Teva Pharmaceutical Industries Ltd. ADR

• Health Canada approves ^PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg.
• ^PrAJOVY® increases availability across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults.
• This approval marks an important step in enhancing the impact of ^PrAJOVY® beyond adults since its Canadian approval in 2020, and underscores Teva's ongoing efforts to advance and address neurological challenges.

TORONTO, Feb. 4, 2026 /CNW/ - Teva Canada Limited (Teva Canada) announced today that Health Canada has approved an expanded indication for ^PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. With this approval, ^PrAJOVY® becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for eligible pediatric patients, marking a meaningful advancement in expanding preventive treatment options for those living with migraine.

Migraine is a neurological disease that significantly impacts children and adolescents leading to missed school, reduced social participation, and wide-ranging effects on family life. With this approval, ^PrAJOVY® now offers a new, once-monthly preventive option to help reduce the frequency of migraine attacks for eligible pediatric patients.

"Migraine has a profound impact on children and teens, yet pediatric patients have historically had very few preventive treatment options", said Wendy Gerhart, Executive Director of Migraine Canada. "We welcome this approval as a meaningful step forward for families navigating this challenging condition. Having additional, evidence-based choices matters and may make a measurable difference in the day-to-day lives of young people living with migraine."

Health Canada's approval of this indication is based on the results of Phase 3 SPACE trial, which demonstrated that fremanezumab significantly reduced monthly migraine days and monthly headache days versus placebo over a 12–week period in pediatric patients with episodic migraine and showed a safety profile consistent with adults.¹

"As an investigator in the clinical study that supported this approval, I've seen firsthand the meaningful impact fremanezumab may have for young people living with episodic migraine", said Dr. Daniela Pohl, MD, PhD, Professor of Pediatric Neurology at the Children's Hospital of Eastern Ontario. "This is an important advancement for Canadian children and adolescents who have long lacked evidence-based preventive options. Having AJOVY available to this population gives clinicians and families a targeted therapy that can help reduce migraine burden and improve day-to-day well-being.

"We are proud to bring this important advancement to pediatric migraine care in Canada," said Fabien Paquette, General Manager of Teva Canada. "This approval reflects Teva's commitment to helping patients across all stages of life, and to ensuring families have innovative therapies backed by strong clinical science. Expanding the availability of AJOVY to younger Canadians underscores our long-standing dedication to neurological health and to closing gaps in care.

About ^PrAJOVY®

^PrAJOVY® is indicated for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. ^PrAJOVY® is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. ^PrAJOVY® can be administered either by a healthcare professional or at home by a patient 13 years of age or older or caregiver. No starting dose is required to begin treatment.

About SPACE

SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12–week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.

About Teva Canada

Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is proud to celebrate 60 years of serving the health of Canadians. As one of the world's largest suppliers of generic, biosimilar, and innovative medicines, we are all in for better health -- committed to delivering reliable, high-quality treatments. With facilities in Markham, Stouffville, Toronto, and Montréal, we employ over 850 people and manufacture 70% of the medicines we sell in Canada locally, reinforcing our commitment to accessibility and supporting the Canadian economy. Learn more at www.tevacanada.com.

Cautionary Note Regarding Forward–Looking Statements

This release includes forward–looking statements that are based on Teva's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include regulatory, market, and commercial factors, as well as those described in Teva's publicly filed reports. Forward–looking statements speak only as of the date of this release, and Teva undertakes no obligation to update them except as required by law

SOURCE Teva Canada

MONTRÉAL, Nov. 6, 2025 /CNW/ - Teva Canada welcomes the recent announcement from Québec's Ministry of Health regarding changes to the reimbursement framework for extended-release methylphenidate products. Effective December 11, 2025, the Régie de l'assurance maladie du Québec (RAMQ) will apply the "lowest price" method to the molecule category "methylphenidate (hydrochloride) Co. L.A (12 h)."

This reimbursement update ensures that patients in Québec will continue to have access to treatment options for attention deficit hyperactivity disorder (ADHD), including those that meet the province's new pricing criteria. ACT Methylphenidate ER® is currently the only generic medication recognized by RAMQ as interchangeable with Concerta® on their List of Medications marketed in Canada.

Teva Canada remains committed to supporting patients, caregivers, and healthcare professionals with high-quality, accessible solutions.

"At Teva Canada, everything we do begins with the patient. This update from the RAMQ, which follows a recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS), helps ensure that people living with ADHD in Quebec continue to have access to affordable, high-quality treatment options. Our commitment is to remove barriers to care and support healthcare professionals in delivering the best possible outcomes for patients."

- Fabien Paquette, General Manager, Teva Canada

Teva Canada continues to collaborate with pharmacists, prescribers, and patient advocacy groups to provide educational resources and support tools that enable informed treatment decisions.

About Teva Canada

Teva Canada, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and (TASE: TEVA), is proud to celebrate 60 years of serving the health of Canadians. As one of the world's largest suppliers of generic, biosimilar, and innovative medicines, We are all in for better health - committed to delivering reliable, high-quality treatments. With facilities in Markham, Stouffville, Toronto, and Montréal, we employ over 850 people and manufacture 70% of the medicines we sell in Canada locally, reinforcing our commitment to accessibility and supporting the Canadian economy. Learn more at www.tevacanada.com.

SOURCE Teva Canada