The Importance of Following Your Doctor's Dosage Instructions

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).

• Levitra 20 mg Bayer is a popular choice for erectile health issues.
• It should not be used in combination with certain medications like alpha-blockers.
• Men with heart conditions should consult a doctor prior to use.
• The pill’s onset can vary between individuals, typically about 30 minutes.
• It is not an aphrodisiac, and sexual arousal is necessary for effectiveness.
• Levitra 20 mg Bayer is not intended for recreational use.
• The medication’s effectiveness can be influenced by age and health status.
• Overdose symptoms may include priapism, a painful erection lasting several hours.
• Pregnant or breastfeeding women should avoid using Levitra.
• Proper hydration can help reduce some side effects.
• Keep out of reach of children and protected from moisture.

Laboratory analysis revealed that both products lack active pharmaceutical ingredients, rendering them ineffective and unsafe for public use. 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.

• 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.

#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. #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 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. 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 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. It reinforces a transparent and harmonized approach to safety information management. 🌍 At Viginovix, we continuously monitor global pharmacovigilance and regulatory updates to help our partners uphold compliance, safety excellence, and readiness across all regions. 📩 info@viginovix.com & awanishpandey@viginovix.com 🌐 👉 What are your thoughts on how local regulatory clarifications contribute to global pharmacovigilance harmonization? #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 The levitra canadian drugs 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. To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US.

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Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy

USFDA approval is levitra price list considered a gold standard for pharmaceutical products globally. 2- UK MHRA (Medicines and Healthcare products Regulatory Agency) Regulates medicines and medical devices in the UK, ensuring their safety, quality, and efficacy. 3- FSSAI (Food Safety and Standards Authority of India) Regulates food safety and standards in India, ensuring the quality and safety of food products.

• 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.

Quality Standards 1- GMP (Good Manufacturing Practice) A set of guidelines ensuring pharmaceutical products are manufactured, tested, and packaged in a controlled environment to meet quality standards.

Product	Dosage	Quantity + Bonus	Price
Levitra Soft Tabs	20mg	180 + 10 Pills	398.14€ 379.18€	Buy
Levitra Generic	20mg	120 + 10 Pills	224.15€ 213.48€	Buy
Levitra Soft Tabs	20mg	270 + 10 Pills	521.78€ 496.93€	Buy
Levitra Generic	10mg	30 + 4 Pills	62.39€ 59.42€	Buy
Levitra Generic	40mg	30 + 2 Pills	93.58€ 89.12€	Buy
Levitra Generic	10mg	90 + 8 Pills	150.58€ 143.41€	Buy
Levitra Original	20mg	14 + 2 Pills	102.27€ 97.40€	Buy
Levitra Original	20mg	64 + 4 Pills	298.45€ 284.24€	Buy
Levitra Generic	60mg	120 + 8 Pills	372.33€ 354.60€	Buy
Levitra Generic	20mg	10 Pills	31.49€ 29.99€	Buy
Levitra Soft Tabs	20mg	120 + 8 Pills	288.52€ 274.78€	Buy
Levitra Soft Tabs	20mg	30 + 2 Pills	99.17€ 94.45€	Buy
Levitra Original	20mg	4 Pills	45.87€ 43.69€	Buy
Levitra Generic	60mg	10 Pills	47.42€ 45.16€	Buy

2- ISO 9000 A series of quality management standards that help organizations ensure their products or services meet customer and regulatory requirements. Research Methodologies 1- Double-blind placebo-controlled studies A research design where participants are randomly assigned to treatment or placebo groups, and both participants and researchers are blinded to the treatment assignments.

What happens if I miss a dose?

#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 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. 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 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. It reinforces a transparent and harmonized approach to safety information management. 🌍 At Viginovix, we continuously monitor global pharmacovigilance and regulatory updates to help our partners uphold compliance, safety excellence, and readiness across all regions. 📩 info@viginovix.com & awanishpandey@viginovix.com 🌐 👉 What are your thoughts on how local regulatory clarifications contribute to global pharmacovigilance harmonization?

Clin. Endocrinol. (Oxf)

#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 The levitra canadian drugs 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. To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. USFDA approval is levitra price list considered a gold standard for pharmaceutical products globally. 2- UK MHRA (Medicines and Healthcare products Regulatory Agency) Regulates medicines and medical devices in the UK, ensuring their safety, quality, and efficacy. 3- FSSAI (Food Safety and Standards Authority of India) Regulates food safety and standards in India, ensuring the quality and safety of food products. This design helps minimize bias and ensures the reliability of results.

• Levitra 20 mg Bayer is designed for adult men with ED.
• It should be used with caution in patients with liver or kidney issues.
• The medication may cause visual disturbances in some users.
• Levitra 20 mg Bayer does not protect against sexually transmitted infections.
• Measuring your response can help determine proper dosage.
• Avoid taking Levitra if you have any known allergies to it.
• Some users report improved confidence after taking Levitra.
• The drug can sometimes cause a mild decrease in blood pressure.
• You should not crush or chew the tablets; swallow whole.
• Use medication only as prescribed by a healthcare professional.
• Levitra 20 mg Bayer is part of a broader class of ED treatments.

2- Case trials studies Also known as clinical trials, these studies evaluate the safety and efficacy of new treatments or interventions in humans.

How should I use Levitra?

By adhering to these standards and guidelines, pharmaceutical companies. #pharmaregulatorycompliance# #pharmaqualityconyrolmeasures# #goodsmanufacturingpractices# #pharmanutraceuticals# To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated levitra spray mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. Previously, such tests were only required for raw materials, leaving finished syrups vulnerable to contamination. This regulatory change was prompted by a request from the Madhya Pradesh Food and Drugs Administration (MPFDA), which urged the inclusion of DEG and EG testing in the general monograph of the Indian Pharmacopoeia (IP).

Bayer Savings Card

In response, DCGI directed the Indian Pharmacopoeia Commission (IPC) to act immediately, leading to the issuance of ‘Amendment List-09’ to IP 2022. This amendment enforces mandatory DEG and EG testing for all oral liquid formulations, with permissible limits not exceeding 0.10%. The quantity must be measured using gas chromatography. The IPC also circulated the directive across India to relevant drug control authorities, laboratories, and pharmaceutical industry associations to ensure prompt implementation. This regulatory update addresses a critical loophole exposed by the repeated cough syrup-related deaths and aims to enhance drug safety and restore public trust in India's pharmaceutical regulatory framework. 3- Black box symbol A warning label required by regulatory agencies, such as the USFDA, to highlight serious or life-threatening risks associated with a particular medication. Intellectual Property and Standards 1- IP (Intellectual Property) Refers to patents, trademarks, copyrights, and trade secrets that protect innovations and creations in the pharmaceutical industry. 2- USP (United States Pharmacopeia) A non-profit organization that sets standards for the quality, purity, and identity of medicines, food ingredients, and dietary supplements.

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Quality Standards 1- GMP (Good Manufacturing Practice) A set of guidelines ensuring pharmaceutical products are manufactured, tested, and packaged in a controlled environment to meet quality standards. 2- ISO 9000 A series of quality management standards that help organizations ensure their products or services meet customer and regulatory requirements. Research Methodologies 1- Double-blind placebo-controlled studies A research design where participants are randomly assigned to treatment or placebo groups, and both participants and researchers are blinded to the treatment assignments. This design helps minimize bias and ensures the reliability of results. 2- Case trials studies Also known as clinical trials, these studies evaluate the safety and efficacy of new treatments or interventions in humans.

Pharmacotherapy for erectile dysfunction

3- Black box symbol A warning label required by regulatory agencies, such as the USFDA, to highlight serious or life-threatening risks associated with a particular medication. Intellectual Property and Standards 1- IP (Intellectual Property) Refers to patents, trademarks, copyrights, and trade secrets that protect innovations and creations in the pharmaceutical industry. 2- USP (United States Pharmacopeia) A non-profit organization that sets standards for the quality, purity, and identity of medicines, food ingredients, and dietary supplements. Journals and Publications 1- Peer-reviewed journals Scientific publications that publish research articles after rigorous review by experts in the field, ensuring the quality and validity of the research. 2-These regulatory bodies, quality standards, and research methodologies play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. Journals and Publications 1- Peer-reviewed journals Scientific publications that publish research articles after rigorous review by experts in the field, ensuring the quality and validity of the research.

Optimal Use of Levitra Tablets

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2-These regulatory bodies, quality standards, and research methodologies play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices.

Condition	Warning
Use of Nitrates	Contraindicated due to risk of severe hypotension
Severe Cardiovascular Conditions	Seek medical advice before use
Liver or Kidney impairment	Dose adjustment may be required
Hypersensitivity to Vardenafil	Avoid use

By adhering to these standards and guidelines, pharmaceutical companies. #pharmaregulatorycompliance# #pharmaqualityconyrolmeasures# #goodsmanufacturingpractices# #pharmanutraceuticals# To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US.

Side Effects and Safety Measures

#AsiaRisk #Regulation #India To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation.

General Dose Information

To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated levitra spray mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. Previously, such tests were only required for raw materials, leaving finished syrups vulnerable to contamination.

More about Levitra (vardenafil)

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.

Achieving treatment optimization with sildenafil citrate (Viagra(R)) in patients with erectile dysfunction

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. This regulatory change was prompted by a request from the Madhya Pradesh Food and Drugs Administration (MPFDA), which urged the inclusion of DEG and EG testing in the general monograph of the Indian Pharmacopoeia (IP). In response, DCGI directed the Indian Pharmacopoeia Commission (IPC) to act immediately, leading to the issuance of ‘Amendment List-09’ to IP 2022. This amendment enforces mandatory DEG and EG testing for all oral liquid formulations, with permissible limits not exceeding 0.10%.

Drug Category	Interaction Effect	Recommendations
Nitrates	Risk of dangerously low blood pressure	Do not combine
Alpha-blockers	Potentiates blood pressure lowering effects	Monitor blood pressure
Antibiotics (e.g., erythromycin)	Increased blood levels of Vardenafil	Cautious use advised
CYP3A4 inhibitors	Increased side effects	Dose adjustment necessary

The quantity must be measured using gas chromatography. The IPC also circulated the directive across India to relevant drug control authorities, laboratories, and pharmaceutical industry associations to ensure prompt implementation. This regulatory update addresses a critical loophole exposed by the repeated cough syrup-related deaths and aims to enhance drug safety and restore public trust in India's pharmaceutical regulatory framework. #AsiaRisk #Regulation #India To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation.

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