Ramelteon Tablets 8mg (Rozerem® / ロゼレム錠8mg)

Ramelteon Tablets 8mg (Rozerem® / ロゼレム錠8mg)

JPY ¥4,800

Japanese Melatonin Receptor Agonist (Ramelteon 8mg). Oral tablet for improvement of difficulty falling asleep in insomnia, administered once daily before bedtime. PTP 100 tablets (10 tablets x 10). Mfd. by Takeda Pharmaceutical Company Limited, Japan.

Bulk deal
Quantity Discount Discounted price
5 - 9 8% JPY ¥4,416
10 - 19 12% JPY ¥4,224
20 + 18% JPY ¥3,936
SKU: ROZ-8-TAB Category:

Description

Product Overview / 商品概要

Rozerem Tablets 8mg (ロゼレム錠8mg)
Generic: Ramelteon / ラメルテオン
Therapeutic Category: Melatonin Receptor Agonist / メラトニン受容体アゴニスト
Manufactured by: Takeda Pharmaceutical Company Limited / 武田薬品工業株式会社

Composition & Specification / 組成・規格

Active Ingredient: Ramelteon 8mg per tablet / 1錠中 ラメルテオン8mg
Additives: Lactose hydrate, Corn starch, Hydroxypropylcellulose, Magnesium stearate, Hypromellose, Copovidone, Titanium oxide, Yellow ferric oxide, Macrogol 6000 / 乳糖水和物、トウモロコシデンプン、ヒドロキシプロピルセルロース、ステアリン酸マグネシウム、ヒプロメロース、コポビドン、酸化チタン、黄色三二酸化鉄、マクロゴール6000
Appearance: Film-coated tablet, light yellowish-orange color, identification code 157, diameter 7.1mm, thickness 3.6mm, weight 135mg
外観: フィルムコーティング錠、うすいだいだいみの黄色、識別コード157、直径7.1mm、厚さ3.6mm、質量135mg

Indications / 効能効果

EN: Improvement of difficulty falling asleep in insomnia
JA: 不眠症における入眠困難の改善

Dosage and Administration / 用法用量

EN: The usual adult dose is 8mg of ramelteon administered orally once daily before bedtime.
JA: 通常、成人にはラメルテオンとして1回8mgを就寝前に経口投与する。

Contraindications / 禁忌

EN: Patients with a history of hypersensitivity to any component of this product; patients with severe hepatic impairment; patients receiving fluvoxamine maleate
JA: 本剤の成分に対する過敏症の既往歴のある患者、高度な肝機能障害患者、フルボキサミンマレイン酸塩を投与中の患者

Regulatory Information / 規制情報

Approval No.: 22200AMX00295
Sales Started: July 2010 / 2010年7月
Classification Code: 87119
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年

Packaging / 包装

Main Package (for sale): PTP 100 tablets (10 tablets x 10) / PTP 100錠（10錠×10）
Other Available Packages (by special order): PTP 100 tablets (10 tablets x 10)

Full product insert (添付文書) is attached as a downloadable PDF. For detailed precautions, drug interactions, and safety information, please refer to the official package insert.

Additional information

重さ 0.15 kg

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Export from Japan — Ramelteon Tablets 8mg (Rozerem®

🏭 Supply & Origin

  • Country of Origin: Japan
  • Regulatory Standard: PMDA (Japan) / GMP Compliant
  • Pharmacopoeia: Japanese Pharmacopoeia (JP)
  • Supplier: Mate Co., Ltd. — Licensed Pharmaceutical Wholesaler (License No. B14309, Osaka)
  • Supply Capacity: Full-line sourcing through Japan's regulated distribution channels

🚚 Shipping & Trade Terms

  • Incoterms: FOB Kansai International Airport (KIX)
  • Shipping: Air freight via B/L or AWB
  • Payment: 100% T/T in advance
  • Lead Time: 2-4 weeks after payment confirmation
  • Available Regions: EU, LATAM, APAC, Middle East, Africa

Request a Quotation

For pricing, MOQ, and regulatory documentation, contact our export team:

Email: kurimoto@mate-osaka.co.jp
Tel: +81-72-665-5736

All exports are conducted through proper regulatory procedures including customs clearance, B/L or AWB documentation, and T/T advance payment. We do not engage in hand-carry, cash transactions, or sales to unlicensed parties.

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