on Sustainable Development and Pharmaceutical
Monday, November 16, 2009
On 10-11 November the Medical Products Agency hosted a European Conference on “Sustainable Development and Pharmaceuticals”. EU environmental and health authorities, the Commission, Parliament, the European Medicines Agency EMEA, industry and academia attended the meeting which took place in Uppsala.
Summary of ADR reports in Sweden with Pandemrix (received up to November 10)
Thursday, November 12, 2009
As of today, about 2.1 million doses of Pandemrix have been distributed in Sweden. In total, almost six hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and close to 900 reports from Consumers. The ADR reporting pattern is generally consistent with the expected pattern seen previously in the clinical trials. In this compilation of ADRs reported in Sweden with Pandemrix, allergic reactions, neurological reactions and reactions in children are specifically addressed.
Summary of adverse drug reaction reports in Sweden with Pandemrix
Thursday, October 29, 2009
As of today, about 1.4 million doses of Pandemrix have been distributed in Sweden. In total, about two hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and between 400-500 reports from consumers. The ADR reporting pattern does not deviate from what has been seen in the clinical trials. However, there is particular reason to follow reports of allergic reactions.