4202 results
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Referral: Loratadine Sandoz 10
loratadine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/05/2009, EC decision date: 06/08/2009, Last updated: 12/12/2009Loratadine Sandoz 10 … of the medicine Loratadine Sandoz 10. The Agency's Committee … the benefits of Loratadine Sandoz 10 do not outweigh its risks … -
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Referral: Bovilis BVD
Article 33
Status: European Commission final decision, opinion/position date: 17/04/2007, EC decision date: 29/06/2007, Last updated: 07/12/2011Bovilis BVD … decision Overview Bovilis BVD/Bovilis BVD-MD is an inactivated virus vaccine … inactivated antigen of cytopathic BVD virus strain C-86. The product … -
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … medicinal product Calcium Sandoz Effervescent tablets, 500/1000 … benefit/risk ratio of Calcium Sandoz Effervescent tablets, 500/1000 … -
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Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … of the medicine Budesonide Sandoz. The Agency's Committee for … the benefits of Budesonide Sandoz outweigh its risks, and the … -
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Referral: Methylphenidate Sandoz
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Sandoz … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the … -
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Press release: Astellas Pharma Europe B.V. withdraws its application for an extension of the indication for Qutenza (capsaicin)
CHMP, Last updated: 20/03/2012Astellas Pharma Europe B.V. withdraws its application … by Astellas Pharma Europe B.V. of its decision to withdraw … 2011, Astellas Pharma Europe B.V. submitted an application … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (doxorubicin hydrochloride)
CHMP, Last updated: 21/07/2011Pharmaceutical Industries Europe B.V. withdraws its marketing … Pharmaceutical Industries Europe B.V. of its decision to withdraw … Pharmaceutical Industries Europe B.V. withdraws its marketing … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan)
Last updated: 17/02/2011Pharmaceutical Industries Europe B.V. withdraws its marketing … Pharmaceutical Industries B.V. of its decision to withdraw … Pharmaceutical Industries Europe B.V. withdraws its marketing … -
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Press release: Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel hydrobromide)
Last updated: 23/04/2009Teva Pharma B.V. withdraws its marketing … Teva Pharma B.V. withdraws its marketing … PRESS RELEASE Teva Pharma B.V. withdraws its marketing … -
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Press release: European Medicines Agency notified of recall of swine fever vaccine (Porcilis Pesti) by Intervet International BV
Last updated: 05/05/2008by Intervet International BV … by Intervet International BV … by Intervet International BV The European Medicines … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Repaglinide SUN (repaglinide)
Last updated: 25/03/2010Pharmaceutical Industries Europe B.V. withdraws its marketing … Pharmaceutical Industries B.V. of its decision to withdraw … Pharmaceutical Industries Europe B.V. withdraws its marketing … -
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Press release: Targanta Netherlands B.V. withdraws its marketing authorisation application for Ramvocid (oritavancin)
Last updated: 24/08/2009Targanta Netherlands B.V. withdraws its marketing … notified by Targanta Netherlands B.V. of its decision to withdraw … -
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Opinion/decision on a Paediatric investigation plan (PIP): clopidogrel hydrogen sulfate, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001257-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/04/2012, Last updated: 24/05/2012, Compliance check: Xthromboembolism Oral use Sandoz BV The Netherlands Phone: +31 … application submitted by Sandoz BV on 2 December 2011 under … decision is addressed to Sandoz BV, Veluwezoom 22, 1327 AH, Almere … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002852-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2020, Last updated: 22/09/2021, Compliance check: XContact for public enquiries Sandoz B.V. Email: caroline.kleinjan@sandoz.com … application submitted by Sandoz B.V. on 13 July 2020 under Article … decision is addressed to Sandoz B.V., Veluwezoom 22, 1327 AH … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 September 2008
CHMP, Last updated: 25/09/2008concerned are: Budesonide Sandoz 32/64 μg nasal spray (budesonide … spray (budesonide), from Sandoz Pharmaceutical GmbH, indicated … should be included. Loratadine Sandoz 10, 10 mg tablets (loratadine … -
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News: European Medicines Agency finalises review of antidepressants in children and adolescents
CHMP, Last updated: 25/04/2005substances: atomoxetine, citalopram, duloxetine, escitalopram … substances: atomoxetine, citalopram, duloxetine, escitalopram … SSRIs/SNRIs: atomoxetine, citalopram, duloxetine, escitalopram … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Farmaceuticos, Lda Mometasone Furoate Sandoz mometasone furoate Sandoz B.V … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Pregabalin Sandoz … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015
CHMP, Last updated: 24/07/2015Pemetrexed Sandoz … -
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Veterinary medicine European public assessment report (EPAR): Bovela
modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93,
Date of authorisation: 22/12/2014, Revision: 4, Authorised, Last updated: 27/11/2019live bovine viral diarrhoea (BVD) virus BVDV-1 and BVDV-2). It is available as a lyophilisate … to protect cattle against BVD viral infection. In non-pregnant … -
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National expert: Susanne Breedijk-van den Ende, Medicines Evaluation Board (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.33 KB | PDF
Coordinator Regulatory Affairs Sandoz B.V. (Netherlands) November … -
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National expert: Marco van Teijlingen, Medicines Evaluation Board (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.52 KB | PDF
Regulatory Affairs Associate Sandoz B.V. (Netherlands) February … -
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Veterinary medicine European public assessment report (EPAR): Netvax
Clostridium-perfringens-type-A alpha toxoid, Chicken
Date of authorisation: 16/04/2009, Revision: 2, Withdrawn, Last updated: 11/06/2014details >Intervet International BV2 16/04/2009 Intervet International … 16/04/2009 Intervet International B.V. Wim de Körverstraat 35 … to Intervet International B.V. on 16 April 2009. Information … -
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National expert: Tania Schink, European Medicines Agency (updated)
- Declaration of interests - 82.21 KB | PDF
- Curriculum Vitae - 25.56 KB | PDF
Panpharma SA), Pharmachemie BV (Teva), Pharmacosmos A/S … Pharmacosmos A/S, Rafarm SA, Sandoz SAS, Sanofi Aventis Groupe … -
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Veterinary medicine European public assessment report (EPAR): Gonazon
azagly-nafarelin, Dogs; Salmonidae (Salmonid fish)
Date of authorisation: 20/07/2003, Revision: 7, Withdrawn, Last updated: 15/08/2012details >Intervet International BV7 20/07/2003 Intervet International … 20/07/2003 Intervet International B.V. Wim de Körverstraat 35 … was Intervet International BV. The European Commission …