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Pharmacovigilance
Announcements

Announcements / Pharmacovigilance

Title	Date	Download
Announcement on the Registration and Authorisation of Medicinal Products - Prevention of Drug-associated Risks, Stage II - Antipsychotics: Adverse Reactions in Neonates Following Administration During the last trimester 30 November 2011 (available in German only) Text of the graduated plan procedure ("Stufenplan")	2011.11.30	download (file size: 16 KB)
Announcement on the Registration and Authorisation of Medicinal Products - Prevention of drug-associated risks, Stage II - 1. SSRI and TCA: Risk of bone fractures 2. SSRI, venlafaxine, and mirtazapine: Risk of primary pulmonary hypertension of the newborn (PPHN) 3. Fluoxetine: Risk of malformations 6 December 2010 (available in German only) to the graduated plan procedure ("Stufenplanverfahren" - available in German only)	2010.12.06	download (file size: 178 KB)
Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM (available in German only) Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM	2010.01.19	download (file size: 62 KB)
Report on adverse drug reactions (available in German only) Report on adverse drug reactions	2010.01.19	download (file size: 214 KB)
6th Announcement relating to the Notification of Undesirable Effects and Abuse of Medicinal Products pursuant to Section 63b sub-sections 1 to 9 AMG 19 January 2010 (available in German only) Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM (available in German only) (file size: 62 KB) Report on adverse drug reactions (available in German only) (file size: 214 KB)	2010.01.19	download (file size: 281 KB)
Announcement on the Registration and Authorisation of Medicinal Products ACE Inhibitors, Angiotensin II Antagonists, and Hydrochlorothiazide as well as Combination Products thereof 30 March 2009(available in German only) text of the graduated plan procedure	2009.03.30	download (file size: 68 KB)
Announcement regarding Medicinal Products Containing Lenalidomide or Thalidomide 08 December 2008 (available in German only)	2008.12.08	download (file size: 740 KB)
Announcement on the Registration and Authorisation of Medicinal Products Antiepileptic Drugs and Suicidal Behaviour 04 September 2008(available in German only) text of the graduated plan procedure	2008.09.04	download (file size: 25 KB)
Announcement regarding the Registration or Authorisation of Medicinal Products: Medicinal Products Containing Carbamazepine, Stevens-Johnson syndrome 04 September 2008 (available in German only)	2008.09.04	download (file size: 33 KB)
Announcement on the Registration, Authorisation, and Post-marketing Authorisation of Medicinal Products, Prevention of Drug-associated Risks: Medicinal Products Containing Paracetamol 14 May 2008 (available in German only)	2008.05.14	download (file size: 15 KB)
5th Announcement relating to the Notification of Undesirable Effects and Abuse of Medicinal Products 05 December 2007 Information and Explanations for the Electronic Transmission of ADR Reports to the BfArM (file size: 40 KB)	2007.12.05	download (file size: 530 KB)
Announcement regarding the Submission of Periodic Safety Update Reports on Medicinal Products in accordance with Section 63b sub-section 5 AMG 14 September 2005 (available in German only)	2005.09.14	download (file size: 74 KB)
Announcement regarding Safety Requirements to Minimise the Risk of Transmission of Animal Transmissible Spongiforme Encephalopathies 16 August 2005 (available in German only)	2005.08.16	download (file size: 860 KB)
Amendment to the Announcement on the Authorisation and Registration of Medicinal Products for Use in Humans 13 July 2004 (available in German only)	2004.07.13	download (file size: 722 KB)
Announcement regarding Medicinal Products Containing Thalidomide 22 December 2003 (available in German only)	2003.12.22	download (file size: 14 KB)
Announcement regarding the authorisation and registration of medicinal products for human use and the safety of marketable medicinal products for human use – Prevention of drug-associated risks, stage II – (medicinal products for human use derived from human blood or tissues) 14 January 1999 (available in German only)	1999.01.14	download (file size: 20 KB)

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