SUSPECT ADVERSE REACTION REPORT
|
|
|
- Birgit Vogt
- vor 6 Jahren
- Abrufe
Transkript
1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR Female Ekzem am rechten Ohr ( ): Eczema Einblutung im linken Auge ( ): Einblutung im rechten Auge am rechten Rand ( ): Eye haemorrhage Einblutungen am rechten inneren Augapfel auf, sowie am linken Auge, Blutung am linken Auge war am verschwunden ( ): neue Einblung am rechten äußeren Auge ( ): neue Einblutungen am linken Auge sowohl innen als auch außen ( ): starke Einblutung im rechten Auge, Gefühl, der Augapfel hätte nicht genug Platz. [ MedDRA 19.0 LLT ( ): Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Bei mir wurde Ende letzten Jahres Polymyalgia Rheumatica diagnostiziert. Ergänzend zum Cortison, ausgehend von einer Tagesdosis von 10 mg auf momentan 5 mg, nehme ich bei einem 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) azathioprin 25 mg 1A-Pharma 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 25 Mg milligram(s),1 Day 17. INDICATION(S) FOR USE Polymyalgia rheumatica 18. THERAPY DATES (from/to) 19. THERAPY DURATION DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) cortison (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 ( ): Polymyalgia rheumatica from DEC-2015 (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 25-JUL-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Gewicht zwischen 62 und 60kg täglich 125 mg Azathioprin (25 mg 1A Pharma und 100 mg Hexal) genau nach Anweisung ein. Neben einem Ekzem am rechten Ohr, seit , das eventuell damit zusammanhängt, platzen mir immer weider in einem oder beiden Augen gleichzeitig Äderchen, so dass das Auge rot ist. Es traten mindestens die folgenden Einblutungen auf: Einblutung im linken Auge vorhanden bis mind Einblutung im rechten Auge am rechten Rand, am traten zusätzliche Einblutungen am rechten inneren Augapfel auf, sowie am linken Auge. Die Einblutung am linken Auge war am verschwunden. Hinsichtlich der Einblutungen am rechten Auge war die linke innere (an der Nasenseite befindliche) noch stark vorhanden, die rechte, äußere, war fast weg. Am trat am rechten äußeren Auge eine neue Einblutung auf, erst am waren alle Einblutungen verschwunden. Am neue Einblutung am linken Auge sowohl innen als auch außen. Am starke Einblutung im rechten Auge. Plötzlich hatte ich das Gefühl, als ob mein Augapfel in der Augenhöhle nicht genug Platz hätte. Die Einblutung war am 8.7. immer noch vorhanden, wenn auch nur noch leicht. Weder ein Augenarzt, noch mein Rheumatologe fanden eine Ursache hierfür. Die Blutgerinnungswerte, die man zunächst damit in Zusammenhang brachte, sind in Ordnung. Results of tests and procedures relevant to the investigation of the patient: Untersuchung Augenarzt: ohne Befund Untersuchung Rheumatologe: ohne Befund Blutgerinnungswerte: ohne Befund Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Ekzem am rechten Ohr [MedDRA 19.0 PT ( ): Eczema 26-MAY-2016 ( ): Eczema Einblutung im linken Auge 7 Day 11-JAN JAN-2016 Einblutung im rechten Auge am rechten Rand 03-MAY-2016 Einblutungen am rechten inneren Augapfel auf, sowie am linken Auge, Blutung am linken Auge war am verschwunden 7 Day recovered/resolved 11-MAY MAY-2016 neue Einblung am rechten äußeren Auge 19 Day recovered/resolved neue Einblutungen am linken Auge sowohl innen als auch außen 18-MAY MAY JUN-2016
3 Report Page: 3 of 6 starke Einblutung im rechten Auge, Gefühl, der Augapfel hätte nicht genug Platz. 18-JUN-2016 * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) azathioprin 25 mg 1A-Pharma A: B: C: 25Mg milligram(s) D: E: 1Day Polymyalgia rheumatica Identification of the country where the drug was obtained Name of holder/applicant 1A-Pharma Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name azathioprine 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s)
4 Report Page: 4 of 6 azathioprin 100mg Hexal A: B: C: 100Mg milligram(s) D: E: 1Day Identification of the country where the drug was obtained Name of holder/applicant Hexal Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name azathioprine 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) cortison A: B: C: 5Mg milligram(s) D: E: 1Day Polymyalgia rheumatica Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug
5 Report Page: 5 of 6 Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name cortisone acetate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.0 ( ): Polymyalgia rheumatica DEC ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents Yes No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Yes No Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 74 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn
6 Report Page: 6 of 6 Postcode Country Fax Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Weight (kg) 62 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16226405 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17056924 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR erhöhter
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200992 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Unterleibskrämpfe
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17203133 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 32 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16272270 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR Female DA MO
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16287026 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 75 (Year) Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16118335 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy starke Schwindelanfälle (10013582):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17407687 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 27 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17148488 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR Male
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17278782 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 29 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17069443 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 48 (Year) DA
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16333916 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET (10019211): Headache ] grippeähnliche
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16394153 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 19.1
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16372160 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR Extremer Schwindel
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17073011 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Lippentrockenheit (10024552):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17156899 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy QTc-Zeit Verlängerung [ MedDRA
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17190360 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 52 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390214 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR [ MedDRA 19.1 LLT
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390200 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 19.1
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183946 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 20.0
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16394121 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR [ MedDRA 19.1 LLT
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17127357 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 55 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16113389 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR flacher
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17129488 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 22 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16206297 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 24 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17129436 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR Abnahme
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17289702 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 51 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16176231 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE [ MedDRA 19.0 LLT (10042464):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17243762 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17053675 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 61 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17313976 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 48 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17137576 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 49 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17229921 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 54 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17348420 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 12 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16414972 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE im Bereich der oberen
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17192241 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR Frühdyskinesie
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200292 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 62 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17143195 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 18 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17139859 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 46 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17379880 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 36 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16388837 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 56 DA MO YR ()
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17411865 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 76 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17174538 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10044055): Toothache ] (10049870):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16404695 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 28 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy schwere Hyperkaliämie (10020646): Hyperkalaemia
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 73 DA MO YR (Year) Male 17 10 2014
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16131686 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR Enzephalopathie
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17243881 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR (10043890): Tiredness
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16113385 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Kreislaufschwäche
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16370282 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 49 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17152847 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 17 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17165207 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17227985 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR toxiche Agranulozytoe
POST MARKET CLINICAL FOLLOW UP
POST MARKET CLINICAL FOLLOW UP (MEDDEV 2.12-2 May 2004) Dr. med. Christian Schübel 2007/47/EG Änderungen Klin. Bewertung Historie: CETF Report (2000) Qualität der klinischen Daten zu schlecht Zu wenige
Intrauterine instillation of diluted seminal plasma in in vitro fertilization a double-blind, placebo controlled, randomized study
PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Intrauterine instillation of diluted seminal plasma in in vitro fertilization a double-blind, placebo controlled, randomized
LOC Pharma. Anlage. Lieferantenfragebogen Supplier Questionnaire. 9. Is the warehouse temperature controlled or air-conditioned?
Please complete this questionnaire and return to: z.h. Leiter Qualitätsmanagement info@loc-pharma.de Name and position of person completing the questionnaire Signature Date 1. Name of Company 2. Address
FIVNAT-CH. Annual report 2002
FIVNAT-CH Schweizerische Gesellschaft für Reproduktionsmedizin Annual report 2002 Date of analysis 15.01.2004 Source: FileMaker Pro files FIVNAT_CYC.FP5 and FIVNAT_PAT.FP5 SUMMARY TABLE SUMMARY RESULTS
APPLICATION. DeutscherAkademischerAustauschDienst GERMAN ACADEMIC EXCHANGE SERVICE 871 UN Plaza, New York, NY 10017
APPLICATION DeutscherAkademischerAustauschDienst GERMAN ACADEMIC EXCHANGE SERVICE 871 UN Plaza, New York, NY 10017 Telephone: (212) 758-3223 Fax: (212) 755-5780 E-Mail: daadny@daad.org Website: http://www.daad.org
Tools in a Clinical Information System Supporting Clinical Trials at a Swiss University Hospital (Clin Trials, published online 12 August 2014)
ehealth Summit 2014, Bern Tools in a Clinical Information System Supporting Clinical Trials at a Swiss University Hospital (Clin Trials, published online 12 August 2014) Dr. med. Michael Weisskopf Forschungszentrum
ANLAGE 4. Final wording for SPC and package leaflet (PL)
ANLAGE 4 NON-SELECTIVE NSAIDS FOR SYSTEMIC ADMINISTRATION OVER THE COUNTER (OTC) PRODUCTS Final wording for SPC and package leaflet (PL) As agreed by the PhVWP in December 2006, revised in January 2007
Application Form (Bewerbungsformular) Unpaid Work Experience. Incoming (Aufnahme)
Application Form (Bewerbungsformular) Unpaid Work Experience Incoming (Aufnahme) PERSONAL INFORMATION Family Name Date of Birth Country Sex (!) Male Female City PERIOD OF TI M E First Name Address SKYPE
Telefon, your contact Telephone
Deutsche Rentenversicherung Bund 10704 BERLIN, GERMANY ZRBG 932 Datum und Zeichen Ihrer Nachricht Date and reference of your correspondence Telefax Fax number Telefon, your contact Telephone 0049 30 865-0049
Wissenswertes zu den jährlichen Sicherheitsberichten bzw. DSURs
Wissenswertes zu den jährlichen Sicherheitsberichten bzw. DSURs Dr. Corina Spreitzer Institut Überwachung, Abteilung Klinische Prüfungen AGES-Gespräch Wien, 29.10.2015 www.basg.gv.at Österreichische Agentur
Exercise (Part XI) Anastasia Mochalova, Lehrstuhl für ABWL und Wirtschaftsinformatik, Kath. Universität Eichstätt-Ingolstadt 1
Exercise (Part XI) Notes: The exercise is based on Microsoft Dynamics CRM Online. For all screenshots: Copyright Microsoft Corporation. The sign ## is you personal number to be used in all exercises. All
DVMD Tagung Hannover 2011
DVMD Tagung Hannover 2011 Vorstellung der Bachelorarbeit mit dem Thema Schwerwiegende Verstöße gegen GCP und das Studienprotokoll in klinischen Studien - Eine vergleichende Analyse der Regularien der EU-Mitgliedsstaaten
Dun & Bradstreet Compact Report
Dun & Bradstreet Compact Report Identification & Summary (C) 20XX D&B COPYRIGHT 20XX DUN & BRADSTREET INC. - PROVIDED UNDER CONTRACT FOR THE EXCLUSIVE USE OF SUBSCRIBER 86XXXXXX1. ATTN: Example LTD Identification
Which data and when?
PRO-data for market access in Germany where and when? Frank-Ulrich Fricke PRO-data for market access in Germany where and when? AMNOG the German assessment Which data and when? Requirements to be met Seite
ANLAGE 3. Final wording for SPC and package leaflet (PL)
ANLAGE 3 NON-SELECTIVE NSAIDS FOR SYSTEMIC ADMINISTRATION PRESCRIPTION ONLY MEDICINES (POM) Final wording for SPC and package leaflet (PL) As agreed by the PhVWP in December 2006, revised in January 2007
Newest Generation of the BS2 Corrosion/Warning and Measurement System
Newest Generation of the BS2 Corrosion/Warning and Measurement System BS2 System Description: BS2 CorroDec 2G is a cable and energyless system module range for detecting corrosion, humidity and prevailing
APPLICATION. DeutscherAkademischerAustauschDienst GERMAN ACADEMIC EXCHANGE SERVICE 871 UN Plaza, New York, NY 10017
APPLICATION DeutscherAkademischerAustauschDienst GERMAN ACADEMIC EXCHANGE SERVICE 871 UN Plaza, New York, NY 10017 Telephone: (212) 758-3223 Fax: (212) 755-5780 E-mail: daadny@daad.org Website: http://www.daad.org
Abteilung Internationales CampusCenter
Abteilung Internationales CampusCenter Instructions for the STiNE Online Enrollment Application for Exchange Students 1. Please go to www.uni-hamburg.de/online-bewerbung and click on Bewerberaccount anlegen
Intercultural educations by Means of PArtners working with ECvet Transfer LdV (TOI): DE/10/LLP-LdV/TOI/147303
Intercultural educations by Means of PArtners working with ECvet Transfer LdV (TOI): DE/10/LLP-LdV/TOI/147303 Product 5 IMPAECT Assessment Sheet for Students IMPAECT ASSESSMENT OF LEARNING OUTCOMES NAME
Level 1 German, 2014
90886 908860 1SUPERVISOR S Level 1 German, 2014 90886 Demonstrate understanding of a variety of German texts on areas of most immediate relevance 9.30 am Wednesday 26 November 2014 Credits: Five Achievement
WERKSKALIBRIERSCHEIN FACTORY CALIBRATION CERTIFICATE
WERKSKALIBRIERSCHEIN FACTORY CALIBRATION CERTIFICATE Gegenstand Object Hersteller Manufacturer Typ Type Seriennummer Serial Number Software Version Software Version Gerätekalibrierdatum Device calibration
Ein universelles Bayes-Design für einarmige Phase II-Studien mit binärem zeitlich erfasstem Endpunkt
Ein universelles Bayes-Design für einarmige Phase II-Studien mit binärem zeitlich erfasstem Endpunkt Joachim Gerß joachim.gerss@ukmuenster.de Institute of Biostatistics and Clinical Research Overview 1.
eurex rundschreiben 094/10
eurex rundschreiben 094/10 Datum: Frankfurt, 21. Mai 2010 Empfänger: Alle Handelsteilnehmer der Eurex Deutschland und Eurex Zürich sowie Vendoren Autorisiert von: Jürg Spillmann Weitere Informationen zur
Application Form (Bewerbungsformular) Unpaid Work Experience. Incoming (Aufnahme)
Application Form (Bewerbungsformular) Unpaid Work Experience Incoming (Aufnahme) PERSONAL INFORMATION Family Name Date of Birth Country Sex Male Female City SKYPE Name PERIOD OF TIME First Name Address
Medizinische Klinik II Medizinische Klinik IV
CAMPUS GROSSHADERN CAMPUS INNENSTADT LOREM IPSUM SETUR ALARME Medizinische Klinik II Medizinische Klinik IV Effect of Mipomersen on LDL-Cholesterol levels in Patients with Severe LDL-Hypercholesterolemia
How does the Institute for quality and efficiency in health care work?
Health Care for all Creating Effective and Dynamic Structures How does the Institute for quality and efficiency in health care work? Peter T. Sawicki; Institute for Quality and Efficiency in Health Care.
Statement of Licensing Status of Pharmaceutical Products 1)
No. of Statement: Exporting (certifying) country: Germany Importing (requesting) country: Statement of Licensing Status of Pharmaceutical Products 1) This statement indicates only whether or not the following
Level 2 German, 2015
91126 911260 2SUPERVISOR S Level 2 German, 2015 91126 Demonstrate understanding of a variety of written and / or visual German text(s) on familiar matters 2.00 p.m. Friday 4 December 2015 Credits: Five
Registration of residence at Citizens Office (Bürgerbüro)
Registration of residence at Citizens Office (Bürgerbüro) Opening times in the Citizens Office (Bürgerbüro): Monday to Friday 08.30 am 12.30 pm Thursday 14.00 pm 17.00 pm or by appointment via the Citizens
Level 1 German, 2016
90886 908860 1SUPERVISOR S Level 1 German, 2016 90886 Demonstrate understanding of a variety of German texts on areas of most immediate relevance 2.00 p.m. Wednesday 23 November 2016 Credits: Five Achievement
Exercise (Part VIII) Anastasia Mochalova, Lehrstuhl für ABWL und Wirtschaftsinformatik, Kath. Universität Eichstätt-Ingolstadt 1
Exercise (Part VIII) Notes: The exercise is based on Microsoft Dynamics CRM Online. For all screenshots: Copyright Microsoft Corporation. The sign ## is you personal number to be used in all exercises.
Franke & Bornberg award AachenMünchener private annuity insurance schemes top grades
Franke & Bornberg award private annuity insurance schemes top grades Press Release, December 22, 2009 WUNSCHPOLICE STRATEGIE No. 1 gets best possible grade FFF ( Excellent ) WUNSCHPOLICE conventional annuity
A. Wutte, J. Plank, M. Bodenlenz, C. Magnes, W. Regittnig, F. Sinner, B. Rønn, M. Zdravkovic, T. R. Pieber
Proportional ose Response Relationship and Lower Within Patient Variability of Insulin etemir and NPH Insulin in Subjects With Type 1 iabetes Mellitus A. Wutte, J. Plank, M. Bodenlenz, C. Magnes, W. Regittnig,
Prüfbericht Nr. / Test Report No: F (Edition 1)
Emission date: 22.01.2015 Page: 1 of 5 Prüfbericht Nr. / Test Report No: F4-44254-48401-01 (Edition 1) Auftraggeber Applicant Geräteart Type of equipment Typenbezeichnung Type designation Seriennummer
Firma, Adresse: Company, Adress. Namen der verantwortlichen für die Qualitätssicherung: Names of resposible person for quality assurance:
Firma, Adresse: Company, Adress Namen der verantwortlichen für die Qualitätssicherung: Names of resposible person for quality assurance: 1. Qualitätsnachweis Quality control Werden Prüfunterlagen systematisch
Deutsch. DGAP Stimmrechtsmitteilung: Epigenomics AG Veröffentlichung gemäß 26 Abs. 1 WpHG mit dem Ziel der europaweiten Verbreitung
Deutsch DGAP Stimmrechtsmitteilung: Epigenomics AG Veröffentlichung gemäß 26 Abs. 1 WpHG mit dem Ziel der europaweiten Verbreitung 24.07.2017 / 21:36 Veröffentlichung einer Stimmrechtsmitteilung übermittelt
Invitation to the International Anglers Meeting 2015 Silo Canal/Brandenburg 15.10. - 17.10. 2015
Event-UG (haftungsbeschränkt) DSAV-event UG (haftungsbeschränkt) Am kleinen Wald 3, 52385 Nideggen Invitation to the International Anglers Meeting 2015 Silo Canal/Brandenburg 15.10. - 17.10. 2015 Ladies
Guidance Notes for the eservice 'Marketing Authorisation & Lifecycle Management of Medicines' Contents
Guidance Notes for the eservice 'Marketing Authorisation & Lifecycle Management of Medicines' Contents Login... 2 No active procedure at the moment... 3 'Active' procedure... 4 New communication (procedure
Supplier Status Report (SSR)
Supplier Status Report (SSR) Introduction for BOS suppliers BOS GmbH & Co. KG International Headquarters Stuttgart Ernst-Heinkel-Str. 2 D-73760 Ostfildern Management Letter 2 Supplier Status Report sheet
A cross-sectional study to improve a targeted, individualized sports therapy program for childhood cancer patients
PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title A cross-sectional study to improve a targeted, individualized sports therapy program for childhood cancer patients Trial
Antrag auf Gewährung eines Abschlussstipendiums der Graduiertenakademie Application for a Completion Grant from the Graduate Academy
Antrag auf Gewährung eines Abschlussstipendiums der Graduiertenakademie Application for a Completion Grant from the Graduate Academy A: PERSÖNLICHE ANGABEN PERSONAL INFORMATION Herr / Mr. Frau / Ms. Name
Country fact sheet. Noise in Europe overview of policy-related data. Germany
Country fact sheet Noise in Europe 2015 overview of policy-related data Germany April 2016 The Environmental Noise Directive (END) requires EU Member States to assess exposure to noise from key transport