Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - cardiovascular - the biosense webster pentaray® nav and nav eco high-density mapping catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. the catheters are intended to obtain electrograms in the atrial and ventricular regions of the heart. the catheters provide location information when used with compatible carto® 3 ep navigation systems.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - cardiovascular - intended for the transseptal exchange of biosense webster preface™ braided guiding sheaths which are used for the introduction of intravascular electrophysiology catheters. the exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - cardiovascular - the biosense webster smartablate™ irrigation tubing set is designed for use with the smartablate™ irrigation pump to deliver irrigation solution at specified flow rates to celsius® thermocool®, navistar® thermocool®, or other irrigated devices for cooling purposes.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - cardiovascular - the biosense webster thermocool® smarttouch™ diagnostic/ablation deflectable tip catheter and related accessories are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. the thermocool® smarttouch™ diagnostic/ablation deflectable tip catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with carto® 3 navigation system.

European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastic agents - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status, please refer to section 5.1.abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. for further information as to her2 status, please refer to section 5.1.abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5.1).abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5.1).abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

Singapore - English - HSA (Health Sciences Authority)

biomedix singapore pte. ltd. - clinical chemistry - reagent for the measurement of beta-hydroxybutyrate concentration in human serum or plasma. this reagent is for use with biosystems analyzers. for in vitro professional use only in the clinical laboratory

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson pte ltd - cardiovascular - the biosense webster qdot micro uni-directional and bi-directional navigation catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation. the biosense webster qdot micro uni-directional and bi-directional navigation catheter provide a real-time measurement of temperature and contact force between the catheter tip and heart wall, as well as location information when used with the carto 3 system.

Australia - English - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 45061 - fixation anchor, soft-tissue, biodegradable - the smith & nephew biosure? regenesorb interference screw is an absorbable biocomposite interference screw with open lateral surface area for use in the fixation of ligament, tendon, soft tissue, or bone-tendon-bone repairs in knee procedures. the biosure regenesorb interference screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone grafts.

Ireland - English - HPRA (Health Products Regulatory Authority)

dsm sinochem pharmaceuticals netherlands b.v. - amoxicillin trihydrate; clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1)) - film-coated tablet - 500/125 milligram(s) - combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor - combination of penicillins, incl. beta-lactamase inhibitors - acute bacterial sinusitis (adequately diagnosed) acute otitis media acute exacerbations of chronic bronchitis (adequately diagnosed) community acquired pneumonia cystitis pyelonephritis skin and soft tissue infections in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis. bone and joint infections, in particular osteomyelitis.

Ireland - English - HPRA (Health Products Regulatory Authority)

dsm sinochem pharmaceuticals netherlands b.v. - amoxicillin trihydrate ; clavulanic acid (as potassium clavulanate, diluted with microcrystalline cellulose (1:1)) - film coated tablet - 875/125 milligram - amoxicillin and enzyme inhibitor - : combination of penicillins, incl. beta-lactamase inhibitors - acute bacterial sinusitis (adequately diagnosed) acute otitis media acute exacerbations of chronic bronchitis (adequately diagnosed) community acquired pneumonia cystitis pyelonephritis skin and soft tissue infections in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis. bone and joint infections, in particular osteomyelitis.