On 31 August 2016 the autonomous Community of Madrid, Spain,reported two cases of infection with Crimean–Congo haemorrhagicfever(CCHF) virus.The primary case isa 62-year-old man withpotential exposure to CCHF virus in the countryside inthe province of Ávila (Spain).

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• Crimean–Congo haemorrhagic fever in Spain

for approval of a clinical trial on a veterinary medicinal product BASG/AGES Medizinmarktaufsicht Traisengasse 5, A-1200 Wien APPLICATION FORM - Request for approval of a clinical trial on a veterinary medicinal [...] state/EEA/third country? ☐ Yes ☐ No If yes, country/countries and, in case of a positive outcome the date of approval/in case of a negative outcome date of rejection: Is this study submitted simultaneously [...] Degree or qualification Address Phone No. E-mail APPLICATION FORM - Request for approval of a clinical trial on a veterinary medicinal product F_LCM_VIE_HEVE_Z136_01 Gültig ab: 31.03.2023 1/8

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• Clinical trials

fulfilled in order to have a collection facility or tissue bank registered or approved? 2. Is it possible for doctors of a hospital to act as a "mobile collection team" of a collection facility? 3. Does [...] Para. 2 and § 22 Para. 2 GSG, as this is a new process. 8. If a patient from a tissue collection centre brings blood findings (HIV, HCV, HBV, syphilis) from a laboratory prior to cell/tissue collection [...] arranges an appointment for an on-site inspection with the tissue establishment. A written notice containing a rough agenda and a list of documents and information to be submitted follows this. The on-site

Assessment of the Advisory Board on Classification regarding active+med Wund- und Sonnenbrandsalbe (German only)

Referenced at:

• Decisions of the AGBR

Zero Day MR procedures. The CMDh agreed on a new procedural advice on Zero Day MR procedures. The Zero Day procedure is a mutual recognition procedure with a shortened timetable that can be initiated in [...] February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those Member States that require a full documentation in standard renewal procedures under their [...] will be published in a separate document (in addition to the CMDh Minutes). It has also been added how the start of the non-cumulative period of one year of data exclusivity for a new therapeutic indication

Situation Austria: currently only parallel marketed Italian Herceptin and Alimta are affected (as of 18.4.2014). The drug Herceptin is approved throughout Europe for the treatment of early breast cancer, metastatic breast cancer and metastatic…

Update from the European Medicines Agency on stolen vials of Herceptin and other affected products

Two related clusters involving autochthonous transmission of chikungunya virus have been detected in the cities of Anzio and Rome, two areas located 60 km apart in the Lazio region of Italy. Transmission of this type, in areas where Aedes albopictusmosquitoes are established and at a time when environmental conditions are suitable for increased mosquito abundance and activity, is not unexpected.

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• Clusters of autochthonous chikungunya cases in Italy

Alter in Jahren Anzahl Personen unbekannt 1.464 über 75 1.766 65-75 1.865 45-64 13.312 18-44 23.645 16-17 215 12-15 180 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten [...] wurden 177 Todesfälle in zeitlicher Nähe zu einer Impfung gegen COVID-19 gemeldet (132 BioNTech/Pfizer, 16 Moderna, 26 AstraZeneca und 3 Janssen). Bei 4 Patient*innen konnte aufgrund des Obduktionsberichts [...] Bei 217 Patient*innen wurden die Nebenwirkungen als lebensbedrohend gemeldet (135 BioNTech/Pfizer, 16 Moderna, 62 AstraZeneca und 4 Janssen), bei insgesamt 107 Personen konnte der Gesundheitszustand w

Referenced at:

• Reports COVID-19 Vaccination

Nebenwirkungen Alter in Jahren Anzahl Personen unbekannt 406 über 75 384 65-75 201 45-64 5.933 18-44 11.117 16-17 22 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen [...] 73 3.446 Muskelschmerzen 760 69 3.051 Übelkeit 431 55 1.350 Schüttelfrost 487 36 940 Erbrechen 109 16 372 Schmerzen in einer Extremität 362 29 296 Bisher wurden in zeitlicher Nähe zu einer Impfung gegen [...] konnte aufgrund des Obduktionsberichts ein Zusammenhang mit der Impfung ausgeschlossen werden. Bei 16 Personen fiel die Impfung in die Inkubationszeit einer COVID-19-Erkrankung im Rahmen derer die Pat

Referenced at:

• Reports COVID-19 Vaccination