Cost, Insurance Coverage, and Generic Alternatives

#DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06

Trial purpose

𝗠𝗮𝗸𝗶𝗻𝗴 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 Sponsors may request changes to their ARTG entry to: 🔸Correct errors. 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in 📌𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗹𝗲𝗴𝗶𝘀𝗹𝗮𝘁𝗶𝘃𝗲 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗳𝗼𝗿 𝗹𝗶𝘀𝘁𝗲𝗱 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 This Therapeutic Goods Administration guidance helps sponsors understand how to legally list low-risk medicines (AUST L and AUST L(A)) on the Australian Register of Therapeutic Goods (ARTG). 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country. According to a statement issued on Wednesday, the counterfeit medicines identified are Efaston tablets (Dydrogesterone 10mg) and Paracare suspension 60ml (Paracetamol 120mg/5ml). Laboratory analysis revealed that both products lack active pharmaceutical ingredients, rendering them ineffective and unsafe for public use.

Phosphodiesterase Type 5 Inhibitors: The Day After

DRAP warned that such falsified drugs pose a serious threat to public health, potentially leading to treatment failure, worsening of illness, or life-threatening complications particularly for patients relying on them for essential therapies. The authority has advised citizens to stop using these products immediately and to consult healthcare professionals if they experience any adverse effects. Consumers have also been urged to verify batch numbers before purchasing medicines and to report suspicious products to local health authorities. In addition, pharmacies, hospitals, and healthcare providers have been instructed to monitor their supply chains closely and report any quality or safety concerns related to the two medicines to DRAP without delay. #DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country. October 2025 The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market.

Product	Dosage	Quantity + Bonus	Price
Levitra Soft Tabs	20mg	360 + 20 Pills	682.21€ 649.72€	Buy
Levitra Professional	20mg	270 + 6 Pills	738.98€ 703.79€	Buy
Levitra Generic	20mg	270 + 10 Pills	376.33€ 358.41€	Buy
Levitra Generic	10mg	120 + 10 Pills	178.59€ 170.09€	Buy
Levitra Original	20mg	8 Pills	65.05€ 61.95€	Buy
Levitra Generic	40mg	30 + 2 Pills	93.58€ 89.12€	Buy
Levitra Generic	60mg	120 + 8 Pills	372.33€ 354.60€	Buy
Levitra Original	20mg	64 + 4 Pills	298.45€ 284.24€	Buy
Levitra Generic	20mg	360 + 10 Pills	458.44€ 436.61€	Buy
Levitra Original	20mg	48 + 4 Pills	235.14€ 223.94€	Buy
Levitra Original	20mg	92 + 4 Pills	406.22€ 386.88€	Buy
Levitra Original	20mg	12 Pills	81.99€ 78.09€	Buy
Levitra Generic	10mg	10 Pills	28.93€ 27.55€	Buy
Levitra Generic	20mg	10 Pills	31.49€ 29.99€	Buy
Levitra Generic	20mg	120 + 10 Pills	224.15€ 213.48€	Buy
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Levitra Generic	20mg	90 + 8 Pills	180.78€ 172.17€	Buy

𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 ✓ Clear definition of electronic distribution and what constitutes electronic dissemination of safety information (Section: Dissemination of Safety Information) ✓ Clarification that safety information related to pharmaceutical forms not marketed in Iceland will not be assessed by the Icelandic Medicines Agency (Section: 1.6 Review by

• Levitra 20 mg Bayer is manufactured by Bayer Pharmaceuticals.
• It is often marketed under the brand name Levitra.
• The medication can be prescribed for men with erectile dysfunction.
• Levitra works by relaxing blood vessel muscles.
• It is available in tablet form for oral use.
• The recommended dose is usually 10-20 mg depending on need.
• Generics of Levitra 20 mg Bayer might be available in some markets.
• Patients should avoid heavy meals close to taking the medication.
• Common side effects may include nasal congestion and upset stomach.
• Levitra 20 mg Bayer may interact with certain blood pressure medicines.
• Always follow your doctor’s instructions when using Levitra.

the Icelandic Medicines Agency and Dissemination of Safety Information) ✓ Aimed at strengthening regulatory transparency and consistency in safety information handling 𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬 This update enhances efficiency and clarity in the regulatory process, ensuring streamlined communication and compliance for Marketing Authorization Holders (MAHs) operating within Iceland.

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Non-surgical management of erectile dysfunction

𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 Sponsors use the TGA Business Services portal to: 🔸Enter product details. 🔸Receive an AUST L or AUST L(A) number and certificate. 𝗣𝗼𝘀𝘁-𝗟𝗶𝘀𝘁𝗶𝗻𝗴 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 Once listed, sponsors must: 🔸Maintain pharmacovigilance records and report adverse events. 🔸Comply with any ingredient-specific conditions (e.g., standards for Ginkgo biloba). 🔸Notify the TGA of overseas levitra no prescription online recalls or safety issues. It reinforces a transparent and harmonized approach to safety information management.

More about Levitra (vardenafil)

For Healthcare Professionals: Stay vigilant for falsified or unregistered medicines. Report any suspected cases or adverse reactions to DRAP’s pharmacovigilance system. Always purchase medicines from licensed pharmacies and verify their registration details. Seek medical attention if you experience any unusual effects. Ensuring medicine safety is a shared responsibility.

Professional resources

Read the full notice here: 👉 Rapid Alert : #RegAlert #DRAP #Pharmacovigilance #DrugSafety #HealthcarePakistan #PublicHealth #PharmacyProfession #MedicineAlert #PatientSafety #QualityMatters To view or add a comment, sign in 🚨 RegAlert 067-025 Public Safety Notice The Drug Regulatory Authority of Pakistan (DRAP) has issued a Rapid Alert against an unregistered and substandard product being sold under the name Levitra 20 mg Tablet (Batch No. Read the full notice here: 👉 Rapid Alert : #RegAlert #DRAP #Pharmacovigilance #DrugSafety #HealthcarePakistan #PublicHealth #PharmacyProfession #MedicineAlert #PatientSafety #QualityMatters To view or add a comment, sign in 📌𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗹𝗲𝗴𝗶𝘀𝗹𝗮𝘁𝗶𝘃𝗲 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗳𝗼𝗿 𝗹𝗶𝘀𝘁𝗲𝗱 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 This Therapeutic Goods Administration guidance helps sponsors understand how to legally list low-risk medicines (AUST L and AUST L(A)) on the Australian Register of Therapeutic Goods (ARTG). 𝗟𝗶𝘀𝘁𝗶𝗻𝗴 𝗣𝗮𝘁𝗵𝘄𝗮𝘆𝘀 🔸There are two main types of listed medicines: 🔸AUST L medicines: These are low-risk and do not undergo pre-market efficacy review. 🔸AUST L(A) medicines: Also low-risk, but they require TGA assessment of efficacy evidence and may carry a “TGA assessed” claim. 𝗦𝗽𝗼𝗻𝘀𝗼𝗿 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 Sponsors must certify that their medicine: 🔸Is eligible for listing under the Act. 🌍 At Viginovix, we continuously monitor global pharmacovigilance and regulatory updates to help our partners uphold compliance, safety excellence, and readiness across all regions.

Condition	Description	Recommended use
Erectile Dysfunction	Difficulty in achieving or maintaining an erection	As prescribed by a doctor
Pulmonary Arterial Hypertension	Off-label use in some cases	Not approved without supervision
Menopause-related Sexual Dysfunction	Experimental treatment	Not approved officially

📩 info@viginovix.com & awanishpandey@viginovix.com 🌐 👉 What are your thoughts on how local regulatory clarifications contribute to global pharmacovigilance harmonization?

• Levitra 20 mg Bayer is supplied in blister packs for convenience.
• It is essential to adhere to prescribed timing and dosage.
• OTC availability varies by country; prescription is generally required.
• Patients should report any unusual eye or vision changes promptly.
• Levitra’s effects can be influenced by other health conditions.
• Men should avoid unnecessary driving or dangerous activities after use.
• The medication is part of a balanced approach to sexual health.
• Levitra may require dose adjustments based on individual response.
• Avoid using other ED medications simultaneously without medical advice.
• Nutritional supplements claiming to enhance ED are not regulated.
• Proper storage and handling ensure medication effectiveness.

#RegulatoryUpdate #Pharmacovigilance #DrugSafety #RegulatoryAffairs #Viginovix To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06 October 2025

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In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy. 2024 DRAP Updates: What You Need to Know This year, the Drug Regulatory Authority of Pakistan (DRAP) has made some important updates to improve the safety and quality of healthcare products in Pakistan. Here’s a quick breakdown of what’s new: 1. Streamlined Product Enlistment DRAP has made it easier for companies to get herbal, homeopathic, and nutraceutical products enlisted by releasing provisional FIFO lists for applications submitted in 2024.2.

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Stronger Pharmacovigilance The third edition of the National Pharmacovigilance Guidelines has been published, bringing the system in line with WHO recommendations to ensure safer medicines.3. Easier Reporting for Adverse Drug Reactions DRAP extended its E-Reporting System, making it simpler for companies to report safety concerns and help improve drug monitoring.4. Updated Fee Structure To improve services, DRAP revised the fees for 132 regulatory processes, aligning them with current needs.5. Support for Biological Product Trials A new draft guidance document provides a clear roadmap for conducting clinical trials of locally manufactured biological products.6. Good Clinical Practice (GCP) Inspections DRAP is ramping up inspections to ensure clinical trials meet international ethical and scientific standards.7. The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market.

Primary Outcome

Quality Alerts The authority has issued warnings about contamination risks in certain products, like ethylene glycol, to protect public health.8. Latest DRAP Newsletter The latest quarterly newsletter is packed with updates, including the extension of the e-reporting system and other initiatives to improve healthcare safety. These updates highlight DRAP’s efforts to ensure quality and compliance in Pakistan’s healthcare system. 🚨 RegAlert 067-025 Public Safety Notice The Drug Regulatory Authority of Pakistan (DRAP) has issued a Rapid Alert against an unregistered and substandard product being sold under the name Levitra 20 mg Tablet (Batch No. BXNZ2488), falsely claiming to be manufactured by Bayer Pharma AG, Germany.

Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile dysfunction: A systematic review and meta-analysis

Testing by price levitra 10mg the Central Drugs Laboratory confirmed that this batch is falsified and unregistered. Its safety, quality, and efficacy have not been evaluated or approved. Use of such medicines can result in treatment failure, adverse reactions, or serious health risks. Regulatory Action: DRAP has instructed its field and provincial authorities to seize this product. Pharmacies, distributors, and healthcare institutions are advised to check their inventories immediately and report any presence of this batch to the authorities.