Argentina - Drug Information Association

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Regulatory version: None Language: German Germany - Mustertext: Tamoxifen - Oral Forms - Package Leaflet - 13-Jan-2011 Official example of the Package Leaflet (Gebrauchsinformation) for Tamoxifen - tablets/film coated tablets - prepared by BfArM. This is the 10th revision. Document date: 13-Jan-2011 Type of text: Mustertext Regulatory version: None Language: German Germany - Mustertext: Xylometazoline - Nasal Forms - Package Leaflet - 06-Jan- 2011 Official example of the Package Leaflet (Gebrauchsinformation) for Xylometazoline - nasal forms -prepared by BfArM. This is the 13th revision. Document date: 06-Jan-2011 Type of text: Mustertext Regulatory version: None Language: German Germany - Mustertext: Xylometazoline - Nasal Forms - Technical Information Leaflet (SPC) - 06-Jan-2011 Official example of the Technical Information Leaflet (Fachinformation) for Xylometazoline - nasal forms - prepared by BfArM. This is the 13rd revision. Document date: 06-Jan-2011 Type of text: Mustertext Regulatory version: None Language: German Germany - PEI: Reports of Narcolepsy in Temporal Association with the Use of PANDEMRIX - 01-Feb-2011 Further to the statement of 23-Aug-2010 (112593) about reports of narcolepsy following vaccination with PANDEMRIX in Sweden and Finland, the Paul Ehrlich Institute wishes to provide updated information regarding cases reported in Germany from Oct-2010 to 31-Nov-2010. 8 cases of narcolepsy in temporal association with the use of PANDEMRIX have been reported in Germany over this period. 6 occurred in female patients, 2 in male patients. 7 occurred in children aged 9-15 and one in a 26 year old woman. The Paul Ehrlich Institute will take part to a multinational study supported by the European Center for Disease Prevention and Control (ECDC) in order to investigate the potential association of PANDEMRIX vaccination with narcolepsy. The Netherlands, Spain, Italy, Denmark, Sweden, Finland, Norway, Great Britain, Germany, France and Island will take part to this study. Document date: 01-Feb-2011 Type of text: Other texts Regulatory version: None Language: German Greece Greece - Circular-Decision of EOF 66198/30-09-2010: Determination of the Summary of Product Characteristics & Patient Information Leaflet for Pharmaceutical Products containing as the Active Ingredient ACETYLCYSTEINE in Oral Forms, 30-Sep-2010 The Summary of Product Characteristics and Patient Information Leaflet for pharmaceutical products containing as the active ingredient ACETYLCYSTEINE in oral forms are determined in this circular. Comment: Following this Circular, Circular of EOF 12636/04-04-02: Determination of the Summary of Product Characteristics and Patient Information Leaflet for Pharmaceutical Products for Oral Use Containing Acetylcysteine as Active Ingredient, 04-Apr-2002 (35594) is no longer valid. Document date: 30-Sep-2010 Type of text: Circular, EOF Circular Regulatory version: Final Language: Greek
Japan Japan - PFSB/ELD Notification No. 0127/1: ICH Guideline Topic Q4B Annex 10(R1) Step 4: Evaluation & Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter, 27- Jan-2011 (Japanese version) This annex is the result of the Q4B process for Polyacrylamide Gel Electrophoresis General Chapter. The official pharmacopoeial texts, the Section in Ph.Eur. 2.2.31. Electrophoresis entitled Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS-PAGE), JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as interchangeable in the ICH regions. Comment: *** The English version is available as in issued by the ICH committee (114890) Document date: 27-Jan-2011 Type of text: Guideline, Notification, PFSB/ICH Guideline Regulatory version: Final Language: Japanese Japan - PFSB/ELD Notification No. 0127/2: ICH Guideline Topic Q4B Annex 9(R1) Step 4: Evaluation & Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter, 27-Jan-2011 (Japanese version) This annex is the result of the Q4B process for Tablet Friability General Chapter. The analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.7. Friability of Uncoated Tablets, JP General Information 26. Tablet Friability Test, and USP Tablet Friability, can be used as interchangeable in the ICH regions. Comment: *** The English version is available as in issued by the ICH committee (114886) Document date: 27-Jan-2011 Type of text: Guideline, Notification, PFSB/ICH Guideline Regulatory version: Final Language: Japanese Japan - PFSB/ELD Notification No. 0127/3: ICH Guideline Topic Q4B Annex 11 Step 4: Evaluation & Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter, 27-Jan-2011 (Japanese version) This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.2.47. Capillary Electrophoresis, JP General Information 4. Capillary Electrophoresis, and USP General Information Chapter Biotechnology-derived Articles – Capillary Electrophoresis,1 can be used as interchangeable in the ICH regions. Comment: *** The English version is available as in issued by the ICH committee (110486) Document date: 27-Jan-2011 Type of text: Guideline, Notification, PFSB/ICH Guideline Regulatory version: Final Language: Japanese Japan - PFSB/ELD Notification No. 0127/4: ICH Guideline Topic Q4B Annex 12 Step 4: Evaluation & Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter, 27-Jan-2011 (Japanese version) This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.38. Particle-size Distribution Estimation by Analytical Sieving, JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method, and USP General Chapter Particle Size Distribution Estimation by Analytical Sieving, can be used as interchangeable in the ICH regions. Comment: *** The English version is available as in issued by the ICH committee (110491) Document date: 27-Jan-2011 Type of text: Guideline, Notification, PFSB/ICH Guideline Regulatory version: Final Language: Japanese Japan - PFSB/ELD Notice: Amendments for Handling of Notification of Protocols
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Argentina - Drug Information Association

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