FAIN

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

17-9-2018

Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate / dolutegravir sodium / lamivudine, Revision: 10, Authorised

Europe - EMA - European Medicines Agency

12-9-2018

Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible Particles - Update on the Use of Medical Grade Filters

MedEffect Canada

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

4-9-2018

Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Revision: 4, Authorised

Europe - EMA - European Medicines Agency

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

31-8-2018

Human medicines European public assessment report (EPAR): Colobreathe, colistimethate sodium, Revision: 9, Authorised

Europe - EMA - European Medicines Agency

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

20-8-2018

Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Revision: 28, Authorised

Europe - EMA - European Medicines Agency

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

17-7-2018

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Revision: 7, Authorised

Europe - EMA - European Medicines Agency

17-7-2018

Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible Particles

MedEffect Canada

13-7-2018

Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid / colecalciferol, Revision: 12, Authorised

Europe - EMA - European Medicines Agency

27-6-2018

Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Revision: 1, Authorised

Europe - EMA - European Medicines Agency

21-6-2018

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Revision: 6, Authorised

Europe - EMA - European Medicines Agency

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Levothyroxine (sodium), Therapeutic area: Endocrinology, -gynacology-fertility-metabolism

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Treprostinil (sodium), Therapeutic area: Cardiovascular diseases

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, Sodium zirconium cyclosilicate, Therapeutic area: Endocrinology, -gynacology-fertility-metabolism

Europe - EFSA - European Food Safety Authority EFSA Journal

25-5-2018

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

17-5-2018

Human medicines European public assessment report (EPAR): Arixtra, fondaparinux sodium, Revision: 27, Authorised

Europe - EMA - European Medicines Agency

8-5-2018

Human medicines European public assessment report (EPAR): Elmiron, pentosan polysulfate sodium, Revision: 3, Authorised

Europe - EMA - European Medicines Agency

17-5-2017

Sodium Chloride Injection 0.9%, USP - Recall of Three Lots due to the Potential for Leakage of the Parenteral/intravenous Solution Bag

MedEffect Canada

6-9-2016

PRIMAXIN 500 (imipenem and cilastatin sodium) for injection - Incorrect Labelling Information

MedEffect Canada

2-8-2016

Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg/2 mL single-dose Act-O-Vial - Recalled Lots due to Potential for Dosing Error

MedEffect Canada

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

5-4-2018

Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Revision: 0, Authorised

Europe - EMA - European Medicines Agency

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety